HiSiaddi is an innovative foreign trade service provider driven by both technology transformation and foreign trade services. We have established a "1+2+3+4=1" service system and can supply L-threonate magnesium from multiple well-known original manufacturers. With over a decade of market experience and continuous factory technology transformation cooperation, HiSiaddi possesses extensive experience resolving raw material compliance issues. Below is a case study of HiSiaddi’s full-chain compliance solutions for L-threonate magnesium.
For inquiries about L-threonate magnesium product compliance issues, please contact HiSiaddi customer service.
The purchaser is a premium German brain nutrition enterprise headquartered in Berlin, BRAINCARE GmbH, a leading local light luxury dietary supplement brand in Germany. Its products are sold in premium organic lines of Germany’s DM retail chain, pharmacy dispensaries at private neurology hospitals in Berlin, and wellness chain institutions in Zurich, Switzerland. Core product lines include premium brain health capsules and oral magnesium compound powder, all complying with EU Novel Food regulations, REACH legislation, Germany’s LFGB food regulations, and USP raw material standards. Target consumers include Germany’s middle class, high-stress scientific researchers, and middle-aged and elderly neurological wellness groups, with a stable annual purchase volume of 14 tons of L-threonate magnesium.
Previously, the client sourced certified raw materials from European and American manufacturers, and initiated Chinese raw material procurement in 2025 with an initial order of 8 tons. Prior to shipment, five major compliance barriers emerged related to EU novel food market access, REACH registration, import customs clearance notarization, third-party testing compliance, and production qualification traceability. The domestic supplier could only issue domestic quality inspection reports, lacked familiarity with EU import regulations, and could not complete full supporting overseas market access documents, putting the goods at risk of detention or return upon arrival. The client fully entrusted HiSiaddi to resolve all compliance challenges in one-stop mode.
L-threonate magnesium was officially included in the EU Novel Food Catalog in October 2024 (Regulation (EU) 2024/2694). EU regulations mandate imported raw materials to be accompanied by authorized dossier references, raw material compliance declarations, and patent traceability documents. Domestic cooperating manufacturers only hold China’s new food raw material filings without supporting EU Novel Food filing materials. German customs explicitly stated that shipments lacking Novel Food supporting documents would be detained upon port arrival and prohibited from domestic sales. Most domestic L-threonate magnesium manufacturers fail to distinguish between domestic national standard qualifications and EU market access qualifications and cannot issue EU-recognized novel food compliance statements.
German import requirements mandate raw material REACH pre-registration plus 16-item full English SDS complying with EU standard formats. Manufacturers’ original SDS documents are simplified Chinese versions with incomplete physicochemical test items and missing toxicological data, failing to meet EU chemical safety data sheet formatting requirements. Additionally, partial raw material impurity indicators were not filed in the REACH information database, preventing German importers from completing local import declarations to the European Commission Directorate-General for Health and Food Safety.
German customs mandate a Free Sales Certificate (CFS) issued by CCPIT with consular dual authentication from the German Embassy in China. Manufacturers can only issue self-made factory certificates, lacking official CCPIT CFS documents and familiarity with consular notarization procedures. Missing certificates prevent import commodity inspection completion, leading to high detention and warehousing fees for detained goods.
For the client’s products to be shelved in German pharmacies, raw materials must undergo SGS testing per dual standards of LFGB food contact safety and USP Pharmacopoeia. Manufacturers only supply Chinese national standard test reports with incomplete test items for heavy metals, solvent residues, and chiral impurities. German food and drug administrations do not recognize these Chinese-language reports, blocking finished product shelf registration approvals.
Warehousing and shelf audit requirements for Germany’s premium supermarkets demand notarized factory SC food production licenses, English notarized GMP system certificates, and production process compliance explanations. All domestic factory qualification documents are issued in Chinese without professional translation and notarization, failing the client’s brand supply chain audit process. Even if raw materials clear customs, they cannot be put into production for market launch.
1. HiSiaddi screened mid-to-high-end raw material manufacturers holding EU Novel Food filing authorizations (Magtein patented grades), coordinated with the brand to obtain official EFSA approval documents, cited legal provisions of Novel Food authorization (Reg. (EU) 2024/2694), and raw material compliance statement letters.
2. HiSiaddi drafted bilingual Chinese-English compliance traceability statements marking CAS No. 500304-76-7, raw material molecular formulas, and EU approved application scopes, and sorted patent authorization supporting materials for the German importer’s local EU filing, resolving Novel Food market access barriers.
1. Drawing on chemical compliance databases, we rewrote full English 16-item compliant SDS documents complying with EU CLP regulations, supplementing toxicological data, physicochemical parameters, impurity control limits, and storage & transportation safety specifications.
2. Raw material REACH pre-registration numbers were verified, and supplementary information on substance classification and exposure limits was filed. Documents bear official English factory seals to meet German customs chemical declaration standards, enabling the client to directly complete local import reporting in Germany to the European Commission Directorate-General for Health and Food Safety.
1. We collected factory business licenses, SC food production permits, and national new food raw material announcement documents to apply for official CCPIT Free Sales Certificates (CFS).
2. The full authentication process was completed sequentially: notary public notarization → Ministry of Foreign Affairs authentication → consular authentication by the German Embassy in China, issuing original documents recognized by German customs to meet statutory customs clearance document requirements for Germany.
1. Unified samples were sent to domestic SGS laboratories to conduct customized test items aligned with German market access standards: purity, elemental magnesium content, heavy metals (lead, arsenic, cadmium, mercury), organic solvent residues, microorganisms, and chiral isomers.
2. Full bilingual English SGS test reports were issued with LFGB and USP judgment criteria marked, with report numbers traceable on the official SGS website for German food and drug administration finished product filing and pharmacy shelf audit use.
1. Factory SC licenses, GMP system certificates, and national new food raw material announcement documents were professionally translated into both German and English.
2. The full set of qualification documents underwent notary public notarization and were bound into complete qualification archives delivered to the client for German brand supply chain warehousing audits, supplementing overseas traceability document requirements.
1. All compliance documents (Novel Food dossiers, REACH-SDS, consular-authenticated CFS, SGS dual-standard test reports, notarized qualification archives) were compiled and verified into unified English document portfolios.
2. The 8-ton L-threonate magnesium order was split into two shipments declared at Shanghai Port for transit to Hamburg Port. Goods cleared customs smoothly with zero detention or customs inspection relying on the complete compliance document set.
3. After raw material warehousing, re-inspection by Germany’s local third-party laboratories confirmed full compliance with all standards, enabling timely production of new brain health capsules and instant powder products for shelf launch in Germany’s premium pharmacy channels.
1. The client signed an annual framework procurement agreement for 14 tons, stipulating HiSiaddi’s pre-review of all compliance documents and advance processing of corresponding certificates for all subsequent batches.
2. When the client later expanded market channels to Austria and the Netherlands, HiSiaddi simultaneously adapted to import regulations of corresponding EU member states and supplemented supporting compliance documents for the Netherlands NVWA and Austria AMA as required.
Most domestic L-threonate magnesium manufacturers only focus on domestic compliance requirements with limited awareness of EU Novel Food, REACH, national consular authentication, and international pharmacopoeia standards, making it difficult to meet stringent market access rules for high-end European and American brands. High-end overseas brands lack familiarity with Chinese document processing, notarization, and third-party testing procedures, facing severe risks of goods detention or return due to compliance defects. Leveraging import and export compliance experience, HiSiaddi closes the full compliance loop covering novel food filing, REACH compliance, official certificate notarization, international third-party testing, and destination country customs clearance, securing long-term stable orders through comprehensive compliance support services.
For inquiries about L-threonate magnesium product compliance issues, please contact HiSiaddi customer service.
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