HiSiaddi is an innovative foreign trade service provider driven by both technology commercialization and export business. We have established a "1+2+3+4=1" service system and can supply lactase from multiple well-known original manufacturers. With over a decade of market experience and technological cooperation with manufacturers, HiSiaddi possesses extensive expertise in resolving cross-border compliance issues for enzyme products. Below is a full compliance rectification case for lactase cross-border procurement delivered by HiSiaddi.
Contact HiSiaddi customer service for more consultation on lactase product compliance issues.
Buyer: BioNature, a premium organic dairy group headquartered in Zurich, Switzerland, a leading mid-to-high-end dairy enterprise across the Alpine region. Its four core product lines include organic pasteurized fresh milk, lactose-free infant formula powder, premium Greek fermented yogurt and organic cheese, distributed to high-end organic supermarkets, star bakeries and imported maternal & infant retail chains across Switzerland, Austria and Liechtenstein. All products comply with four sets of market access standards: EU EFSA Food Enzyme Regulation (EC) No 1332/2008, German LFGB, Jewish KOSHER kosher certification and EU Labeling Regulation 1169/2011.
The group long sourced lactase from European manufacturers including Chr. Hansen and DSM, and launched a cost-reduction domestic substitution project in 2025 with a planned annual lactase procurement volume of 22 tons. After independent sampling and validation with three domestic lactase manufacturers, the client finalized a 12-ton initial shipment. Shortly before delivery, five major compliance barriers emerged covering strain filing, labeling compliance, raw material allergens, third-party certification and EU Responsible Person requirements. Swiss customs pre-inspection warned of cargo detention upon arrival at port.
The client’s original domestic manufacturers only held domestic national production qualifications and lacked familiarity with EU market access rules, rendering them unable to rectify compliance documentation. The project faced cancellation, and the client urgently entrusted HiSiaddi to deliver full-process compliance rectification covering domestic production adjustment to EU customs clearance formalities.
The domestic lactase adopted genetically modified Aspergillus niger for fermentation. The manufacturer only held domestic GB1886.174 food additive filing credentials and lacked EFSA strain safety assessment dossiers, microorganism traceability reports and inactivated strain DNA residual testing reports.
Per the EU positive list system for food enzymes, food enzymes without submitted strain toxicology, mutagenicity and strain inactivation verification documents are prohibited from use in EU food production. Swiss customs pre-inspection explicitly stated that cargo without complete strain compliance dossiers would be seized and returned upon arrival. Domestic manufacturers only produced per China’s national food additive standards and lacked experience preparing EU strain filing documentation, making independent supplementary dossier preparation impossible.
Lactase carriers incorporated skim milk powder and edible lactose, triggering two critical compliance risks:
1. Conflict with Jewish KOSHER kosher standards: Co-production lines processing dairy raw materials and enzymes cannot obtain kosher certification.
2. Violation of EFSA infant food allergen rules: EU regulations ban hidden bovine allergens in raw materials for zero-dairy clean-label infant dairy formulas. SGS pre-testing detected trace bovine protein in the batch, which would trigger full product recall risks if incorporated into mass production and fail Swiss food safety random inspections for end consumer goods.
The domestic manufacturer used labels complying only with Chinese national standards, printed solely in Chinese with product name and factory address. Missing mandatory elements included bilingual German/English full ingredient lists, fermentation strain source, allergen warning labels, EU manufacturer filing codes, storage conditions, applicable food categories and graded net weight marking. EU regulations mandate full ingredient disclosure on minimum food additive packaging; incomplete labels block customs clearance applications, and the local Swiss importer refused to accept non-compliant goods.
The manufacturer only provided domestic SC food production licenses and in-house self-inspection reports, lacking German LFGB food contact safety certificates, export-specific ISO22000 system certification, FAO/WHO specification conformity testing and official third-party heavy metal (lead, arsenic, cadmium, mercury) test reports. EU customs clearance requires original full test reports issued by ISO17025-accredited international laboratories (SGS/Intertek) accompanying all food enzyme shipments. Domestic manufacturers lacked experience coordinating international testing and could not complete full-item testing within a short timeframe.
EU regulations mandate that non-EU food raw material manufacturers appoint a locally qualified EU entity as a compliance responsible person, with full enterprise filing completed in the EU RASFF early warning system. Customs clearance requires verification of EC REP registration numbers and official authorization documents. Domestic manufacturers lacked local EU compliance partners, and the client (an end-product manufacturer) could not concurrently serve as the EC REP for raw material suppliers, creating an unbreakable customs clearance bottleneck.
Overlapping compliance issues left only 18 days of the original 45-day delivery window. Failure to complete rectification would force the 12-ton cargo to be resold domestically at a steep discount, with the client losing over 120,000 Euros invested in sampling and production line debugging. HiSiaddi was fully authorized to launch closed-loop compliance rectification.
1. Carrier formula replacement: HiSiaddi coordinated the manufacturer to remove skim milk powder and edible lactose from auxiliary formulations, replacing them with single-component non-GMO corn maltodextrin. Spray granulation processes were adjusted, and 5kg verification samples were re-produced for SGS allergen testing, confirming non-detection of bovine protein while meeting KOSHER raw material formulation standards.
2. Supplementary strain compliance documentation: Partnering with third-party domestic enzyme research laboratories, HiSiaddi compiled full technical dossiers aligned with EFSA food enzyme filing guidelines, including original strain source certificates, genetic modification process descriptions, Ames mutagenicity tests, 90-day subchronic toxicology reports and finished product live strain/exogenous DNA inactivation test reports. All technical files were translated into bilingual German/English versions for official EU filing.
3. Production line physical separation upgrades: Dedicated independent dust-free workshops were designated to separate dairy raw material and lactase production lines via physical barriers, eliminating cross-contamination risks and laying hardware foundations for annual KOSHER certification.
1. Expedited full-item notarized testing: HiSiaddi coordinated ISO17025-accredited international laboratories to conduct full testing per FCC, LFGB and JECFA international standards, covering enzyme activity tolerance, microbial indicators (E. coli, Salmonella, total plate count), four heavy metals, residual miscellaneous proteases, allergens, moisture and ash content. Notarized Chinese/English test reports were issued within 3 working days, with all indicators superior to EU statutory limits.
2. Supplementary system & special certification: Assisted the manufacturer in completing export-specific annual review of ISO22000 food safety management systems and updated HACCP compliance records. International kosher certification bodies were engaged to issue batch-specific temporary KOSHER certificates for the shipment to meet kosher channel supply requirements.
3. LFGB food safety certification: Completed powder food migration and sensory off-flavor testing to obtain German LFGB finished product compliance certificates for market access across Germany and Switzerland.
1. Compliance label redesign: Per EU Regulation 1169/2011, bilingual German/English inner and outer packaging labels were customized with all mandatory elements: legal product name, fermentation strain, full ingredient breakdown, allergen warning marks, manufacturer filing codes, applicable food scope, storage conditions, production date and shelf life. The factory replaced all outer packaging labels for the 12-ton cargo, with label filing archives retained for official record.
2. EU EC REP responsible person filing: Drawing on HiSiaddi’s established European food raw material network, a locally qualified compliance enterprise based in Zurich, Switzerland was appointed as the manufacturer’s EU Responsible Person. Full manufacturer information filing was completed in the EU RASFF system, with official EC REP authorization letters and registration numbers issued and logged into the EU customs enterprise database.
3. Consolidated customs clearance documentation: A complete file of original and electronic documents was compiled per Swiss customs declaration requirements, including certificates of origin, commercial invoices, packing lists, full certification reports, strain technical dossiers, EC REP filing documents and KOSHER certificates, submitted to the Swiss importer for pre-inspection in advance.
After rectification, expedited air freight samples were sent to the client’s Swiss laboratory for 45-day accelerated shelf-life testing and full-scale production pilot runs. Zero allergen precipitation was observed in infant yogurt formulations, lactose hydrolysis rates remained stable, and finished goods passed random inspection by the Swiss Federal Food Safety Authority, with all physical, chemical and compliance indicators meeting end-product production standards. The client formally confirmed rectified goods qualified for full-channel retail launch.
1. Smooth customs clearance of initial shipment: The delayed 12-ton lactase shipment was loaded on schedule. Cargo passed Swiss Zurich port customs inspection with a full set of compliance documents in one review, with no detention, seizure or container detention fees, enabling full-line mass production for the client. Comprehensive procurement costs fell by 31.2% compared with long-term European imported enzyme sourcing, optimizing finished organic yogurt factory costs and strengthening competitiveness of end retail pricing.
2. Annual framework order finalized: Supported by fully compliant domestic lactase supplies, the client expanded distribution to organic supermarket channels in Liechtenstein and signed a 22-ton annual framework procurement contract with monthly batch delivery. Based on this batch compliance rectification experience, the client raised additional sampling requests for three new high-purity lactase grades dedicated to special medical food.
3. Qualification upgrades for domestic manufacturers: With HiSiaddi’s support, the factory completed full EU compliance dossier preparation, unlocking market access to mid-to-high-end European dairy markets and escaping low-price bulk product competition. The customized grade commands a 35% premium over conventional food-grade lactase, generating subsequent sampling orders from organic dairy manufacturers in Austria and Finland.
4. Expanded compliance service system for HiSiaddi Foreign Trade: A standardized service workflow covering "compliance risk pre-assessment → raw material & production rectification → international testing & certification → EC REP filing → compliant label design → full customs documentation custody" was formalized. Leveraging practical lactase compliance experience, HiSiaddi expanded export compliance services for other food enzymes including dextranase and lipase targeting European markets.
Most domestic lactase manufacturers focus on production aligned with China’s national food standards and lack systematic understanding of multi-jurisdictional import regulations including EU EFSA, LFGB and KOSHER. Common hidden compliance vulnerabilities include incomplete strain documentation, carrier formulations incompatible with overseas clean label rules, labels designed solely for domestic standards and absence of EU Responsible Person filing. Stringent food safety regulations in Western European high-end dairy markets impose severe penalties for non-compliant raw materials, including port detention and costly full end-product recall losses. Overseas buyers lack access to full supply chain compliance information in China and cannot identify hidden compliance risks in raw materials, representing the core pain point of cross-border procurement.
Breaking free from traditional pure intermediary trading models, HiSiaddi conducts proactive compliance risk assessment based on target country market access regulations, delivering end-to-end solutions covering upstream factory production rectification, international certification processing and local EU compliance filing. The project helped Swiss mid-to-high-end clients avoid massive compliance losses and smoothly complete localized substitution of imported raw materials, while supporting domestic manufacturers to close international compliance gaps and enter premium European food raw material supply chains, delivering a triple win for overseas end clients, domestic manufacturers and the foreign trade service provider.
Contact HiSiaddi customer service for more consultation on lactase product compliance issues.
+86-13120989737 
info@hisiaddi.com 
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