As a new type 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 neotame sourced from multiple well-known original manufacturers. As a technology R&D-oriented foreign trade service provider with over ten years of market experience, we rely on technological transformation cooperation with factories and possess rich experience in product compliance issues. The following is a case of HiSiaddi handling neotame compliance problems.
If you want to consult more neotame product compliance issues, please contact HiSiaddi customer service.
The cooperating purchaser is BioCare AG based in Zurich, Switzerland, a leading domestic mid-to-high-end functional food enterprise in Switzerland. It operates high-end medicinal flavor masking powders, organic sugar-free infant complementary foods, low-temperature probiotic stock solutions, and hospital customized dietary supplements, with all product lines sold in premium organic Coop supermarkets across Switzerland, chain private hospital pharmacies in Zurich, and high-end health stores in southern Germany. Raw materials must comply with five access standards: EU Regulation EC1333/2008 on food additives, Swiss Food Act SR817.02, German LFGB, USP Pharmacopoeia, and EFSA safety assessment specifications, qualifying as a typical refined high-end raw material procurement client. The annual total neotame procurement volume totals 7.2 tons, split into two categories: pharmaceutical-grade coated neotame and acid-resistant beverage special neotame. The client previously purchased original European and American neotame long-term, and launched a Chinese-origin neotame import procurement project in 2025 affected by surging international raw material prices and extended delivery cycles of overseas factories.
The client independently contacted two major domestic neotame manufacturers and confirmed a 2.3-ton trial order for production preparation. Before shipment, five major cross-border compliance obstacles emerged successively. Domestic manufacturers only hold domestic production qualifications and can only provide national standard factory inspection certificates, lacking familiarity with EU and Swiss import access rules, labeling regulations, third-party notarized documents, and customs pre-declaration requirements. They could not complete full sets of compliance documents, risking cargo detention and return by Swiss customs upon arrival. The client’s new product launch timeline was urgent; cargo return would incur over 90,000 Euros in raw material losses and production line shutdown compensation losses. After multi-screening, the client fully entrusted HiSiaddi Foreign Trade with full services including full-process compliance rectification, document supplementary handling, and customs clearance implementation.
Factory self-inspection COAs are compiled solely against Chinese national standards, lacking EU mandatory test items: related impurity limits, heavy metals (lead, arsenic, mercury, cadmium), plasticizers, full microbial indicators, and process by-product limits. The EU legal number for neotame E961 is unmarked, and no English notarized versions of reports are available. Swiss customs explicitly reject factory self-prepared inspection certificates, requiring batch-by-batch English COAs issued by ISO17025 accredited third-party laboratories per the latest EFSA revised neotame quality standards, one certificate per batch with no cross-batch reuse. Meanwhile, pharmaceutical-grade neotame purchased by the client requires supporting DMF partially public technical dossiers and GLP toxicology profiles, which domestic factories lack standardized archived documents.
Original factory packaging only prints Chinese product names and net weight, without bilingual German + English labels per Swiss regulations. Missing mandatory information includes neotame E961 code, CAS number of raw materials, EU filing number of manufacturers, allergen prompts, storage conditions, applicable food categories, and country of origin statements. No moisture-proof and light-proof compliance marks are printed on inner and outer bags. Swiss Food Authority explicitly prohibits entry and warehousing of goods with unqualified labels.
Swiss customs require official certificates of origin, exit food hygiene certificates, notarized GMP production enterprise documents, non-GMO statements, and non-irradiation processing statements for food additive entry. Domestic factories do not prepare such export special documents for domestic sales and cannot independently contact commodity inspection and CCPIT for notarization procedures within a short timeframe. Missing pre-requisite documents prevent import filing with Swiss customs.
Factories default to general chemical HS codes for customs declaration, while neotame as a food additive has a dedicated tariff code. Misclassification leads to import tariff rate deviations and targeted customs inspection control. Swiss customs have intensified inspections of high-intensity sweetener classification misdeclarations in recent years; misclassification will result in full container detention and verification, delaying shipment for a minimum of 15–30 days.
The client’s purchased acid-resistant cyclodextrin coated modified neotame was only filed as standard food-grade neotame by domestic factories, while the modified carrier β-cyclodextrin lacked filing records for usage in the Swiss food additive catalog. End clients cannot complete raw material warehousing filing with Swiss food regulatory authorities, making raw materials unavailable for production even after customs clearance.
1. HiSiaddi contacted domestic third-party authoritative testing institutions with EU recognized qualifications to re-sample and test neotame corresponding to the 2.3-ton batch per EFSA 2025 neotame (E961) quality specifications, LFGB, and Swiss SR817.02 standards. Supplementary EU mandatory test items including by-products, trace impurities, plasticizers, and pathogenic bacteria were added. Batch-by-batch bilingual Chinese-English COAs with ISO17025 laboratory seals were issued, with each indicator benchmarked against EU limits and marked with E961 code and CAS number. Test reports were simultaneously notarized for foreign-related use.
2. Coordinated manufacturers to sort CMC production process dossiers and product stability accelerated test data, condensed English technical profiles for DMF public sections to meet technical document requirements for Swiss drug authority warehousing filing. Two independent sets of compliance quality inspection dossiers were issued separately for food-grade and pharmaceutical-grade neotame.
Per EU1169/2011 and local Swiss food labeling regulations, HiSiaddi issued standardized bilingual label templates specifying mandatory information: German + English product name, Neotame (E961), CAS:165450-17-9, manufacturer information, country of origin CHINA, net weight, batch number & shelf life, storage conditions, non-phenylalanine allergen prompt, and applicable product categories. Factories were coordinated to re-produce light-proof nitrogen-filled aluminum foil outer bags and small inner packaging bags, fully replacing non-compliant original packaging, with label samples notarized and archived on official Chinese government websites.
1. Assisted factories in completing domestic customs filing for export food additives, applying for exit food hygiene certificates from local commodity inspection departments.
2. Coordinated CCPIT to issue FORM A GSP certificates of origin to enjoy Swiss tariff preferences for Chinese food raw materials and reduce the client’s import tariff costs.
3. Uniformly processed notarization of GMP production qualifications, non-GMO statement notarization, and non-irradiation treatment statement notarization. All documents were translated into English with foreign-related notarization seals, and simultaneously uploaded to the Swiss customs import pre-review system for filing.
Relying on years of practical sweetener customs declaration experience, HiSiaddi confirmed the exclusive import and export HS code for neotame (food additive E961). Code classification explanations and product physicochemical certificates were submitted to domestic customs for pre-ruling, while classification documents were synchronized to the client’s Swiss import customs broker to unify declared codes, completely eliminating risks of classification errors, customs detention, and inspections while optimizing import tariff costs.
Addressing the carrier filing difficulty of cyclodextrin coated modified neotame, HiSiaddi sorted EU access documents and original manufacturer qualifications of β-cyclodextrin plus modified process descriptions, assisting the client in completing usage filing of modified compound raw materials with the Swiss Federal Food Safety and Veterinary Office. Compound compliance explanations of neotame + cyclodextrin were submitted to obtain official Swiss raw material usage approval documents, ensuring raw materials can be directly put into production after customs clearance.
1. Smooth Shipment & Customs Clearance: After completion of full compliance document rectification, the 2.3-ton neotame was loaded and shipped per the original schedule. Upon arrival at Zurich Port, Swiss customs verified full sets of notarized documents, compliant COAs, and label dossiers, completing one-time customs clearance release without inspections, detention, or return. Cargo was directly delivered to the client’s constant-temperature raw material warehouse and put into production on schedule.
2. Direct Client Benefits: ① Avoided nearly 90,000 Euros in losses including cargo return, port detention warehousing, and production line shutdown compensation; four new products launched on schedule in premium supermarkets and private pharmacies across Switzerland. ② Relying on FORM A certificates of origin, import tariffs for the full order were reduced by 17.2%, saving over 12,000 Euros in import taxes for a single procurement. ③ Full sets of compliance documents can be reused for subsequent orders; only batch-specific COAs require updates for the remaining 4.9 tons of annual neotame split procurement later, drastically shortening document preparation cycles.
3. Deepened Long-Term Cooperation: The client entrusted HiSiaddi with full responsibility for neotame and compound sweetener import compliance agency and model selection procurement for its Swiss domestic and Austrian subsidiaries. A new customized high-purity pharmaceutical-grade neotame procurement demand was added the following year, raising annual procurement volume to 10.5 tons. HiSiaddi simultaneously standardized this set of EU/Swiss neotame compliance processes into standardized compliance service solutions targeting mid-to-high-end European dietary clients.
4. Factory Empowerment Benefits: The two cooperating domestic neotame factories improved full sets of EU export qualification document systems via this compliance rectification, supplemented LFGB and EFSA corresponding product testing specifications, and subsequently secured three additional procurement orders from mid-to-high-end European food enterprises relying on standardized compliance documents, opening access channels to high-end European raw material markets.
Most domestic neotame manufacturers focus on domestic national standard domestic sales markets, lacking reserves of food regulations for various European and American countries, and can only provide conventional domestic factory documents. They are unfamiliar with segmented compliance rules including EU EFSA, local national food bills, labeling, notarization, and import filing. Overseas mid-to-high-end clients who independently contact factories easily fall into compliance predicaments such as missing documents, non-compliant labels, blocked filing, and customs detention.
Relying on cross-industry chain compliance resources and national food regulation databases, HiSiaddi resolves full-chain compliance issues from five dimensions: quality inspection documents, packaging labels, notarized certificates, customs declaration classification, and excipient filing. Breaking out of simple commodity trade, we remove regulatory barriers for Chinese raw materials to access high-end European markets as a compliance service provider. This not only safeguards overseas mid-to-high-end clients’ procurement timelines and production costs, but also supports high-quality domestic sweetener manufacturers to enter the global high-end supply chain through compliant channels, serving as a typical implementation case of foreign trade enterprises empowering cross-border mid-to-high-end raw material procurement via compliance services.
If you want to consult more neotame product compliance issues, please contact HiSiaddi customer service.
+86-13120989737 
info@hisiaddi.com 
English
