Why IMDG compliance has become increasingly important for Vietnamese exporters

Manufacturers exporting chemicals, charcoal, batteries, industrial materials, aerosols, flammable products and other dangerous goods by sea face an increasingly complex compliance environment.

The 2024 Edition of the International Maritime Dangerous Goods Code incorporating Amendment 42-24 became mandatory on 1 January 2026.

The IMDG Code provides the regulatory framework for dangerous goods and marine pollutants transported by sea and covers key areas including: classification, packing, marking, labelling, placarding, documentation, packaging construction and testing, transport operations, segregation, stowage, and training.

For manufacturers, IMDG compliance therefore extends far beyond preparing a Safety Data Sheet before shipment. A robust system should connect:

Product Classification → Packaging → Factory Controls → Documentation → Container Packing → Carrier Acceptance.

What is the relationship between the UN Model Regulations and the IMDG Code?

The UN Recommendations on the Transport of Dangerous Goods – Model Regulations provide the internationally harmonized framework for the transport of dangerous goods.

The latest edition is Revision 24, published in 2025.

The Model Regulations address areas such as dangerous goods classification, packaging, marking, labelling, placarding and transport documentation.

The IMDG Code applies and develops relevant requirements specifically for maritime transport.

For exporters, the practical compliance sequence generally begins with:

UN Number → Proper Shipping Name → Class → Packing Group → Special Provisions → Packing Instruction → Packaging → Marks & Labels → Dangerous Goods Declaration → Container → Sea Transport.

An error at the classification stage can affect every subsequent step.

Who needs IMDG compliance consulting?

The service is particularly relevant to:

• chemical manufacturers;
• charcoal manufacturers and exporters;
• battery manufacturers;
• electronics companies shipping lithium or sodium-ion batteries;
• paint and coating manufacturers;
• solvent and adhesive manufacturers;
• aerosol manufacturers;
• industrial material exporters;
• logistics providers;
• warehouses;
• freight forwarders;
• manufacturers facing customer or carrier dangerous-goods requirements.

Service 1 – Dangerous Goods Classification Review

The first stage is a technical review of available product information, which may include: SDS, COA, Technical Data Sheet, composition, physical and chemical properties, manufacturing process, existing laboratory data, and previous transport classification.

The purpose is to establish or verify the applicable UN Number, Proper Shipping Name, Class, Subsidiary Risk, Packing Group, Special Provisions and Packing Instructions.

Where the available evidence is insufficient, additional technical information or testing may be required.

Service 2 – IMDG Compliance Gap Assessment

A factory-level assessment can cover:

• Product controls — classification and transport information.
• SDS controls — accuracy and consistency of transport information.
• Packaging — selection, approval and production control.
• Marking and labelling — package and overpack requirements.
• Container controls — inspection, packing and placarding.
• Documentation — Dangerous Goods Declaration and supporting records.
• Training — competence of personnel involved in dangerous goods activities.
• Emergency preparedness — response to damaged packages, spills, fire and other incidents.

The assessment results in a structured Gap Assessment Report and Corrective Action Plan.

Service 3 – IMDG Compliance System Development

Rather than treating every shipment as a separate emergency, manufacturers can establish a controlled compliance system. Documents may include: Dangerous Goods Register, Classification Review Procedure, Packaging Control Procedure, Marking and Labelling Checklist, Container Packing Checklist, Dangerous Goods Documentation Procedure, Training Matrix, Emergency Response Procedure, Internal Audit Checklist, and CAPA Tracker.

This allows the company to demonstrate how compliance is consistently managed.

Service 4 – UN Packaging and UN Mark Support

Dangerous goods cannot always be shipped in ordinary commercial packaging. Depending on the classification and applicable packing instruction, a package may need to meet UN specification packaging requirements.

Packaging can include: fibreboard boxes, plastic boxes, bags, drums, jerricans, composite packaging, and IBCs.

A UN Packaging support project may include: packaging design review, packaging code review, material and construction review, gross mass review, closure system review, Packaging Technical File preparation, test plan preparation, sample preparation, coordination with a competent third-party testing/approval organization, review of testing and approval documentation, and production and marking controls.

Can a manufacturer simply print a UN Mark on its packaging?

No. A UN specification marking should correspond to an appropriately tested and approved packaging design under the applicable authorization mechanism.

A company should verify: the approved packaging design, packaging code, performance level, maximum permitted mass or other applicable limits, contents covered, manufacturing specification, and marking authorization.

Changing the board grade, plastic material, dimensions, closure system, liner or other critical design characteristics may affect the validity of the approved design. This is why packaging change control should be part of the compliance system.

Service 5 – IMDG Training and Competence Development

IMDG compliance involves multiple departments. Relevant personnel may include: EHS, Production, Warehouse, Packing, Logistics, Export, Shipping Documentation, Quality, and container-loading supervisors.

Training should be relevant to actual job functions rather than limited to general awareness. A practical training programme may cover:

Classification → UN Number → Dangerous Goods List → Packaging → Marks & Labels → DGD → Container Packing → Segregation → Emergency Response.

Training records and competence assessments should be maintained.

Service 6 – Mock Audit and Shipment Readiness

Before the first shipment, a mock audit can verify whether the documented system is actually working. The review can include: physical packaging, package marks and labels, container placards, packing records, DGD, training evidence, traceability, container condition, and emergency controls.

Open issues can then be corrected before the shipment is presented to the carrier.

Special consideration for charcoal exporters

Charcoal is one of the areas receiving significant attention under IMDG Amendment 42-24. For applicable charcoal products, UN1361 CARBON, animal or vegetable origin, Class 4.2 and Special Provision 978 need particular attention.

Factory controls may need to address: production date, cooling/weathering, packing date, material temperature, approved packaging, container packing, headspace, Dangerous Goods Declaration, and carrier-specific requirements.

This means charcoal compliance begins at the manufacturing site — not at the port.

Carrier requirements can exceed baseline IMDG controls

Exporters should also understand the distinction between IMDG compliance and carrier acceptance requirements.

A carrier may introduce additional operational controls based on its risk-management policies. For example, updated 2026 requirements published for charcoal UN1361 shipments from Vietnam by a major ocean carrier include additional thermal protection and carrier-nominated vanning survey requirements.

Therefore, a good compliance programme should include a carrier-specific requirement review before shipment.

Is there an “IMDG Certificate” for a factory?

The IMDG Code should not be presented as a conventional management-system certification programme comparable to ISO 9001 or ISO 14001.

Depending on the project, a company may obtain or maintain: training completion certificates, compliance assessment reports, verification reports, third-party packaging test reports, and packaging approvals or certifications under an applicable scheme.

Where formal testing, approval or authorization must be issued by a competent third party, ISC Global and Staunchly Vietnam coordinate the process rather than replacing the legal role of that organization.

Our proposed project approach

A typical project can be structured into the following phases:

• Phase 1 – Regulatory and Classification Review
• Phase 2 – Factory IMDG Gap Assessment
• Phase 3 – Compliance System Development
• Phase 4 – UN Packaging Technical Review
• Phase 5 – Training and Competence Assessment
• Phase 6 – Third-Party Testing/Approval Coordination
• Phase 7 – Mock Container/Vanning Assessment
• Phase 8 – Final Compliance Verification

This integrated approach connects regulatory requirements with actual factory operations.

Why work with ISC Global and Staunchly Vietnam?

ISC Global focuses on training, consulting, international standards, ESG and compliance implementation. For dangerous-goods projects, the scope can include: regulatory review, IMDG gap assessment, system development, technical documentation, packaging preparation, CAPA, training, and audit readiness.

STC VN Co., Ltd. – Staunchly Vietnam supports: training, project coordination, assessment and verification, international-standard related services, and coordination with specialized testing, certification and verification partners.

Where a competent laboratory, approval organization, surveyor or other authorized third party is required, the project can be coordinated with the appropriate provider.

Contact us for IMDG and UN Packaging consulting in Vietnam

ISC Global

Hotline/Zalo: +84 933 096 426 – +84 868 591 260

Email: info@iscglobal.asia | van.pham@iscglobal.asia

Website: iscglobal.asia | iscglobal.edu.vn

As global buyers and retailers tighten sourcing requirements around traceability and deforestation-free supply chains, RSPO (Roundtable on Sustainable Palm Oil) certification has moved from a nice-to-have to a near-mandatory credential for manufacturers that purchase, process, or incorporate palm oil and its derivatives into finished products. ISC Global offers comprehensive RSPO Supply Chain Certification (RSPO SCCS) consulting, guiding manufacturers in Vietnam and across Asia through every stage — from initial gap assessment to certificate issuance and long-term system maintenance.

What Is RSPO Certification?

RSPO is an international not-for-profit organisation that brings together stakeholders across the palm oil value chain — growers, mills, processors, traders, retailers, and civil society — to develop and implement credible global standards for sustainable palm oil. Companies that do not grow or mill palm oil themselves, but purchase, use, or process palm oil and its derivatives as an ingredient — such as food manufacturers, cosmetics producers, and oleochemical companies — need to comply with the RSPO Supply Chain Certification Standard (RSPO SCCS), which verifies that a company’s system for receiving, controlling, storing, using, and tracing palm oil-derived material meets internationally recognised requirements.

This is distinct from the RSPO Principles & Criteria (P&C) — most recently updated to the 2024 version, adopted at RSPO’s 21st General Assembly — which applies primarily to growers and mills further upstream in the supply chain.

The Four RSPO Supply Chain Models

Before building a certification roadmap, every manufacturer needs to select the supply chain model that fits its operations and budget:

• Identity Preserved (IP): Certified palm oil from a single identifiable source, kept physically separate throughout the supply chain.
• Segregated (SG): Certified palm oil from multiple certified sources, still kept physically separate from conventional palm oil.
• Mass Balance (MB): Certified and non-certified palm oil may be mixed during production, provided the total volume of certified output claimed never exceeds the volume of certified input purchased. This is typically the most practical starting point for food and consumer-goods manufacturers, balancing cost with credibility.
• RSPO Credits (Book & Claim): Companies purchase RSPO credits corresponding to their palm oil usage without requiring physical segregation of the material itself.

Choosing the right model up front — usually Mass Balance for manufacturers beginning their sustainability journey — helps control implementation cost while still meeting full RSPO SCCS requirements.

Our 4-Stage Consulting Approach

ISC Global structures every RSPO SCCS project around four clear stages:

1. Kick-off, Gap Assessment & Awareness Training

We begin with a formal kick-off meeting to align on project objectives, scope, and coordination mechanisms, followed by the client forming a dedicated RSPO team (management representative, coordinator, and department representatives from purchasing, production, quality, warehouse, accounting, and sales — a requirement under the standard). We then conduct an on-site gap analysis of the existing material control and traceability system against RSPO SCCS requirements, and deliver initial RSPO awareness training for relevant staff.

2. Documentation System Development

We help build and standardise the full documentation package: procedures for receiving, controlling, and tracing palm oil-derived material; supply chain model-specific policies (particularly Mass Balance volume declaration procedures); purchasing forms, control records, and traceability documentation. At this stage we also verify that the client’s palm oil suppliers hold a valid RSPO Supply Chain licence, a prerequisite for making any RSPO claim on finished products.

3. Implementation & Evidence Building

Once the documented system is issued, we guide hands-on implementation on the factory floor — warehouse, production, and quality control areas — supporting internal audits and corrective actions to ensure the system works in practice, not just on paper.

4. Certification Audit Support

We help prepare the complete evidence package and coordinate with an RSPO-accredited independent certification body throughout the formal audit, supporting the resolution of any non-conformities identified, through to certificate issuance.

A typical project — from initial assessment to certification — takes 3 to 6 months, depending on the maturity of the client’s existing documentation and the speed of internal coordination. The RSPO Supply Chain certificate is valid for 5 years, subject to annual surveillance audits to maintain validity — certification is a continuous commitment, not a one-time event.

Why RSPO Certification Matters for Exporters

• Market access: Many global FMCG brands and retailers now require 100% RSPO-certified palm oil across their supply chains — certification is often a prerequisite simply to be considered as a supplier.
• Regulatory alignment: Traceability and deforestation-related regulations such as the EU Deforestation Regulation (EUDR) continue to push importers toward supply chains that can demonstrate verifiable, third-party-audited traceability.
• Brand credibility: Certification provides tangible, internationally recognised evidence of a company’s sustainability commitments to consumers, investors, and trading partners.
• Operational discipline: The process of building an RSPO-compliant system typically improves internal material control, reduces waste, and strengthens traceability well beyond what certification alone requires.

Why Work With ISC Global?

ISC Global brings hands-on experience across a wide range of international management system and product certifications — including ISO 9001, ISO 14001, ISO 45001, GRS, OCS, EcoVadis, SEDEX SMETA, and ISCC EU/PLUS — giving our consulting team a practical understanding of both the technical requirements of RSPO SCCS and the operational realities of manufacturing environments. In Vietnam, we work alongside our representative partner Duc Luong Services and independent audit coordination partner STC VN Co., Ltd. (Staunchly Vietnam), forming an end-to-end support ecosystem — from system consulting to certification-body coordination — that helps manufacturers move through the RSPO journey efficiently and cost-effectively.

Get in Touch for a Free Consultation

If your company is evaluating or ready to begin its RSPO Supply Chain Certification journey, our consulting team is ready to help design the right roadmap for your operations.

ISC Global

Hotline: +84 933 096 426 – +84 868 591 260

Email: info@iscglobal.asia | van.pham@iscglobal.asia

Website: iscglobal.asia | iscglobal.edu.vn

Entering Australia is not a matter of obtaining a single “TGA certificate.” The Therapeutic Goods Administration is the Australian Government regulator, while the usual commercial objective is inclusion of a kind of medical device in the Australian Register of Therapeutic Goods (ARTG) through an eligible Australian Sponsor.

Vietnamese manufacturers may already hold ISO 13485 certification, FDA establishment registration, device listings, 510(k) clearances or EU certificates. Those assets can be valuable, but they must be mapped to the Australian legal manufacturer, device scope, risk class and conformity assessment route. A disciplined market-access project prevents the company from paying for a Sponsor, MDSAP audit or new testing before the evidence strategy is understood.

1. What the TGA regulates

The TGA regulates therapeutic goods in Australia, including medical devices and IVDs, and oversees how they are manufactured, supplied, advertised and monitored. Unless an exemption, exclusion or special pathway applies, a medical device generally needs an ARTG entry before lawful supply in Australia.

KEY DISTINCTION  The TGA is a regulator, not an ISO-style standard. ARTG inclusion, Manufacturer Evidence acceptance and a TGA Conformity Assessment Certificate are different regulatory outcomes and should not be marketed as interchangeable.

The first regulatory questions are therefore product-specific: Is the product a medical device under Australian law? What is its classification? How should models be grouped into a kind of device? What GMDN term applies? Which evidence route is acceptable? How many ARTG entries are likely to be required?

2. Why an Australian Sponsor is required

A foreign manufacturer normally needs an Australian-based legal entity that meets the statutory definition of Sponsor. The Sponsor submits applications through TGA Business Services, holds the ARTG entry, maintains access to evidence and has ongoing regulatory duties while the device is supplied.

• The manufacturer remains responsible for device design, production, classification, conformity assessment procedures and technical evidence.
• The Sponsor interfaces with the TGA and supports Australian post-market reporting, corrective action and recall obligations.
• The consulting team translates regulatory requirements into a controlled data and documentation programme; it does not replace the Sponsor or regulator.

Sponsor due diligence should cover fee structure, TGA portal governance, post-market service levels, access to technical documentation, change notification, transfer rights and termination. A low annual fee is not enough if the contract creates lock-in or unclear safety responsibilities.

3. Risk classification drives evidence and cost

Australia applies a risk-based classification framework. Non-IVD devices range from Class I to Class III, with specific categories such as Class I sterile and Class I measuring; IVDs use a separate system. Classification is based on the Australian rules and may differ from the US or EU result.

Intended purpose, invasiveness, duration of contact, implantability, active functions, software, materials and specific rule wording all matter. A product name such as “dental instrument” or “monitor” is not a sufficient classification basis.

4. The end-to-end ARTG pathway

1. Confirm the product is a medical device and determine whether ARTG inclusion is required.
2. Lock intended purpose, legal manufacturer, manufacturing sites, models, accessories and key claims.
3. Apply Australian classification rules and document the rule, rationale, assumptions and open questions.
4. Determine the GMDN term, kind-of-device grouping and expected ARTG entry count.
5. Select the conformity assessment evidence route, including any use of comparable overseas regulator evidence.
6. Remediate technical documentation and Australian documents against the Essential Principles.
7. Appoint the Australian Sponsor; submit Manufacturer Evidence where required, followed by the ARTG application.
8. Respond to application audits or queries and establish annual charge, UDI, vigilance and change-control processes.

5. What a submission-ready technical dossier should contain

The depth varies by device, but a coherent dossier should allow the Sponsor and TGA to trace every key claim to risk controls and objective evidence. Typical components include:

• Device description, variants, accessories, principles of operation, intended users and patient population.
• Essential Principles checklist with document-level evidence references.
• Lifecycle risk management, benefit-risk analysis and production/post-production information.
• Design verification and validation, including biocompatibility, electrical safety/EMC, software, cybersecurity, usability, sterilisation, packaging and shelf-life where relevant.
• Clinical evaluation and clinical evidence appropriate to intended purpose and risk.
• Labelling, instructions for use, Australian Declaration of Conformity, PMS plan, vigilance and recall procedures.

6. How ISO 13485, FDA, EU and MDSAP evidence may be used

ISO 13485 is a strong QMS foundation, but it is not ARTG inclusion. TGA guidance identifies circumstances in which an ISO 13485 certificate alone is not acceptable Manufacturer Evidence for non-IVD devices. Certificate scope, sites, legal entity and the issuing body must be reviewed rather than relying on the certificate title.

The TGA recognises a range of assessments and approvals from comparable overseas regulators and assessment bodies, including certain evidence from EU bodies, the US FDA, Health Canada, MDSAP auditing organisations, Japan and Singapore. Recognition is evidence-specific. FDA establishment registration and device listing are not product clearance or approval; 510(k), De Novo or PMA evidence must be distinguished and may need supporting QMS evidence.

EVIDENCE STRATEGY  Build an Evidence Acceptance Matrix before purchasing MDSAP, new testing or direct TGA conformity assessment. The matrix should map each device and site to QMS evidence, product authorisation, technical reports, clinical support, validity dates and identified gaps.

7. What changed in 2026

TGA fees from 1 July 2026

For non-IVD medical devices, the official 2026 schedule lists an ARTG application fee of AUD 651 for Class I categories, AUD 1,244 for Class IIa/IIb and AUD 1,603 for Class III. Annual charges are separate: AUD 121 for Class I other, AUD 879 for Class I sterile/measuring, AUD 1,305 for Class IIa/IIb and AUD 1,662 for Class III/AIMD. Application audit fees may be added.

UDI commenced with higher-risk devices

From 1 July 2026, in-scope Class IIb and Class III devices must meet Australian Unique Device Identification requirements, with lower-risk classes and IVDs following later phases. Manufacturers and Sponsors should plan identifiers, packaging levels, label control, AusUDID data and change-control rules; UDI is not merely a barcode artwork task.

8. ISC Global consulting methodology

ISC Global provides training, regulatory assessment, documentation consulting and compliance coordination for medical device manufacturers. The engagement begins with a controlled decision gate so that regulatory assumptions are validated before major third-party costs are triggered.

• Executive and cross-functional training on TGA, ARTG, Sponsor, Manufacturer Evidence, UDI and post-market duties.
• Product classification, GMDN and kind-of-device/ARTG grouping analysis.
• Gap assessment of ISO 13485, FDA/EU/MDSAP evidence and technical documentation.
• Drafting or review of the Essential Principles matrix, Australian Declaration of Conformity, labelling/IFU and PMS documentation within the agreed scope.
• Australian Sponsor and laboratory/assessment-body coordination after written approval of the third-party scope and quotation.
• Submission readiness, query tracking, audit support and regulatory handover for ongoing maintenance.

9. Deliverables that support internal ownership

Consulting should leave the manufacturer with a maintainable regulatory system, not only a set of meetings. Depending on scope, deliverables may include:

• Classification and ARTG Grouping Report with rule rationale and assumptions.
• Evidence Acceptance Matrix and prioritised gap register.
• Data Request List with owners, dates and expected evidence.
• Essential Principles Evidence Matrix and Australian document set.
• Testing and standards matrix, where relevant.
• Sponsor handover pack or submission-ready dossier under defined acceptance criteria.
• Query tracker, change log and close-out/maintenance plan.

10. Indicative timeline and budget logic

For a pilot product family with a reasonably mature dossier, classification, grouping and evidence-route assessment may target the first three to four weeks. Dossier remediation and submission readiness can require several additional weeks or months. New testing, MDSAP, clinical work, direct TGA conformity assessment and application audits can extend both timeline and budget.

The official ARTG fee is only one layer. A complete first-year budget may include consulting, Sponsor, TGA charges, testing, QMS/certification, translations, samples and post-market setup. It is better to approve these items at milestones than to treat every possible cost as mandatory on day one.

• Pilot with the product family that has the strongest technical and overseas market evidence.
• Confirm the expected ARTG entry count before obtaining a Sponsor quotation.
• Approve new testing only against a documented gap and current standard edition.
• Maintain a 10-15% contingency for queries, retesting, logistics and currency movement.
• Separate professional fees, government charges and third-party invoices in the commercial proposal.

11. Professional principles

ISC Global acts as an independent adviser connecting legal requirements with design, manufacturing, quality, clinical and market evidence. The consulting approach is based on four principles:

• Evidence-based conclusions: every classification, grouping and route states its basis and assumptions.
• Transparent cost gates: Sponsor, TGA, auditing organisation and laboratory costs require an approved scope and quotation.
• No misleading equivalence: ISO 13485 or FDA registration is never presented as TGA product approval.
• Clear role separation: the TGA, Sponsor, certification body, auditing organisation and laboratory remain independent decision-makers or service providers.

Frequently asked questions

Does the TGA issue one certificate for the whole company?

No. The usual market-authorisation outcome is ARTG inclusion for a kind of medical device, supported by appropriate conformity assessment evidence. A manufacturer may have multiple ARTG entries and evidence routes.

Can a Vietnamese manufacturer submit directly to the TGA?

A foreign manufacturer normally works through an eligible Australian-based Sponsor. The Sponsor submits and holds the ARTG entry while the manufacturer remains responsible for the device and supporting evidence.

Is ISO 13485 enough?

Not by itself in many non-IVD cases. It supports the QMS, but acceptable Manufacturer Evidence depends on device type, class and evidence route.

Does FDA registration count as Australian approval?

No. Establishment registration and device listing are not product clearance or approval. Any 510(k), De Novo or PMA evidence must be assessed for its Australian relevance and supporting QMS evidence.

How many products can be included in one ARTG entry?

The entry is based on a kind of medical device, not simply a catalogue. Models may be grouped only when they meet the applicable criteria; a grouping assessment is required.

Can a consultant guarantee an ARTG inclusion date?

No responsible consultant should guarantee the regulator’s decision or processing time. The consultancy can commit to defined deliverables and response support within its control.

Contact our business advisory team

Discuss your product classification, evidence route, dossier readiness and Australian market-access plan with our consulting team.

ISC Global

Hotline / Zalo: +84 933 096 426  |  +84 868 591 260

Email: info@iscglobal.asia  |  van.pham@iscglobal.asia

Website: iscglobal.asia  |  iscglobal.edu.vn

What Is RecyClass and Why Does It Matter to Vietnamese Manufacturers?

For plastic recyclers and manufacturers supplying European and international customers, simply describing a product as “recycled plastic” may no longer satisfy customer expectations.

Buyers increasingly expect evidence regarding the origin of plastic waste, pre-consumer versus post-consumer status, recycled-content claims, batch traceability, production records, input-output reconciliation and independent third-party verification.

RecyClass provides science-based methodologies, technical guidance and certification schemes designed to improve circularity and transparency across the plastics value chain.

Which RecyClass Certification Does Your Company Need?

Choosing the right scheme is the first critical decision.

Recycling Process Certification

This scheme is intended for plastic recyclers processing pre-consumer and/or post-consumer plastic waste into recycled plastic products. Typical candidates may include producers of recycled PET flakes and pellets, recycled HDPE, recycled LDPE/LLDPE, recycled PP and other eligible recycled polymer outputs.

Recycled Plastics Traceability Certification

This certification addresses traceability of recycled plastics further along the value chain and is relevant to companies using or handling recycled plastics beyond the recycling stage.

Recyclability Certification

For companies seeking to demonstrate the recyclability performance of plastic packaging, RecyClass operates separate recyclability certification schemes and methodologies.

EN 15343 and Recycled Plastic Traceability

A robust system should allow a company to demonstrate a logical evidence chain: Waste Supplier → Incoming Material → Receiving Record → Storage → Recycling Line → Production Batch → Recycled Output → Finished-Goods Warehouse → Sales Transaction.

The reverse trace should also work. Starting from a finished recycled product, the company should be able to trace relevant records back through production and ultimately to the recycled input.

Special Requirement for Recycling Sites: Module C

For Recycling Process Certification, applicants outside EU27+3 need to pay particular attention to Module C – Corporate Social Responsibility. A Vietnamese recycler should therefore include Module C in its readiness assessment from the beginning.

What About Food-Contact rPET?

Where recycled material is intended for food-contact applications, additional requirements may apply, including Module A where relevant. Companies should not market Module A as a standalone food-safety approval or as a substitute for EU food-contact regulatory compliance.

How Does the Certification Process Work?

A typical journey includes: Eligibility Review → Scope Definition → Certification Body Selection → Application & NDA → Document Preparation → On-site Audit → Corrective Actions, if applicable → Certification Decision → Renewal.

How Much Does RecyClass Certification Cost?

There is no single audit price applicable to every factory. An accurate quotation should normally consider the number of sites, polymers, product families, recycled-content variations, production lines, product codes/references, output variability, applicable modules and auditor travel requirements.

What Should Be Prepared Before the Audit?

ISC Global recommends building readiness around five pillars: certification scope; traceability; material flow and records; procedures and responsibilities; and internal verification.

How ISC Global Supports Your RecyClass Journey

Our consulting approach may include Initial Gap Assessment, Certification Scope Mapping, EN 15343 & RecyClass Training, Documentation Development, Traceability & Material-Flow Exercises, Module C / Module A Readiness, Internal Audit & Pre-assessment and Certification Support.

ISC Global acts as a training and consulting partner. The final certification decision remains with the competent third-party Certification Body.

Start With a RecyClass Readiness Assessment

If your factory produces or uses recycled plastics and is receiving RecyClass, EN 15343 or recycled-content requirements from European customers, the most efficient first step is to determine the correct certification route and assess your existing evidence.

Contact for Business Consulting

ISC Global
Hotline / Zalo: +84 933 096 426 – +84 868 591 260
Email: info@iscglobal.asia | van.pham@iscglobal.asia
Website: iscglobal.asia | iscglobal.edu.vn

A credible GRS programme connects certified inputs, transaction documents, physical or documentary traceability, volume reconciliation, responsible production controls and accurate claims. ISC Global helps manufacturers implement this system through online consulting plus on-site verification, while trading companies can receive a streamlined online programme focused on contracts, invoices, Scope Certificates and Transaction Certificates.

What is the Global Recycled Standard?

The Global Recycled Standard (GRS) is an international, voluntary, full-product standard owned by Textile Exchange. It establishes requirements for third-party certification of recycled content and chain of custody and includes social, environmental and chemical requirements for relevant processing operations. It is used by recyclers, processors, manufacturers, traders and other supply-chain organisations seeking independently verified recycled-material claims.

GRS 5.0 became effective on 1 July 2026 and may be used immediately. It becomes mandatory for audits conducted from 31 December 2026. The update is targeted rather than a full redesign: it strengthens reclaimed-material data tracking, introduces the revised Reclaimed Material Declaration Form (RMDF), and clarifies the role of the first certified entity in the recycling supply chain.

The 20% and 50% recycled-content thresholds

GRS can be used as a business-to-business tool for products containing at least 20% recycled material. Product-specific, consumer-facing GRS labelling requires at least 50% recycled content and compliance with the applicable claims and logo policy. Neither threshold provides automatic permission to use the logo: the certified scope, transaction evidence and approval requirements still apply.

GRS does not certify product quality or replace legal compliance, product safety testing, customer Restricted Substance Lists or market-specific environmental-claim laws. Claims must be written narrowly and supported by the exact certified attribute.

Who needs GRS certification consulting?

• Manufacturers of yarn, fabric, apparel, accessories, plastics, packaging and other intermediate or finished products containing recycled material.
• Processors involved in dyeing, printing, coating, laminating, finishing, assembly or subcontracted production within a GRS product flow.
• Trading, import-export or offshore entities that buy, own, invoice or sell GRS products, even when goods ship directly from the factory to the customer.
• Existing certificate holders adding products, processes, sites, warehouses or subcontractors, or preparing for recertification.
• Recyclers and primary processors preparing for GRS 5.0, the revised RMDF and the Materials Matter transition.

Our consulting methodology

1. Scope and transaction mapping

We review legal entities, sites, products, recycled materials, processes, warehouses, subcontractors and commercial flows. The resulting scope map and transaction map identify who buys, sells, pays, owns, processes and ships the product, and whose name appears on contracts, invoices, transport documents, Scope Certificates and Transaction Certificates.

2. Clause-based gap assessment

Each gap is linked to the applicable requirement, risk, owner, required document, operating evidence and target date. The assessment is built around the client’s actual material and data flow rather than a generic checklist.

3. Practical management-system documentation

• GRS system plan, scope register and responsibility matrix.
• Supplier approval and validation of incoming Scope Certificates and Transaction Certificates.
• Receiving, identification, segregation, lot traceability, production, subcontracting and shipment controls.
• Bills of material, recycled-content calculations, process-loss logic and volume reconciliation.
• Social, health and safety, environmental and chemical-management procedures appropriate to the scope.
• Claims, logo, sales-document and outgoing Transaction Certificate controls.

4. Role-based training

Management, the GRS team, purchasing, warehouse, production, quality, EHS/HR, sales, logistics and trading personnel receive role-specific training. Sessions use real or simulated documents so participants can explain their controls and retrieve evidence during an audit interview.

5. System implementation and evidence review

We review completed forms and operating records, run backward and forward traceability tests, test volume reconciliation, and verify that written procedures match actual practices. Issues are converted into corrective actions with clear owners and evidence requirements.

6. Mock audit and certification support

The readiness review covers documents, interviews and the site where applicable. We support application review, audit preparation and corrective-action responses. Certification findings and decisions remain entirely independent and are controlled by the selected approved Certification Body.

Consulting model for manufacturing sites: online plus on-site

Online workshops are efficient for document development, data review and action tracking. On-site work is essential when consultants need to observe receiving, warehouse identification, production flow, rework, waste, chemical storage, worker safety, environmental controls and staff interviews. A medium-sized factory programme may use an initial site review and a later mock audit, with remote support in between.

• Walk-through from receiving to shipment, including off-site storage and subcontracting interfaces.
• Sampling of lots, labels, production orders, material issues, output records and inventory status.
• Review of social, occupational health and safety, environmental and chemical controls at the point of use.
• Live traceability and mass-balance exercises with process owners.
• Interview coaching focused on understanding, not scripted answers.

Consulting model for trading companies: streamlined online delivery

A trading company with electronic records and no physical handling can usually complete consulting and training online. The system focuses on legal identity, ownership, documentary chain of custody, certified quantities and claims. The Certification Body determines whether and how the certification audit is conducted.

• Order-to-invoice and direct-shipment mapping.
• Supplier/customer approval and Scope Certificate monitoring.
• Incoming and outgoing Transaction Certificate register, quantity allocation and status tracking.
• Claims and logo approval workflow for websites, quotations and sales documents.
• One sample transaction exercise and one complete traceability test.
• Remote mock interview and nonconformity-response support.

Key technical controls we test

Scope Certificates and Transaction Certificates

A Scope Certificate confirms that an organisation is qualified for the listed products and processes; it does not prove that every shipment is certified. A Transaction Certificate supports the certified status of specific products and transaction details. Textile Exchange states that certified products must be accompanied by the required TC evidence.

Volume reconciliation

Certified inputs, outputs, opening and closing inventory, process losses, rejects, rework and sales must reconcile within a defined period. Where recycled and virgin materials have different loss rates, the mass-balance method must account for the difference. Traders also need quantity allocation controls so the same certified volume is not sold twice.

Social, environmental and chemical management

Manufacturing sites need assigned responsibilities, policies, legal-compliance tracking, records and training. Chemical controls include an accurate inventory, supplier information, Safety Data Sheets and evidence that chemical inputs used for GRS production meet the applicable acceptance criteria. GRS chemical controls do not replace final-product RSL compliance or legal testing obligations.

Reclaimed-material data under GRS 5.0

The first certified entity in the recycling supply chain has enhanced responsibilities for supplier authorisation records, supplier agreements, revised RMDF collection, incoming-material inspection and outgoing TCs. Even downstream organisations should understand the change because it affects the reliability and continuity of upstream evidence.

Typical deliverables

• Confirmed scope and transaction map.
• Customised management-system manual, procedures, forms and registers.
• Training materials and attendance/competence evidence.
• Supplier, Scope Certificate and Transaction Certificate verification tools.
• Traceability-test and volume-reconciliation workbooks.
• Gap register, mock-audit report, corrective-action tracker and certification-audit support.

Timing and commercial structure

A 14-18 week implementation window may be suitable for a medium-sized, responsive project with available certified inputs and committed process owners. It is a planning estimate for consulting readiness, not a guaranteed certification date. Certification Body scheduling, audit duration, nonconformity closure and certificate issuance follow a separate independent process.

Consulting and training fees are scoped by legal entities, sites, products, processes, headcount, subcontractors, languages, on-site days and evidence maturity. Third-party audit and certification fees are quoted and paid separately under the relevant arrangement with the certification service provider or Certification Body.

Frequently asked questions

Can a two-person trading company obtain GRS certification?

Yes, company size is not the determining factor. Responsibilities, document control, transaction evidence and staff competence must be clear. The applicable scope and any exemption should be confirmed with the Certification Body.

Can all consulting be delivered online?

Trading-company consulting can often be delivered online. Manufacturing projects normally benefit from on-site reviews. The audit method is independently determined by the Certification Body.

Does a valid supplier Scope Certificate make our shipment certified?

No. The product must be within the supplier’s scope and the transaction must be supported by the required Transaction Certificate and consistent commercial documents.

Does GRS certification allow us to use the logo on every product?

No. Product-specific labelling requires at least 50% recycled content, an eligible certified supply chain and compliance with the applicable claims/logo approval rules.

Does consulting guarantee certification?

No. Consulting improves readiness and supports corrective action. Audit conclusions and certification decisions remain with the independent approved Certification Body.

Contact our enterprise advisory team

Discuss your certification scope, recycled-material flow and a suitable online/on-site implementation model with our team.

ISC Global

Hotline/Zalo: +84 933 096 426 – +84 868 591 260  |  Email: info@iscglobal.asia; van.pham@iscglobal.asia  |  Website: iscglobal.asia; iscglobal.edu.vn

In the food, beverage, pharmaceutical, and packaging manufacturing industries, contamination risks stem not only from raw ingredients but also from operational auxiliary chemicals, such as equipment lubricants, cleaning agents, and water treatment additives.

To control the risk of accidental chemical contamination, NSF International established the NSF Nonfood Compounds Registration Program. Recognized as a global benchmark, this program evaluates and confirms the safety of industrial chemicals and auxiliary materials used in and around food processing areas.

1. WHAT IS NSF NONFOOD COMPOUNDS?

NSF Nonfood Compounds is an independent registration program for nonfood compounds and auxiliary materials—chemicals used within the infrastructure or equipment of food processing facilities that are not intended to be ingested as food ingredients.

• Origin: The program inherited and expanded upon the chemical review and authorization system previously managed by the United States Department of Agriculture (USDA).
• Primary Objective: To ensure that when these compounds are used for maintenance, cleaning, sanitizing, or water treatment, they do not compromise food safety or cause toxic chemical contamination in the production line.

2. WHY IS NSF NONFOOD COMPOUNDS INCREASINGLY IMPORTANT?

Global food safety schemes such as HACCP, ISO 22000, BRCGS, FSSC 22000, and IFS mandate strict contamination control measures across supply chains.

• Contamination Risk Management: Accidental leakage of gearbox lubricants or chemical residues from surface sanitizers can result in costly product recalls and severe reputational damage.
• Auditor and Customer Requirements: GFSI-recognized standards require facilities to demonstrate that all chemicals, lubricants, and cleaners used in processing areas comply with established safety criteria (such as NSF Nonfood Registration).
• Transparent Verification: The system allows food manufacturers and auditors to easily verify supplier compliance through a centralized global database.

3. SCOPE AND CATEGORY CODES OF NSF NONFOOD

NSF classifies nonfood compounds into distinct Category Codes based on their end-use and potential level of exposure to food products:

A. Technical Lubricants

• NSF H1: Lubricants formulated for incidental food contact (where unintended contact may occur due to splashes, leaks, or mechanical discharge). Trace concentrations in food must not exceed 10 ppm (10 mg/kg).
• NSF H2: Lubricants used on equipment in areas where there is no possibility of food contact.
• NSF H3 / HT1: Soluble oils/anti-rust coatings for tools before cleaning, or heat transfer fluids used in processing areas.

B. Cleaners & Sanitizers

• Codes A1 – A8: General surface cleaners, industrial degreasers, carbon removers, and glass cleaners.
• Codes D1 – D2: Sanitizers and disinfectants for food-contact and non-food-contact surfaces.

C. Water Treatment Products

• Codes G1 – G7: Boiler water treatment chemicals, steam line treatments, and cooling water additives used in food plants.

4. WHO IS CONSIDERED A “PRODUCER” / REGISTRANT?

Entities participating in the NSF Nonfood Compounds Registration Program generally include:

1. Original Chemical Manufacturers: Companies that formulate, blend, and produce industrial chemical products.
2. Rebranders & Distributors: Businesses that purchase formulated chemicals and market them under their own private labels.
3. Ingredient Suppliers: Manufacturers of raw ingredients or additives that register under codes such as HX-1 / HX-2 for supply to lubricant blenders.

5. EVALUATION AND REGISTRATION PROCESS

To achieve NSF Nonfood Registration, a product undergoes a rigorous review process:

1. Formulation Review: NSF toxicologists evaluate the full formulation details (CAS numbers and percentage compositions) against applicable US FDA regulations (e.g., 21 CFR 178.3570 for H1 lubricants).
2. Label & Use Review: NSF reviews product labels, technical data sheets, and usage instructions to ensure clear, accurate safety claims.
3. Issuance of Registration Letter: Upon approval, NSF issues an official Registration Letter containing a unique NSF Registration Number and assigned Category Code.
4. Listing on the NSF White Book: The registered product is listed in the publicly accessible online database, NSF White Book (nsfwhitebook.org), utilized worldwide by procurement teams and food safety auditors.

6. COMPARISON: NSF NONFOOD REGISTRATION VS. NSF/ANSI STANDARDS (NSF 51, 60, 61)

It is important to distinguish between chemical registration and equipment/water certification:

7. KEY CONSIDERATIONS FOR MANUFACTURERS & EXPORTERS

Chemical manufacturers, lubricant blenders, and suppliers targeting the food and beverage industry should consider the following steps:

• Select the Correct Category Code: Match the formulation and intended use with the appropriate NSF category (e.g., H1 vs. H2, D1 vs. D2).
• Ingredient Compliance Check: Ensure all raw materials meet FDA positive lists or recognized toxicology limits.
• Label Compliance: Ensure the NSF logo, Registration Number, and Category Code are accurately presented on packaging post-approval.
• Maintain Online Listing: Keep registrations active on the NSF White Book for verification during customer supplier audits.

8. CONSULTING AND COMPLIANCE SERVICES AT ISC GLOBAL

Demonstrating compliance through NSF Nonfood Compounds Registration provides a distinct competitive advantage when supplying chemicals to international food, beverage, and pharmaceutical supply chains.

ISC Global provides end-to-end consulting and technical support for NSF Nonfood compliance:

• Formulation feasibility assessments against NSF and US FDA regulatory requirements.
• Category Code determination and gap analysis for chemical product lines.
• Compilation of technical dossiers and liaison with NSF International.
• Guidance on product labeling, Technical Data Sheets (TDS), and Safety Data Sheets (SDS) alignment.

Proactively securing NSF Nonfood Compounds Registration enables companies to meet international supply chain requirements, enhance market access, and demonstrate high standards of product safety.

Contact us to download the bilingual English-Vietnamese PDF standard: from only $50

On the path toward integration and export, correctly understanding and applying international standards is essential. Yet language and technical terminology often pose real barriers. We are pleased to introduce our bilingual (English – Vietnamese) standards documentation service, translated by our own team of certification consultants.

What We Provide

• A clause-by-clause bilingual comparison, easy to consult and file.

• Professional Vietnamese translation in correct technical terminology, ready to use.

• Interpretation notes and application guidance from hands-on experts.

• Fast delivery in editable, easy-to-store PDF/Word format.

Standards Covered

ISO management systems (9001, 14001, 45001, 37001); sustainability certifications (ISCC, FSC, VFCS/PEFC); textiles and recycled materials (GRS, OCS, OEKO-TEX); social responsibility and ESG (SMETA, EcoVadis, Fairtrade), and many other industry standards upon request.

Why Choose Us

Our documents are translated by professionals who directly consult on and audit certifications, so the translation is accurate not only in language but also in real-world application — saving you time and reducing errors when preparing documentation.

Pricing

From only USD 50 per document, depending on length and complexity. Please send us the standard name to receive a free, accurate quotation.

How to Order

1. Contact us with the name of the standard you need.

2. Receive a quotation and delivery time.

3. Make payment and receive your document by email.

Payment

Bank transfer via QR code (provided with the quotation), or via PayPal: ducluongservices@gmail.com.

We look forward to accompanying you on your certification journey.

Best regards,

CONTACT INFORMATION

Hotline: +84 933096426 – +84 868 591 260

Email:

• info@iscglobal.asia
• van.pham@iscglobal.asia

Website:

• https://iscglobal.asia/
• https://iscglobal.edu.vn/

Australia’s healthcare and medical device market is widely recognized as one of the most advanced, transparent, and high-value sectors in the Asia-Pacific region. However, this immense potential is matched by stringent technical barriers. To legally import, market, and distribute medical devices, pharmaceuticals, or health supplements in Australia, businesses must successfully navigate the rigorous approval process of the TGA.

The following article provides a comprehensive overview of the TGA, the major challenges businesses face, and our expert end-to-end consulting solutions.

1. WHAT IS THE TGA AND THE ARTG?

The TGA (Therapeutic Goods Administration) is Australia’s government authority responsible for regulating, evaluating, licensing, and monitoring therapeutic goods. Acting as the ultimate regulatory gatekeeper, the TGA ensures that all medical products supplied in Australia meet the highest standards of safety, quality, and performance.

Every product successfully approved by the TGA must be entered into the ARTG (Australian Register of Therapeutic Goods)—Australia’s national public database. Without an active ARTG entry, importing, advertising, or supplying your product in Australia is strictly illegal.

The TGA’s Regulatory Scope Includes:

• Medical Devices: From consumables (face masks, surgical drapes, syringes) to in-vitro diagnostics (IVDs), software as a medical device (SaMD), and active implantables.
• Medicines: Prescription drugs, over-the-counter (OTC) medicines, and vaccines.
• Complementary Medicines: Vitamins, minerals, herbal extracts, and dietary supplements.
• Biologicals: Human blood, tissues, and cell-based products.

2. RISK-BASED CLASSIFICATION OF MEDICAL DEVICES UNDER TGA

Unlike other jurisdictions, the TGA applies a highly detailed risk-classification framework that directly determines the application pathway, timeline, and cost. Medical devices are categorized into distinct risk classes:

• Class I (Low Risk): E.g., standard surgical face masks, bandages, non-invasive manual surgical instruments. Typically subject to a self-declaration pathway with fast processing times.
• Class IIa (Low-Medium Risk): E.g., hypodermic needles, surgical gloves, blood pressure monitors. Requires moderate technical file assessment.
• Class IIb (Medium-High Risk): E.g., ventilators, infusion pumps, condoms. Requires strict evaluation of clinical evidence and quality management systems.
• Class III & AIMD (High Risk & Active Implantable Devices): E.g., heart valves, pacemakers. Subject to the highest level of scrutiny, requiring extensive clinical data and direct TGA conformity assessment.

3. KEY BENEFITS OF OBTAINING TGA CERTIFICATION

• Gateway to Oceania: A mandatory prerequisite to participate in procurement tenders for both public and private hospital networks in Australia.
• Global Benchmark of Quality: The TGA is globally recognized for stringency comparable to the US FDA and European CE marking. Achieving TGA clearance serves as an ultimate testament to product quality and safety.
• Leverage for International Expansion: Many countries across Southeast Asia and Latin America streamline or expedite local registration pathways for products that already hold TGA or FDA approvals.

4. THE THREE MAJOR CHALLENGES FOR OVERSEAS MANUFACTURERS

Foreign manufacturers often incur heavy financial losses and delays due to the following hurdles:

1. The Australian Sponsor Requirement: Australian law mandates that only a local legal entity (an Australian Sponsor) can submit applications and hold the ARTG inclusion on behalf of overseas manufacturers. Finding a reliable, compliant Sponsor is a critical bottleneck.
2. Complex Technical Files and Quality Systems: The TGA imposes rigorous demands on Quality Management Systems (QMS). Even if a manufacturer holds ISO 13485 or CE certification, the TGA maintains unique, specific requirements regarding clinical evidence and safety warnings.
3. Strict Financials and Regulatory Pitfalls: A misclassified device or improperly filled application can result in immediate rejection, the forfeiture of non-refundable government fees (ranging from thousands to tens of thousands of AUD), and restarting the process from scratch.

5. ISC GLOBAL’S COMPREHENSIVE TGA CONSULTING SOLUTIONS

To help manufacturers overcome these complexities, ISC Global provides an end-to-end TGA consulting solution covering the entire product lifecycle across four core phases:

Phase 1: Assessment, Review & Strategic Planning

• Review product technical specifications and perform precise risk classification in accordance with Australian regulations.
• Conduct a Gap Analysis comparing existing documentation (ISO 13485, CE, FDA, clinical test reports) against TGA requirements.
• Provide a detailed cost and timeline estimate, outlining official government fees (TGA Fees & Charges) to ensure transparent financial planning.

Phase 2: Technical File Preparation & Standardization

• Guide and directly assist in drafting technical documentation, including the Declaration of Conformity, Risk Management Report, and Clinical Evaluation Reports.
• Review and standardize labeling and Instructions for Use (IFU) to ensure strict adherence to Australian medical warning guidelines.
• Advise on strengthening your QMS to prepare for potential regulatory audits.

Phase 3: Sponsor Connection & Dossier Submission

• Sponsor Solutions: Assist in connecting manufacturers with reputable, trusted Australian Sponsors, protecting your commercial interests and technical data confidentiality.
• Support the Sponsor in submitting and verifying Manufacturer Evidence.
• Manage the formal electronic submission process via the TGA’s electronic Business Services (eBS) portal.

Phase 4: Regulatory Liaison & Post-Market Maintenance

• Act as the direct liaison to handle and resolve any Requests for Information (RFIs) or inquiries from TGA evaluators within statutory timeframes.
• Successfully deliver the final ARTG certificate.
• Advise on post-market surveillance obligations and ongoing annual maintenance duties.

6. WHY PARTNER WITH ISC GLOBAL?

With deep expertise in international standards (ESG, ISO, risk management, and compliance), ISC Global approaches TGA certification not merely as a paperwork exercise, but as a strategic optimization of your core manufacturing process:

• Deep Technical Expertise: Our specialists understand intricate regulations, minimizing the risk of application rejections.
• Transparency & Accountability: Committed roadmaps with no hidden costs, supporting you all the way until your products successfully enter the Australian market.
• Global Network: Fast and dependable connections with certified Australian Sponsors.

Ready to Conquer the Billion-Dollar Australian Market? Do not let technical barriers slow down your commercial expansion. Contact ISC Global today to receive a complimentary preliminary risk-classification assessment!

Contact us to download the bilingual English-Vietnamese PDF standard: from only $50

On the path toward integration and export, correctly understanding and applying international standards is essential. Yet language and technical terminology often pose real barriers. We are pleased to introduce our bilingual (English – Vietnamese) standards documentation service, translated by our own team of certification consultants.

What We Provide

• A clause-by-clause bilingual comparison, easy to consult and file.

• Professional Vietnamese translation in correct technical terminology, ready to use.

• Interpretation notes and application guidance from hands-on experts.

• Fast delivery in editable, easy-to-store PDF/Word format.

Standards Covered

ISO management systems (9001, 14001, 45001, 37001); sustainability certifications (ISCC, FSC, VFCS/PEFC); textiles and recycled materials (GRS, OCS, OEKO-TEX); social responsibility and ESG (SMETA, EcoVadis, Fairtrade), and many other industry standards upon request.

Why Choose Us

Our documents are translated by professionals who directly consult on and audit certifications, so the translation is accurate not only in language but also in real-world application — saving you time and reducing errors when preparing documentation.

Pricing

From only USD 50 per document, depending on length and complexity. Please send us the standard name to receive a free, accurate quotation.

How to Order

1. Contact us with the name of the standard you need.

2. Receive a quotation and delivery time.

3. Make payment and receive your document by email.

Payment

Bank transfer via QR code (provided with the quotation), or via PayPal: ducluongservices@gmail.com.

We look forward to accompanying you on your certification journey.

Best regards,

CONTACT INFORMATION

Hotline: +84 933096426 – +84 868 591 260

Email:

• info@iscglobal.asia
• van.pham@iscglobal.asia

Website:

• https://iscglobal.asia/
• https://iscglobal.edu.vn/

Vietnam has become one of the world’s leading production hubs for hard-surface flooring — from engineered and laminate wood flooring to vinyl (LVT/SPC), quartz stone flooring, rubber flooring and flooring adhesives. As international buyers, green-building projects and retail chains increasingly demand independently verified low-emission products, FloorScore® certification has moved from a “nice-to-have” to a de facto market-entry requirement for many export contracts into North America and Europe.

This guide, prepared by ISC Global — an international standards and ESG certification consulting firm based in Ho Chi Minh City, Vietnam — explains what FloorScore® certification actually verifies, how the certification process works, and what Vietnamese manufacturers need to prepare, based on the current official programme documentation.

1. What Is FloorScore® Certification?

FloorScore® is the most widely recognised Indoor Air Quality (IAQ) certification programme for hard-surface flooring materials, flooring adhesives and underlayments. It was developed by SCS Global Services in conjunction with the Resilient Floor Covering Institute (RFCI), a leading US flooring-industry association. SCS Global Services is currently the programme’s exclusive certification body.

Unlike self-declared “eco-friendly” marketing claims, FloorScore® is a third-party, independently verified certification based on scientific emissions testing combined with an on-site factory audit — which is precisely why it carries commercial weight with sourcing and procurement teams that self-declared claims cannot match.

2. The Technical Basis: What Does FloorScore® Actually Measure?

Certified products must demonstrate compliance with volatile organic compound (VOC) emission limits under two key documents:

• SCS-105 Indoor Air Quality Standard, Version 4.2 (December 2023) — the current certification standard, with Appendix 1 setting out FloorScore®-specific requirements.
• CDPH/EHLB Standard Method V1.2 (January 2017), commonly known as California Section 01350 — the chamber-based test method modelling classroom and private-office exposure scenarios.

Under the current standard, the programme evaluates 35 individual VOCs, including formaldehyde. Certification is not based on a single test result alone; it also requires formulation review, factory document control, an on-site audit, representative “worst-case” sample selection, and independent technical review before a certification decision is issued.

3. Why FloorScore® Matters for Manufacturers Right Now

Vietnam’s wood and wood-product export sector has continued to post strong growth, with wood and wood-product exports reaching roughly USD 15.5 billion over the first eleven months of a recent reporting year — while global buyers increasingly favour “greener,” independently verified building materials over commodity products. Industry research on the regional laminate flooring market also points to a marked rise in environmental awareness among buyers over the past several years, with manufacturers holding low-VOC or sustainability certifications reporting notably faster sales growth than uncertified competitors. At the same time, Vietnam’s own green building materials market is projected to expand at a high single-digit compound annual growth rate through the next decade, driven by urbanisation and the country’s Net Zero policy direction.

For Vietnamese manufacturers, this translates into three concrete commercial advantages from holding FloorScore® certification:

• De facto entry requirement for many North American and European flooring distributors and retail chains
• Green-building credit contribution: FloorScore®-certified products are recognised under major international green-building rating systems, including LEED v4.1, the WELL Building Standard, BREEAM, CHPS and Green Globes — making certified products easier to specify into green construction projects
• Durable brand asset: certified products are listed in the public SCS Green Products Guide, building long-term trust with B2B buyers and specifiers

4. Product Scope

FloorScore® applies to most categories of hard-surface flooring and related products, including:

• Laminate and engineered wood flooring
• Vinyl sheet/roll flooring, LVT, SPC and WPC flooring
• Quartz stone flooring
• Rubber flooring and linoleum
• Hard-surface carpet tile meeting the applicable criteria
• Flooring adhesives and underlayments

5. What FloorScore® Confirms — and What It Does Not

This is a frequent point of confusion for first-time applicants: FloorScore® only evaluates VOC emissions and manufacturing consistency related to emissions. It does not evaluate mechanical durability, slip resistance, fire resistance, colour fastness or water resistance. Manufacturers needing to substantiate those performance claims must pursue separate testing under the relevant standards (for example, ASTM methods for slip or abrasion resistance).

6. The Certification Process, Step by Step

According to SCS’s published guidance, the average certification cycle takes about three months from a signed work order to a final decision, with VOC testing itself typically taking 3–4 weeks. In practice, total project duration — from kick-off to decision — commonly runs 12–14 weeks, depending on documentation readiness and auditor/laboratory scheduling.

7. What Manufacturers Need to Prepare

• A complete list of models/SKUs intended for the certificate, including trade names, thickness, dimensions and target markets
• Formulation/construction data, Bill of Materials, and SDS/TDS documentation for raw materials and coatings
• A manufacturing process flow diagram and identification of VOC-relevant process control points
• A Quality Control Plan or equivalent documentation covering traceability, change control and nonconforming-product handling
• Corporate and OEM-relationship documentation where a brand owner and contract manufacturer are separate legal entities

8. The Role of a Local Consulting and Coordination Partner

Given the complexity of formulation review, worst-case sample selection and factory-level documentation requirements, most first-time applicants benefit substantially from working with an experienced local consulting partner. A well-structured engagement typically separates two distinct roles to preserve the programme’s impartiality principle:

• A technical consulting partner (in Vietnam, typically an ISO/ESG consulting firm) that delivers training, performs the gap assessment, and helps build the technical dossier and Quality Control Plan
• A local contracting and coordination partner that signs the domestic coordination contract, issues local invoices, and manages communication and scheduling with the certification body and testing laboratory

Crucially, neither party performs the audit, sampling, testing, or certification decision — those functions remain the independent authority of SCS Global Services and the accepted testing laboratory. This separation of roles is what protects the credibility of the resulting certificate in the eyes of international buyers.

9. Frequently Asked Questions

Is FloorScore® a legal requirement in Vietnam? No. FloorScore® is a voluntary, market-driven certification rather than a Vietnamese regulatory requirement. However, it is frequently a contractual requirement imposed by North American and European importers and distributors.

How long does FloorScore® certification remain valid? Certification must be maintained on the programme’s ongoing cycle, which includes periodic desk reviews and may require re-testing as determined by SCS.

Can a brand owner and a contract manufacturer (OEM) share one certificate? SCS will confirm the appropriate certification structure based on the actual contractual and ownership relationship between the brand owner and the manufacturing site.

What is the typical cost structure for FloorScore® certification? Costs generally fall into three categories: (i) technical consulting and training fees, (ii) local contracting/coordination fees, and (iii) fees paid directly to the certification body, auditor and testing laboratory under their own official quotations.

Get Expert Support for FloorScore® Certification in Vietnam

ISC Global supports Vietnamese flooring manufacturers throughout the full FloorScore® certification journey — from staff training and gap assessment to technical dossier preparation and coordination support with the certification body.

Contact us for business consultation:

Hotline: +84 933 096 426 – +84 868 591 260

Email: info@iscglobal.asia | van.pham@iscglobal.asia

Website: iscglobal.asia | iscglobal.edu.vn

As Japanese and European biomass buyers tighten sustainability, traceability and greenhouse-gas (GHG) reporting requirements, Green Gold Label (GGL) certification has become one of the key market-access credentials for producers of wood pellets and wood chips. This article, prepared by the ESG and sustainable supply chain consulting team at ISC Global, explains what GGL certification involves, why it matters for exporters, and how a structured consulting approach can shorten the path to certification.

What Is Green Gold Label (GGL)?

Green Gold Label is an international certification programme for sustainable biomass, independently operated since 2002. Unlike forest-management certifications such as FSC or PEFC, GGL is built around tracking and verifying biomass across the entire supply chain — from wood origin and processing, through trade and transport, to final use in power generation — via a Chain of Custody system, independent third-party audits, and the GGLedger digital tracking platform.

The programme’s core standards relevant to most Vietnamese wood pellet and wood chip producers include:

• GGLS1 – Chain of Custody criteria
• GGLS4 – Transaction and Product Certificate requirements
• GGLS5 – Forest Management criteria, used when deeper source verification is required
• Market-specific modules, notably FIT/FIP for Japan and SDE++ for the Netherlands, which set additional requirements tied to each country’s renewable-energy support scheme

Why Exporters Need GGL Certification

For producers already exporting to Japan, or planning to enter the Japanese or Dutch biomass markets, GGL certification delivers concrete commercial value:

• Meets mandatory buyer/power-plant requirements for biomass supplied under Japan’s FIT/FIP scheme or the Netherlands’ SDE++ scheme — without recognised certification, long-term supply contracts with these buyers are difficult to secure.
• Strengthens competitiveness as an increasing share of biomass contracts now require independently verified sustainability evidence as a baseline condition, not a differentiator.
• Standardises GHG emissions data using an internationally recognised methodology, supporting both buyer reporting requirements and the producer’s own ESG disclosures.
• Builds on existing certifications: producers that already hold FSC CoC, PEFC CoC or SBP certification typically shorten GGL implementation significantly, since much of the supplier control structure, claim management and transaction records can be reused once the Certification Body confirms the applicable scope.

The GGL Certification Process

ISC Global structures GGL implementation into six phases, designed to move efficiently while ensuring the system is genuinely ready before the formal audit:

1. Scope confirmation – clarifying the market module (FIT/FIP, SDE++), biomass category, the company’s role in the GGL chain, and specific buyer requirements.
2. Gap assessment – an on-site review comparing existing FSC/PEFC/SBP systems against GGL requirements, identifying what needs to be added.
3. Awareness training – equipping purchasing, production, warehouse, export and accounting teams with practical knowledge of GGLS1, GGLS4, GGLS5 and GHG data requirements.
4. System development – drafting procedures, forms, mass-balance and conversion-factor controls, and a GHG data workbook.
5. Trial operation and pre-audit – running the system through at least one real operating cycle, conducting an internal audit, and closing gaps before inviting the Certification Body.
6. Certification audit support – supporting the company throughout the independent audit and helping prepare responses to any findings raised by the Certification Body.

Typical timelines to the formal audit run 10–14 weeks, depending on data readiness and the maturity of existing chain-of-custody systems.

What Certification Costs Typically Include

Producers new to GGL often conflate consulting fees with certification fees. In practice, a complete GGL project involves three distinct cost components:

1. Consulting, training and system-development fees — usually a fixed, quoted package based on scope (number of sites, product lines, and market modules).
2. Independent Certification Body (CB) audit fees — quoted separately by the CB based on actual audit duration, and only committed after client approval.
3. GGL Participant fees — charged based on role (trader, producer) and the actual biomass volume entered into the GGL chain. This is a variable, volume-linked fee that should be estimated against realistic contracted volumes, not nameplate production capacity, to avoid budget surprises.

Why Work With ISC Global

ISC Global is a specialist ESG, management systems and sustainable supply chain consulting and training firm, with hands-on experience across FSC, PEFC, SBP, ISCC EU/PLUS and GGL for biomass and timber-based supply chains. Our approach is built on three principles:

• Practical, site-specific system design rather than generic templates, informed by direct assessment of each producer’s actual operations.
• Integration with existing certifications wherever possible, to reduce duplicated effort and shorten time to certification.
• Continuous monitoring of GGL programme updates — standard versions, documentation changes and Participant Fee schedules — to ensure consulting deliverables reflect current requirements at the time of audit.
• Strict independence: ISC Global does not audit or certify clients it advises. Certification decisions rest solely with an independent, GGL-accredited Certification Body.

Frequently Asked Questions

If we already hold FSC CoC or SBP certification, do we need to start from scratch? Not necessarily. The Certification Body evaluates the scope, claims and overlap between existing systems and GGL requirements to determine what can be reused and what requires GGL-specific development.

Is GGL recognised under the EU’s Renewable Energy Directive (RED)? As of now, GGL is officially recognised for the Japanese market (FIT/FIP) and the Dutch market (SDE++); the EU RED module is still pending recognition. Producers should confirm their specific buyer’s requirements before locking certification scope.

How is the GGL Participant fee calculated? It depends on the company’s role in the chain and the actual volume of GGL biomass sold or entered into the chain — not the plant’s nameplate capacity. Confirming this early prevents unexpected cost escalation.

Contact Us for Business Consulting

ISC Global supports producers from initial gap assessment through to certification completion, helping optimise time, cost and risk throughout the process.

Contact for business consulting:

Hotline: +84 933 096 426 – +84 868 591 260

Email: info@iscglobal.asia | van.pham@iscglobal.asia

Website: iscglobal.asia | iscglobal.edu.vn

Any factory that wants to manufacture goods bearing the Disney, Marvel, Star Wars, Pixar, or National Geographic brands must go through the Disney International Labor Standards (ILS) Program and obtain a Facility and Merchandise Authorization (FAMA). This guide explains, in practical terms, what the ILS Program requires, how the FAMA process works, which assessment pathway applies to Vietnam, and how manufacturers can prepare efficiently while avoiding the most common — and costly — mistakes.

1. What Is Disney ILS and Why Does It Matter?

Disney’s International Labor Standards (ILS) Program is the labor and workplace-conditions framework that The Walt Disney Company applies across its entire global supply chain — currently spanning roughly 40,000 facilities in nearly 100 countries. The Program requires Licensees and Vendors to ensure that facilities producing Disney-branded goods conduct regular ILS Audits and provide ILS Audit Reports, as set out in the ILS Program Manual (current edition: January 2024, subject to periodic revision). Disney manages Program requirements, statuses, and communications through its “Compass” system, accessible to authorized Licensees, Vendors, and their designated ILS Representatives.

The principles behind the Disney Code of Conduct for Manufacturers — the foundation of the ILS Program — are aligned with the core conventions of the International Labour Organization (ILO), covering child labor, forced labor, harassment and abuse, discrimination, freedom of association, workplace health and safety, and transparency.

2. FAMA: What It Is and What It Is Not

Facility and Merchandise Authorization (FAMA) is the authorization Disney issues to a specific Disney Licensee or Vendor to use a specific facility to produce a defined scope of Disney-branded merchandise.

It is important to understand what FAMA is not:

• It is not a general facility management-system certificate (unlike ISO 9001 or BSCI).
• It does not automatically transfer if the facility begins working with a different Licensee or Vendor.
• It is not issued automatically just because a facility passes an audit — Disney retains full discretion to accept, reject, or request clarification on any assessment report, and to inspect the facility at any time.

Crucially, the facility itself does not submit the FAMA Application. The Licensee or Vendor holding the contractual relationship with Disney is responsible for completing and submitting the FAMA Application through their designated Disney ILS Representative. This means the very first step for any manufacturer is to identify the correct Licensee/Vendor, deal or contract number, and ILS Representative — without this information, no assessment pathway can proceed to a valid FAMA outcome.

3. The Minimum Compliance Standard (MCS)

MCS is the compliance floor a facility must meet to be considered for Disney-branded production. It covers several critical areas:

Meeting MCS does not mean a facility has zero findings — non-conformities outside the MCS threshold still require continual improvement — but MCS violations are the “red lines” that can result in outright rejection of a FAMA application.

4. Requirements: Two Valid Assessment Pathways

Under Disney’s Country-Specific Submission Requirements Supplement, Vietnam is classified as a Permitted – Audit Required sourcing country. Within this classification, two assessment pathways apply, and choosing the correct one is essential:

Pathway A — Better Work Vietnam. Better Work — a joint program of the ILO and the International Finance Corporation (IFC) — operates in Vietnam, and factory participation in the garment/footwear sector is optional. However, if a facility does participate in Better Work, Disney will generally only accept the facility’s Better Work assessment, shared via the Better Work STAR portal (Third Party Access), rather than a separate ILS audit. For enrolled facilities, this is almost always the faster, lower-cost, and correctly recognized pathway.

Pathway B — Standalone Qualified ILS Audit. For facilities not enrolled in Better Work, a qualified ILS Audit must be conducted by an assessment body accepted under the ILS Program (e.g., SGS, Intertek, Control Union, Ecocert, QCCertification), following the audit protocol described in the ILS Program Manual.

A critical risk to avoid: booking a standalone social audit for a facility that is already a Better Work participant can result in Disney declining to accept the report — because it does not follow the required pathway for that facility’s status. Confirming pathway eligibility with the Disney ILS Representative before booking any audit is not optional; it is the single most effective way to avoid wasted cost and schedule delay.

5. How a Disney ILS Audit Is Conducted

For facilities following Pathway B, the independent assessment body typically follows this sequence:

1. Opening meeting, scope confirmation, and facility/organization mapping
2. Physical inspection of production areas, warehousing, utilities, clinic, canteen, emergency exits, chemical storage, and worker housing (if applicable)
3. Document review: permits, policies, labor records, timekeeping, wages, overtime, and benefits within a sample period
4. Confidential worker and management interviews, conducted without direct supervisors present
5. Cross-verification of consistency between records, interviews, and on-site observations
6. Closing meeting, findings confirmation, and issuance of the full audit report and Corrective Action Plan (CAP), if applicable

Audit duration (auditor-days) depends on workforce size, shift structure, number of buildings, and overall complexity — typically in the range of 12–16 auditor-days for a mid-to-large apparel or manufacturing facility.

6. The FAMA Submission Process, Step by Step

1. Precondition check — confirm Licensee/Vendor, deal information, and Disney ILS Representative.
2. Pathway determination — establish whether Better Work sharing or a standalone qualified ILS Audit applies.
3. Assessment execution — conducted by Better Work or a Disney-accepted independent assessment body.
4. CAP remediation (if findings arise) — closed within the program’s specified timeline.
5. FAMA Application submission — completed and submitted by the Licensee/Vendor, supported by the assessment report.
6. Disney review and decision — Disney may accept, request clarification, require re-assessment, or reject; processing can take approximately 30 days or longer depending on volume.

7. Why Training/Consultancy and Assessment Must Remain Separate

A well-run compliance program keeps two functions structurally separate: the party that helps the facility prepare (training, gap review, documentation readiness) and the party that conducts the independent assessment. This separation is not a bureaucratic formality — it is what preserves the objective, evidentiary value of the assessment report under Disney’s program principles. A consultancy that also performs the audit creates a conflict of interest that can undermine the credibility of the entire submission. Facilities should look for advisory partners who are explicit about this boundary, rather than firms that quietly offer to “guarantee a pass.”

8. Common Mistakes That Delay or Derail FAMA Applications

• Wrong pathway selection — booking a standalone audit for a Better Work-enrolled facility (or vice versa).
• Missing deal information — no confirmed Licensee/Vendor or contract number to anchor the submission.
• Incomplete scope declaration — undeclared buildings, shifts, dormitories, or subcontractors, which itself can constitute an MCS transparency violation.
• Unresolved CAP items — corrective actions not closed within the program’s required timeframe.
• Assuming FAMA portability — believing an existing FAMA with one Licensee automatically extends to a different Licensee or Vendor relationship. It does not; each Licensee/Vendor–facility relationship requires its own authorization.

9. Frequently Asked Questions

Does an existing ISO 9001 or BSCI certification satisfy Disney ILS requirements? No. Disney ILS is a distinct, independently managed program. Facilities must still undergo assessment under the ILS Program Manual or the Better Work pathway, regardless of other management-system certifications held.

How long does authorization remain valid? Maintaining a FAMA typically requires a new assessment annually, or on another schedule set by Disney — it is not a one-time, permanent authorization.

Can a consultancy guarantee a facility will pass? No credible advisor can guarantee outcomes, since the assessment is conducted independently and the final decision rests with Disney. A well-structured preparation program can, however, materially reduce the risk of critical findings and shorten processing time.

Contact for Business Advisory

ISC GLOBAL CO., LTD.

Hotline: +84 933 096 426 – +84 868 591 260

Email: info@iscglobal.asia | van.pham@iscglobal.asia

Website: iscglobal.asia | iscglobal.edu.vn