As a new foreign trade service provider driven by both technology transformation and foreign trade services, HiSiaddi has established a "1+2+3+4=1" service system and can supply tetraphenylporphyrin from multiple well-known original manufacturers. With over a decade of market experience as a research-and-development-oriented new foreign trade enterprise, HiSiaddi has rich experience in product compliance issues through technological transformation cooperation with factories. The following is a case handled by HiSiaddi regarding compliance issues of tetraphenylporphyrin.
If you want to consult more compliance issues of tetraphenylporphyrin products, please contact HiSiaddi customer service.
The buyer, France’s PhotonMed SAS, is located in the biomedical science and innovation park of Lyon, France, deeply engaged in R&D and production of medical photodynamic drugs and minimally invasive tumor phototherapy reagents, with products supplied to clinical laboratories of French public hospitals and EU new drug R&D institutions. Tetraphenylporphyrin (TPP, CAS: 917-23-7) serves as a core intermediate of photodynamic API raw materials, and product market access must comply with EU REACH, CLP and local French pharmaceutical market access specifications. The enterprise purchases stable annual supplies of high-purity pharmaceutical-grade TPP totaling 1.8kg, previously sourced from high-purity reagents of Germany’s Merck. Faced with rising European raw material prices and extended lead times, the client planned to switch to domestic raw materials. After sample testing of a domestic porphyrin manufacturer passed standards, bulk orders were prepared. When 450g of stocked goods were ready for shipment to Le Havre Port in France, multiple compliance bottlenecks emerged, creating high risks of goods detention at the port. The client’s local French compliance specialists could not coordinate rectification with domestic factories, so they fully entrusted Shanghai HiSiaddi Technology (HiSiaddi) to coordinate full-chain compliance rectification.
The domestic original factory only held domestic production qualifications and lacked familiarity with EU chemical export regulations. All factory-supplied documents, packaging labels and component filings failed to meet EU market access standards. After initial submission of customs clearance documents, French customs issued a pre-warning directly, stating that if compliance materials could not be completed within 7 working days, the goods would be returned or destroyed. The client’s scheduled new drug pilot project faced delays and massive losses of test consumables.
The original factory only provided Chinese MSDS complying with national GB standards, without French SDS prepared in accordance with the latest REACH Regulation (EU 2020/878) of the EU. Mandatory content required in the 16 statutory chapters was missing, including screening of SVHC substances of very high concern, DNEL no-effect dose, ecotoxicological data and exposure scenario descriptions. Both French customs and the client’s pharmaceutical regulatory filing rejected the documents. The original SDS adopted simplified domestic GHS labeling for hazard classification, inconsistent with EU CLP hazardous material classification entries, with mislabeled GHS hazard pictograms, hazard statement H codes and precautionary statement P codes.
Tetraphenylporphyrin has EC number 213-025-9. French import regulations require filing of a EU-based REACH Only Representative (OR). The domestic factory failed to entrust local EU compliance institutions to complete filing. Trace heavy metals and by-product heterocyclic impurities remained from the product synthesis process, without full-component SVHC screening, making it impossible to issue a statutory declaration that SVHC substances are below the 0.1% limit. EU importers could not complete local import declarations.
The original factory self-declared an incorrect customs HS code, misclassifying the product as a general organic chemical. Tetraphenylporphyrin is classified as an irritant hazardous chemical (GHS07), a general hazardous goods category requiring corresponding hazardous material classification identification reports and UN compliant packaging certificates. The original factory used ordinary plastic bottles for subpackaging without UN hazardous packaging certificates or hazardous material labels, leading to failure to pass dual inspections at domestic customs and French ports.
Only simple Chinese labels were pasted on product bottles and outer cartons. The EU mandates bilingual French + English GHS labels, marked with product CAS number, EC number, hazard pictograms, EU representative information of manufacturers and storage warnings. All existing labels were invalid, and French entry inspection authorities prohibited warehouse receipt of goods.
HiSiaddi set up a special team of foreign trade compliance and fine chemical specialists to close all compliance rectification work within 6 working days, split into four core deliverables:
1.
Recompile EU-Compliant French Version SDS Documents Cooperating with CNAS-qualified domestic third-party testing laboratories, we re-measured product physical, chemical, toxicological and ecotoxicological data in accordance with Annex II of the latest REACH regulations and CLP classification rules, supplementing missing entries including DNEL values, waste disposal and cross-border transportation specifications to issue official French SDS with complete 16 statutory chapters, together with a spare English version directly usable for French pharmaceutical regulatory filing and customs clearance. We simultaneously corrected labeling of three hazard clauses: H315 skin irritation, H319 eye irritation and H335 respiratory irritation, and revised all P precaution statement content.
2.
3.
Entrust REACH Only Representative Filing in the EU and Complete SVHC Testing HiSiaddi partnered with local French compliance service providers to complete temporary EU OR Only Representative filing for this batch of TPP products. Samples were taken for GC-MS full-component screening to complete testing of 224 EU SVHC substances of very high concern, with an authoritative third-party test report confirming all SVHC substance contents of the product are below the statutory 0.1% limit, and issuing a compliance declaration document to complete statutory filing materials for EU import.
4.
5.
Correct Customs Classification, Supplement Hazardous Material Identification and Compliant Packaging We accurately confirmed the corresponding HS code of tetraphenylporphyrin as 29349990 and standardized customs clearance documents again. Samples were sent to a domestic hazardous material identification center to obtain a Hazard Characteristic Classification Identification Report. All goods from the original factory were repacked with UN-certified light-proof fluorinated hazardous bottles and UN cartons, with corresponding UN packaging use certificates obtained to complete domestic hazardous goods export declarations and avoid risks of customs detention.
6.
7.
Customize Bilingual GHS Labels Complying with French Regulations In accordance with French chemical labeling specifications, we designed bilingual French + English bottle stickers and outer carton labels, fully marking CAS 917-23-7, EC 213-025-9, GHS warning symbols, manufacturer information, EU Only Representative address and storage & transportation prohibitions. All batches of goods were re-labeled to meet inspection requirements at French entry ports.
8.
1. The originally detained 450g high-purity tetraphenylporphyrin smoothly completed domestic customs declaration and air freight clearance. Goods arrived at Lyon warehouses and passed dual inspections by French customs and pharmaceutical regulatory authorities in one go, being delivered on schedule for the client’s photodynamic new drug pilot tests. The client’s project was delivered as planned, avoiding test delay losses of nearly 16,000 EUR.
2. Subsequently, France’s PhotonMed SAS signed a long-term annual procurement framework of 1.8kg with HiSiaddi, agreeing that HiSiaddi would take full charge of pre-compliance review, SDS update, label control and REACH document maintenance for each batch of products, eliminating the client’s compliance coordination costs.
3. Supported by this successful French compliance delivery case, HiSiaddi replicated the standardized TPP compliance solution for two mid-to-high-end pharmaceutical clients in Spain and Italy, forming a standardized foreign trade service model of "raw material supply + full-process compliance trusteeship".
Most domestic fine porphyrin manufacturers focus on the domestic market and generally lack understanding of EU REACH, CLP and local labeling regulations of various countries. Product documents, packaging and filings are produced per domestic standards, easily triggering compliance detention risks during export to the EU. Mid-to-high-end pharmaceutical and optoelectronic clients in Europe and America are constrained by strict local chemical regulations and lack domestic resources to rectify compliance deficiencies.
Breaking the scope of simple raw material trade, HiSiaddi takes proactive control of four core export compliance links: SDS compliance, REACH filing, hazardous goods customs clearance and localized labeling. We remove regulatory barriers for domestic high-purity fine chemical products to enter Europe’s high-end supply chains by leveraging compliance capabilities.
If you want to consult more compliance issues of tetraphenylporphyrin products, please contact HiSiaddi customer service.
+86-13120989737 
info@hisiaddi.com 
English
