HiSiaddi is an innovative foreign trade service provider driven by both technology commercialization and cross-border trading. It has built a "1+2+3+4=1" service system and can supply bromelain powder sourced directly from multiple well-known original manufacturers. Boasting over a decade of market experience and factory technology transformation cooperation, HiSiaddi possesses extensive expertise addressing product compliance challenges. Below is a case study of HiSiaddi’s bromelain export compliance resolution.
Please contact HiSiaddi customer service if you require further consultation on bromelain product compliance issues.
Purchaser: NaturaSuisse Group, a premium nutrition pharmaceutical enterprise headquartered in Zurich, Switzerland. As a leading mid-to-high-end dietary supplement brand in Switzerland, its core product lines include medical-grade digestive enzyme capsules, post-operative repair dietary supplements and organic maternal & infant nutritional products. Its goods are sold in Swiss chain pharmacies, premium organic supermarkets and private medical institutions nationwide. Market access compliance requirements cover EU EC1332/2008 enzyme regulations, Swiss FOODS safety legislation, German LFGB, FDA GRAS, dual Kosher & Halal clean food certifications and REACH chemical regulations. The group maintains annual bromelain procurement of 16 tons and previously sourced high-purity enzyme powder imported from France for years.
To streamline supply chain costs, the client selected 1800 GDU microencapsulated bromelain powder manufactured by a mid-tier domestic enzyme producer and confirmed an initial 3-ton order for stock preparation. Shortly before production completion and shipment scheduling, multiple critical compliance flaws were identified during document review by the client’s risk control department, preventing completion of Swiss import filing and European customs pre-declaration. Failure to rectify issues within the deadline would block full shipment delivery, resulting in loss of pre-paid raw material deposits and a two-month delay to new product launch plans. The client urgently entrusted HiSiaddi’s foreign trade team to fully oversee comprehensive compliance rectification.
The supplier held a domestic food production license but lacked FSSC22000 and ISO22000 international food safety system certificates. Per 2025 EU new regulations, food enzyme manufacturers outside the EU without FSSC22000 certification cannot complete EU EINECS filing, and Swiss customs reject raw material import declarations. Additionally, a Certificate of Free Sale issued by the China Council for the Promotion of International Trade (CCPIT) was missing, eliminating evidence of legal domestic circulation required for Swiss food and drug administration market access filing.
1. Lactose was selected as a carrier excipient by the manufacturer. EU regulations mandate full labeling of dairy-derived allergens, conflicting with the client’s zero-lactose clean label positioning for infant supplementary food-compatible products and violating Swiss labeling laws.
2. Internal heavy metal (lead, arsenic, cadmium) control limits followed national Chinese standards, while EU EFSA limit thresholds are 30% stricter; tested raw material heavy metal levels exceeded Swiss market access cutoffs.
3. No fully English SDS safety data sheets compliant with REACH regulations or SVHC Substances of Very High Concern screening reports were available. Rotterdam transit port customs explicitly stated cargo detention and return without complete SDS documentation.
The manufacturer’s Certificate of Analysis (COA) consisted solely of in-house self-test reports without third-party laboratory endorsement from CNAS-accredited facilities, which are not accepted by Swiss food and drug administration authorities. Kosher and Halal certifications issued by small domestic institutions were excluded from the EU recognized certification body whitelist and could not be used for import customs filing. Furthermore, the EU statutory enzyme additive E-code E1101 was unmarked on products, violating EC1332 regulatory labeling requirements for raw materials.
Outer packaging failed to comply with EU labeling rules, omitting mandatory markings: country of origin "PRODUCT OF CHINA", authorized EU representative information, descending full ingredient lists and allergen warning statements. Inner pouch materials lacked LFGB food contact material migration test reports, creating risks of excessive harmful substance migration and cargo detention via customs sampling upon arrival.
1. HiSiaddi coordinated certification bodies to expedite FSSC22000 system annual audit supplementary certification, obtaining valid certificates within 12 working days. Leveraging factory product testing records, CCPIT application materials were submitted to apply for bilingual notarized and authenticated Certificates of Free Sale for Swiss food and drug administration filing.
2. A local European compliance service provider was appointed as the legal EU Authorized Representative (ECREP) for the client, supplementing overseas manufacturer filing documentation to input factory and product data into the EU ECHA system and obtain an EU filing number, fulfilling REACH pre-requirements.
1. Manufacturers were coordinated to fully eliminate lactose excipients and replace carriers with single non-GMO edible corn maltodextrin for small-batch re-production and sampling. Third-party laboratories with ISO17025 accreditation conducted full-item SGS testing per EU standards: all 14 priority allergens (milk, lactose, gluten etc.) were undetected, and heavy metal indicators met Swiss FOODS limit requirements, issuing bilingual compliant test reports.
2. Complete REACH supporting documentation was simultaneously finalized: compliant English SDS safety data sheets and SVHC screening reports were drafted, listing bromelain CAS No. 9001-00-7 and statutory E-code E1101 to satisfy European chemical regulatory declaration requirements.
1. Manufacturers were assisted in re-applying for international standard dual Kosher & Halal certifications via bodies listed on the EU official whitelist, with certificates verifiable on European and American government systems.
2. Authoritative COA product analysis certificates were re-drafted based on verified third-party SGS test data, fully disclosing enzyme activity, microbial indicators, impurities and additive specifications to replace the original unrecognized in-house self-test reports and pass Swiss food and drug administration pre-review.
1. Inner and outer packaging raw materials were replaced, with packaging manufacturers supplementing LFGB food contact material migration test reports. HiSiaddi redesigned bilingual outer packaging labels in compliance with EU labeling legislation, standardizing mandatory markings including country of origin, ingredient sorting, allergen warnings, EU representative address, shelf life and E-code labeling. All content was finalized for mass printing after confirmation by the Swiss importer’s compliance department.
2. Full customs declaration documentation was organized: Certificates of Origin, commercial invoices and packing lists were cross-referenced to match all product filing information. Pre-shipment EU FDA pre-declaration was completed in advance to obtain PN release codes.
After completing all rectification work, HiSiaddi conducted online document final review together with the client’s Swiss risk control team alongside secondary sample re-testing, confirming all documents, test reports and certifications fully satisfy dual Swiss and EU market access standards and clearing the goods for shipment.
1. NaturaSuisse Group (Switzerland): The full 3-ton cargo was loaded and shipped on schedule, passing smoothly through Rotterdam transit and Zurich Swiss customs without detention or additional port storage charges. Raw materials produced finished products fully compliant with Swiss food and drug administration sampling standards, enabling timely new product launch in Swiss premium pharmacies. Based on this successful compliance implementation, the client finalized a 16-ton annual framework procurement contract, cutting raw material procurement costs by 31% compared to French imported supplies.
2. Domestic Manufacturer: The full portfolio of international compliance qualifications was supplemented, enabling product entry into premium nutrition supply chains in Switzerland and Austria. Subsequent complete compliance documentation secured sample trial orders from two mid-to-high-end brands in Norway and Finland, lifting product premium margins by 28% and eliminating limitations restricting sales solely to low-end domestic food manufacturers.
3. HiSiaddi Foreign Trade Service Provider: Established standardized EU/Switzerland bromelain export compliance workflows, forming a one-stop compliance service covering "qualification audit – formula compliance optimization – certification agency services – label revision – customs pre-inspection", breaking compliance barriers preventing domestic enzyme manufacturers from accessing premium European dietary supplement markets.
Most domestic bromelain manufacturers are proficient in production per Chinese national standards but lack in-depth understanding of specialized EU/Swiss food legislation, dedicated enzyme directives, REACH chemical control and granular clean label rules. Factory finished products frequently exhibit compliance vulnerabilities including unrecognized certifications, allergen-containing formulas and non-compliant packaging labels. Overseas mid-to-high-end nutrition enterprises operate under strict local food and drug regulatory frameworks; a single missing compliance document risks full cargo detention or return at port. Drawing on cross-country food regulatory databases, HiSiaddi dissects compliance risks end-to-end covering raw material formulas, qualification certifications, packaging labels and cross-border declaration, implementing rectification solutions in advance. The service helps overseas mid-to-high-end clients avoid massive cargo loss while enabling high-quality domestic enzyme manufacturers to complete international compliance qualification upgrades and smoothly access the global premium dietary supplement raw material supply chain, achieving a win-win-win outcome for purchasers, manufacturers and foreign trade service providers.
Please contact HiSiaddi customer service if you require further consultation on bromelain product compliance issues.
+86-13120989737 
info@hisiaddi.com 
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