HiSiaddi is an innovative foreign trade service provider driven by both technology commercialization and export business, with a comprehensive service system framed as "1+2+3+4=1". We supply transglutaminase sourced directly from multiple well-known original manufacturers. With over a decade of market experience and technical cooperation with manufacturers, HiSiaddi possesses extensive expertise addressing product compliance issues. Below is a case of EU customs compliance remediation for transglutaminase completed by HiSiaddi. Please contact HiSiaddi customer service for further consultation on transglutaminase product compliance issues.
The buyer, Alpin Gourmet – an Alpine premium food company headquartered in Zurich, Switzerland, is a leading local mid-to-high-end meat enterprise specializing in organic restructured steaks, low-salt fermented air-dried hams, and premium processed cheese, supplied to high-end supermarkets and Michelin restaurants across Switzerland, France, and Italy. All products comply with six core EU market access standards: EC1332/2008 food enzyme regulations, LFGB, Clean Label, REACH, Kosher, and Halal certification. The group has an annual transglutaminase (TG enzyme) demand of 65 tons and historically sourced enzyme preparations from local European manufacturers. In 2025, a localization replacement program for Chinese TG enzymes was launched, with a trial order of 12 tons of customized TG enzymes finalized with a leading domestic manufacturer. The manufacturer independently handled customs declaration, documentation, and customs clearance arrangements.
Upon arrival at the Port of Rotterdam, the cargo was detained by a joint inspection team of the Netherlands Food and Consumer Product Safety Authority (NVWA) and EU Customs, blocked from pickup due to three concentrated compliance violations:
1. Strain compliance deficiencies: The manufacturer only provided domestic quality inspection reports, lacking EFSA safety filing documentation and non-GMO declarations for the TG production strain Streptomyces mobaraensis. EU regulations under EC1332 mandate full disclosure of strain traceability documentation for food-grade enzymes, making the submission incomplete and ineligible for EU market access per EFSA requirements.
2. Incomplete documentation portfolio: Missing EU-compliant SDS safety data sheets, full-scope LFGB third-party test reports, and certificate of free sale. COA test certificates only indicated enzyme activity without mandatory EU control indicators including heavy metals, microbial limits, and solvent residues.
3. Labeling & REACH regulatory gaps: Dual-language Chinese-English outer packaging labels failed to comply with EU food ingredient labeling standards and omitted indication of processing aid function. Carrier compound components lacked REACH pre-registration, with no EU Authorized Representative (EC REP) statement of conformity filed, triggering customs judgment of chemical control risks.
The client faced an imminent new product launch deadline, with daily storage, detention, and penalty fees accumulating for detained goods. Failure to complete supplementary documentation within the grace period would result in full return or on-site destruction of the 12-ton TG enzyme consignment, representing direct losses of nearly 72,000 euros. The manufacturer only possesses expertise in domestic commodity inspection standards and lacks familiarity with EU import compliance detailed rules. Introduced by the China-Europe Food Ingredients Association, the client entrusted HiSiaddi to fully oversee full-chain compliance remediation, supplementary certification preparation, and secondary customs clearance.
1. HiSiaddi coordinated with the production manufacturer to retrieve original strain breeding archives, strain identification reports, and non-GMO traceability files. In collaboration with domestic authoritative third-party testing institutions, full-scope physical and chemical, toxicological, heavy metal, microbial, and solvent residue testing was re-conducted per LFGB and EFSA evaluation standards, adding EU mandatory test indicators including lead, arsenic, cadmium, aflatoxin, thermostable bacteria, and solvent residues, with full English versions of test reports issued.
2. Assist the manufacturer in completing a notarized English original certificate of free sale issued by local market supervision authorities, confirming compliant domestic food-grade production and legal food processing application in China. Compile full strain compliance dossiers referencing the EU approved food enzyme list filing numbers for submission to NVWA for review and filing.
1. Rewrite English SDS safety data sheets in alignment with the latest REACH specifications, updating SVHC Substances of Very High Concern screening content and clarifying food-grade processing aid classification to eliminate chemical categorization risks.
2. Create batch-specific English COA and TDS technical datasheets detailing carrier ingredient composition, enzyme activity fluctuation ranges, applicable food categories, and recommended dosage rates. Consolidate notarized Kosher and Halal certificates, ensuring consistent data across all documentation to comply with Dutch customs declaration standards.
HiSiaddi coordinated with EU local compliance institutions to supplement REACH pre-registration documentation for product carrier compound components, contracted a certified EU EC REP authorized representative, and issued an official stamped statement of conformity. Full product notification was completed within the ECHA system to eliminate detention risks under EU chemical regulatory oversight.
In accordance with the EU Food Labelling Act, the manufacturer was guided to reprint outer carton English labels with standardized mandatory information: common name (Transglutaminase), enzyme activity, ingredient composition, production batch number, shelf life, storage conditions, food processing aid function, and country of origin. Compliant label samples were affixed to detained cargo packaging on-site for customs label verification.
Full sets of supplementary corrected documentation were submitted to NVWA and Rotterdam Customs in batches for regulatory verification. After 11 working days of compliance auditing, customs lifted detention orders and released the 12-ton TG enzyme consignment for delivery to the client’s production facility in Zurich, Switzerland. Small-batch trial production validated consistent performance of restructured steaks, fermented hams, and cheese across all physical and chemical indicators and sensory profiles, matching quality levels of original European imported TG enzymes and passing internal client quality control acceptance.
Full avoidance of 72,000 euros in direct losses from consignment return or destruction, guaranteeing on-schedule new product launch. Chinese TG enzyme unit prices decreased by 27.5% versus European imported raw materials, cutting annual raw material expenditure by over 110,000 euros. An additional 9 tons of TG enzymes were ordered for a new organic plant-based meat line the following year, establishing a permanent dual-brand Chinese raw material procurement framework.
Complete EU export compliance qualification archives were finalized, encompassing LFGB testing, EFSA strain filing, and REACH registration to form a standardized EU export compliance document package. Supported by this benchmark Swiss client case, sample trial invitations were secured from three equivalent premium meat manufacturers in France and Italy, enabling escape from domestic low-price competition.
A closed-loop full-chain TG enzyme EU export compliance service system was established covering strain compliance, third-party testing, documentation drafting, REACH registration, label compliance, and destination port customs clearance guidance, differentiating HiSiaddi from general trading companies that only provide cargo forwarding services. Supported by this successful Swiss compliance remediation case, multiple supporting compliance service mandates for TG enzyme import and export were secured with mid-to-high-end food enterprises across Austria and Germany.
Most domestic TG enzyme manufacturers maintain proficiency in domestic production standards yet lack comprehensive expertise covering multi-country EU food regulations, REACH chemical control rules, and importing country food authority audit detailed standards. Independent export shipments frequently trigger four core compliance loopholes: strain documentation gaps, incomplete testing reports, non-compliant labeling, and missing registration filings. Overseas mid-to-high-end food enterprises operate under stringent local regulatory frameworks, facing steep detention penalties and full consignment return risks upon submission of non-compliant documentation. Drawing on cross-border compliance resources and professional food regulatory expertise, HiSiaddi delivers one-stop closed-loop resolution of full-chain compliance pain points, delivering stable raw material supply for overseas premium clients, compliant overseas market expansion for domestic manufacturers, and a proprietary compliance service barrier for the foreign trade service provider – achieving a three-way win for all stakeholders.
Contact HiSiaddi customer service for further consultation on transglutaminase product compliance issues.