Modified Hydrotalcite Compliance Case: REACH Regulation & Label Violation Rectification

As a new foreign trade service provider driven by both technological transformation and foreign trade business, HiSiaddi has established a "1+2+3+4=1" service system and can supply original factory products of multiple well-known brands of modified hydrotalcite. Boasting over ten years of market experience as a foreign trade service provider with R&D capabilities, HiSiaddi has rich experience in product compliance issues through technological transformation cooperation with manufacturers. Below is a case of HiSiaddi handling compliance issues of modified hydrotalcite.

Please contact HiSiaddi customer service if you need more consultation on compliance issues of modified hydrotalcite products.

I. Client Background (Mid-to-High-End Positioning)

Client: Swiss PackSafe A top Swiss manufacturer of food-contact packaging materials, Swiss PackSafe specializes in high-transparency PVC/PE composite films, infant food containers and high-end daily chemical hoses, and has long served international brands including Nestlé and Swiss Food Group. The company complies with the world’s most stringent compliance standards including EU REACH, RoHS, EU Regulation 10/2011 on food contact materials and Swiss SR 817.040 standard for low heavy metals. As a compliance-driven mid-to-high-end client, its procurement decisions prioritize complete compliance documents, traceability and authoritative test reports with extremely low price sensitivity.

The client planned to purchase domestic modified hydrotalcite (thermal stabilizer & smoke suppressant) in bulk for its new generation of infant food packaging films. It had tentatively selected samples from a domestic brand yet encountered full compliance barriers in EU compliance audit, Swiss local filing, food contact testing and export documents, facing risks of order delay, project suspension and supplier replacement. It urgently entrusted HiSiaddi with full-process solutions including compliance diagnosis, testing rectification, document handling and customs clearance filing.

II. Core Compliance Barriers (Four Major Bottlenecks)

HiSiaddi immediately set up a special team combining compliance, technical and document specialists to sort out core compliance obstacles encountered by the client, all typical pain points for exporting high-end food-grade materials to the EU and Switzerland:

1. Non-compliance with REACH Regulation

· The supplier failed to provide full test reports for 247 SVHC Substances of Very High Concern (2025 latest list).

· No REACH registration/pre-registration completed, unable to provide Material Safety Data Sheets (MSDS) with missing ECHA notification information.

· Heavy metal testing (lead/cadmium/mercury) only covered five basic items without restricted substances specified in REACH Annex XVII; tested cadmium content reached 8ppm, exceeding the limit of ≤1ppm.

1. Missing food contact compliance documents (EU 10/2011)

· No test reports for Overall Migration Limit (OML) and Specific Migration Limit (SML) for food contact materials.

· No food contact tests conducted by EU-authorized laboratories (SGS/Intertek), disqualifying the product for infant food packaging.

· Residual chloride ion content reached 180ppm, exceeding the food-grade limit of ≤120ppm and posing migration risks.

1. Swiss local filing & label violations

· Non-compliant with Swiss SR 817.040 food contact material standard with no filing completed with the Swiss Federal Food Safety Authority (FOPH).

· Inconsistent Chinese and English product labels, missing GHS hazard labels and incomplete ingredient marking, leading to high customs clearance risks in Switzerland.

· No test reports recognized by Swiss local authorities, failing local audits.

1. Chaotic export documents & traceability system

· Chinese-only COA (Certificate of Analysis) provided by the supplier without English versions, with vague marking of key indicators (particle size, thermal decomposition temperature, heavy metals).

· Missing Certificate of Origin, Declaration of Conformity (DoC) and batch traceability reports, unable to meet EU/Swiss supply chain traceability requirements.

· No UN certification marks on packages, no moisture-proof and anti-pollution certificates, inconsistent with international maritime dangerous goods regulations.

III. Root Cause Diagnosis

Three core root causes were identified after verification:

1. Domestic suppliers lack compliance awareness, only conducting basic RoHS testing without special compliance layout targeting high-end food-grade markets in the EU and Switzerland.

2. No access to authoritative third-party testing resources, failing to conduct full tests via EU-recognized laboratories such as SGS and Intertek.

3. No professional foreign trade compliance team with insufficient familiarity with REACH registration, food contact filing and international document processing workflows, breaking the whole compliance chain.

IV. HiSiaddi Phased Full-Link Compliance Solution

(1) Step 1: Compliance Diagnosis & Risk Assessment (3 Days)

1. Sort out core requirements of four major regulations: REACH, RoHS, EU 10/2011 and Swiss SR 817.040, clarifying 12 mandatory test indicators, 8 essential documents and 3 filing nodes.

2. Conduct blind sample testing at SGS Shanghai Laboratory based on the client’s existing samples to lock three core risks: excessive cadmium, excessive chloride ions and missing SVHC testing.

3. Issue the Compliance Risk Report for Modified Hydrotalcite Exported to EU & Switzerland, specifying rectification priorities, test items, time schedules and budgets.

(2) Step 2: Product Rectification & Full-Scope Third-Party Testing (7 Days)

1. Raw material & formula optimization (cooperated with upstream factories)

· Adjust synthetic processes to reduce heavy metal impurities, lowering cadmium content from 8ppm to 0.3ppm (far below the 1ppm limit).

· Optimize water washing procedures to remove residual salts, reducing residual chloride ions from 180ppm to 95ppm (meeting the food-grade limit of ≤120ppm).

· Upgrade surface modifiers to food-grade stearic acid to eliminate risks of harmful substance migration.

1. Full-scope authoritative third-party testing (SGS/Intertek) Coordinate SGS to conduct 18 full tests covering four major categories to meet all compliance requirements:

· REACH Full-Scope Testing: No SVHC 247 items detected, all heavy metals (lead/cadmium/mercury/hexavalent chromium) compliant, with English test reports and ECHA notification documents provided.

· RoHS 2.0: No detection of 10 restricted hazardous substances, with EU-recognized RoHS certificates issued.

· Food Contact (EU 10/2011): Overall migration limit ≤5mg/dm² (superior to the standard limit of ≤10mg/dm²), no detectable specific migration substances, passing infant food contact grade testing.

· Swiss SR 817.040: All heavy metal and migrant substance indicators compliant, with test reports recognized by the Swiss Federal Food Safety Authority issued.

(3) Step 3: Document Preparation & Label Compliance Upgrade (5 Days)

1. Preparation of official English documents

· Recompile English COA with clear marking of key indicators including particle size (D50≤1.5μm), thermal decomposition temperature (≥325℃), heavy metal content and residual chloride ions, affixed with the factory’s official English seal.

· Issue EU Declaration of Conformity (DoC) signed and sealed by legal representatives, declaring compliance with REACH, RoHS and EU 10/2011.

· Apply for Certificate of Origin (CO) and Generalized System of Preferences Certificate of Origin (FORM A) to enjoy tariff reductions in Switzerland.

· Compile 16-section English MSDS complying with GHS standards, clarifying ingredients, hazard warnings and transportation requirements.

1. Label & packaging compliance upgrade

· Design bilingual Chinese-English labels with unified ingredients, hazard identification and warning statements, adding REACH registration numbers, food contact compliance numbers and batch traceability codes.

· Replace packages with UN-certified food-grade packaging equipped with additional moisture-proof and anti-pollution inner liners, marked with net weight, gross weight, batch number, production date and shelf life.

· Provide packaging compliance certificates, UN certification documents and moisture-proof test reports.

(4) Step 4: Swiss Filing & Customs Clearance Support (7 Days)

1. Swiss FOPH Filing

· Sort out full sets of English documents including SGS test reports, DoC, COA, MSDS and label samples.

· Entrust local Swiss compliance institutions to assist with food contact material filing and obtain Swiss filing numbers.

· Complete EU REACH notification simultaneously to ensure retrievable records in the ECHA system.

1. Customs clearance & traceability system construction

· Establish a batch traceability system enabling full-process tracking from raw material procurement, production and testing to packaging and export, with traceability reports provided for each batch.

· Conduct pre-audit of documents with Swiss customs in advance to avoid customs clearance delays.

· Track sea transportation and customs clearance throughout the process, providing real-time logistics information, document support and emergency response services.

(5) Step 5: Compliance Training & Long-Term Safeguards (Ongoing Service)

1. Provide the Compliance Manual for Modified Hydrotalcite Exported to EU & Switzerland, detailing regulatory requirements, test items, document processing and label specifications.

2. Train the client’s internal teams to master compliance audit key points, test report interpretation and supply chain compliance control.

3. Establish a quarterly compliance update mechanism to synchronize real-time updates of REACH SVHC lists and regulatory adjustments in the EU and Switzerland, ensuring long-term continuous compliance.

V. Rectification Outcomes & Closed-Loop Compliance System

1. Full compliance achieved

· REACH: No SVHC 247 items detected, cadmium content 0.3ppm, chloride ion residue 95ppm, all indicators compliant.

· Food contact: Passed EU 10/2011 infant-grade testing and Swiss SR 817.040 filing.

· Documents & labels: Complete full set of English compliance documents, consistent Chinese and English labels, UN-certified compliant packaging.

1. Smooth order delivery The first batch of 15 tons of modified hydrotalcite cleared Swiss customs smoothly and was put into production of infant food packaging films. Finished products passed Nestlé’s full compliance audit and entered formal mass production, completely eliminating order delay risks.

2. Cost optimization & long-term compliance mechanism

· Compliance rectification costs reduced by 40% compared with switching to imported brands with equivalent performance, realizing high-end domestic substitution.

· A long-term compliance mechanism was established, eliminating repeated testing and filing for subsequent orders and cutting delivery cycles by 50%.

1. Deepened trust & upgraded cooperation The client designated HiSiaddi as its exclusive Chinese procurement service provider for compliance, later adding procurement of food-grade, weather-resistant and high-transparency modified hydrotalcite, and entrusting HiSiaddi with compliance procurement of other high-end food-grade additives. Both parties established a strategic compliance partnership.

VI. Case Summary

For mid-to-high-end foreign clients purchasing modified hydrotalcite, compliance is not an optional bonus but a mandatory entry ticket. Especially for food contact materials, the EU and Switzerland impose stringent, long-chain and high-threshold compliance requirements which cannot be independently fulfilled by a single supplier or ordinary trader.

Breaking the traditional trader mindset of "only selling goods", HiSiaddi acts as a compliance expert, technical consultant and document manager, connecting the whole chain of product rectification, authoritative testing, document processing, overseas filing and customs clearance traceability to accurately resolve four major compliance bottlenecks including REACH compliance, food contact standards, local filing and label & document violations. We not only helped the client deliver orders on schedule but also built a long-term compliance system to avoid subsequent risks.

For mid-to-high-end clients, professional, full-link and implementable compliance solutions are equally important as prodrs and acts as a compliance bridge for clients entering high-end markets in the EU and Switzerland, achieving long-term win-win cooperation for both parties.

Please contact HiSiaddi customer service if you need uct quality. Leveraging compliance integration capabilities, authoritative resource coordination and localized services, HiSiaddi offsets the compliance weaknesses of domestic suppliemore consultation on compliance issues of modified hydrotalcite products.