Product rules by country of origin; the combination matrix

Who must be established in the EU: GPSR economic operator (Reg. 2023/988, Art. 16), plus an authorised representative under Directive 2009/48/EC where the manufacturer appoints one.

• China — ⚠ GB 6675 is a Chinese standard. The EU asks for EN 71 test reports, CE and an EU operator.
• India — The BIS toy mark is Indian. The EU asks for EN 71 reports and a CE technical file.
• Vietnam — CR marking is Vietnamese. The EU asks for EN 71 reports and a CE technical file.
• Thailand — The TIS toy standard is Thai. The EU asks for EN 71 reports and a CE file.
• Türkiye — The customs union covers the border, not the product: Directive 2009/48/EC applies in full.
• USA — ASTM F963 and CPSIA give no presumption of conformity in the EU. EN 71 is what counts.
• Indonesia — SNI toy certification is Indonesian. The EU asks for EN 71 reports and CE.
• Bangladesh — Duty-free access under Everything But Arms does not touch the Toy Safety Directive.
• South Korea — The KC children's-product mark is Korean. The EU asks for EN 71 and CE.
• Japan — The ST mark is a voluntary Japanese scheme. The EU asks for EN 71 and CE.
• Brazil — INMETRO toy certification is Brazilian. The EU asks for EN 71 and CE.
• Pakistan — GSP+ lowers the duty, not the EN 71 testing or the CE technical file.
• Malaysia — No agreement and no shortcut: EN 71 reports, CE marking, an EU operator.
• Taiwan — BSMI and the CNS standards are Taiwanese. The EU asks for EN 71 and CE.

Who must be established in the EU: GPSR economic operator (Reg. 2023/988, Art. 16) and the operator required by Art. 4 of Reg. 2019/1020 for CE-marked goods.

• China — ⚠ CCC is Chinese. The EU needs a declaration under LVD, EMC, RED and RoHS, plus WEEE.
• India — BIS registration is Indian. The EU needs the CE stack, RoHS and WEEE registration.
• Vietnam — The EVFTA cuts duty only. LVD, EMC, RED, RoHS and WEEE are unchanged.
• Thailand — TIS marking is Thai. The EU needs the CE stack, RoHS and WEEE registration.
• Türkiye — The customs union covers duty. CE, RoHS, WEEE and the battery rules apply in full.
• USA — FCC and UL listings are not CE. The EU needs its own declaration under LVD, EMC and RED.
• Indonesia — SNI and SDPPI approvals are Indonesian. The EU needs the CE stack and WEEE.
• Bangladesh — Duty-free access does not touch CE marking, RoHS or WEEE registration.
• South Korea — The KC mark is Korean and the FTA cuts duty; the EU declaration is still required.
• Japan — PSE and TELEC are Japanese. The EU needs its own declaration under LVD, EMC and RED.
• Brazil — INMETRO and ANATEL are Brazilian. The EU declaration and WEEE are still required.
• Pakistan — GSP+ lowers the duty, not the CE stack, RoHS or the WEEE registration per country.
• Malaysia — SIRIM approval is Malaysian. The EU needs the CE stack, RoHS, WEEE and batteries.
• Taiwan — BSMI and NCC are Taiwanese. The EU declaration, RoHS and WEEE are still required.

Who must be established in the EU: Responsible Person under Reg. 1223/2009, Art. 4, named on the label. This is a different role from the GPSR one, with its own duties.

• China — NMPA filing is Chinese. The EU asks for CPNP notification, a PIF and an EU Responsible Person.
• India — CDSCO import registration is Indian. The EU asks for CPNP, a PIF and an EU Responsible Person.
• Vietnam — An ASEAN cosmetic notification is not a CPNP entry. CPNP, PIF and an EU Responsible Person.
• Thailand — An ASEAN cosmetic notification is not a CPNP entry. CPNP, PIF and an EU Responsible Person.
• Türkiye — The customs union does not cover cosmetics notification. CPNP is required before the first sale.
• USA — FDA facility registration is not a CPNP entry. An EU Responsible Person is required.
• Indonesia — BPOM notification is Indonesian. The EU asks for CPNP, a PIF and an EU Responsible Person.
• Bangladesh — Duty preference changes nothing under 1223/2009: CPNP, PIF, EU Responsible Person.
• South Korea — ⚠ K-beauty: MFDS status carries no EU weight. CPNP, PIF and an EU Responsible Person.
• Japan — The EPA cuts duty; 1223/2009 is unchanged. CPNP notification before the first sale.
• Brazil — ANVISA registration is Brazilian. The EU asks for CPNP, a PIF and an EU Responsible Person.
• Pakistan — GSP+ lowers the duty, not the CPNP notification, the PIF or the safety assessment.
• Malaysia — An ASEAN cosmetic notification is not a CPNP entry. CPNP, PIF and an EU Responsible Person.
• Taiwan — TFDA registration is Taiwanese. The EU asks for CPNP, a PIF and an EU Responsible Person.

Who must be established in the EU: No GPSR role: the GPSR does not apply to food (Reg. 2023/988, Art. 2(2)). What is needed is a food business operator in the EU and a national notification per member state.

• China — ⚠ Novel-food status per ingredient, and a CHED-D in TRACES where the commodity is listed in 2019/1793.
• India — ⚠ Botanicals: novel-food status, the on-hold claims position, and 2019/1793 controls on some commodities.
• Vietnam — Novel-food status per ingredient; national notification in each member state of sale.
• Thailand — Novel-food status per ingredient; national notification in each member state of sale.
• Türkiye — The customs union does not cover food law. National notification per member state.
• USA — US dietary-supplement status is not EU status. Check novel-food status per ingredient first.
• Indonesia — Botanical ingredients: settle novel-food status before the first order, not after.
• Bangladesh — Duty-free access does not touch food law, notification or the border controls.
• South Korea — Health-functional-food status is Korean. The EU asks for novel-food status and notification.
• Japan — FOSHU status is Japanese. The EU asks for novel-food status and national notification.
• Brazil — ANVISA registration is Brazilian. The EU asks for novel-food status and notification.
• Pakistan — GSP+ lowers the duty, not the novel-food check or the national notifications.
• Malaysia — Botanical ingredients: settle novel-food status before the first order, not after.
• Taiwan — TFDA status is Taiwanese. The EU asks for novel-food status and national notification.

Who must be established in the EU: EU authorised representative under MDR/IVDR Art. 11, jointly and severally liable with the manufacturer, plus a person responsible for regulatory compliance.

• China — NMPA registration is Chinese. The EU asks for the MDR class, an EU authorised representative, UDI and EUDAMED.
• India — A CDSCO device licence is Indian. The EU asks for the MDR class, an EU authorised representative and UDI.
• Vietnam — The FTA does not touch the MDR route: class, EU authorised representative, UDI, EUDAMED.
• Thailand — A Thai FDA licence is national. The EU asks for the MDR class, an EU authorised representative and UDI.
• Türkiye — The customs union does not cover the MDR. An EU authorised representative and EUDAMED are required.
• USA — ⚠ A 510(k) clearance or PMA carries no EU status. The MDR or IVDR route has to be run separately.
• Indonesia — Ministry of Health registration is Indonesian. The EU asks for the MDR class, an EU representative and UDI.
• Bangladesh — Duty-free access does not touch the MDR. An EU authorised representative and UDI are required.
• South Korea — MFDS approval is Korean. The EU asks for the MDR class, an EU authorised representative and UDI.
• Japan — PMDA approval is Japanese. The EU asks for the MDR class, an EU authorised representative and UDI.
• Brazil — ANVISA registration is Brazilian. The EU asks for the MDR class, an EU authorised representative and UDI.
• Pakistan — DRAP registration is Pakistani. The EU asks for the MDR class, an EU authorised representative and UDI.
• Malaysia — ⚠ MDA registration is Malaysian. The EU asks for the MDR class, an EU authorised representative, UDI and EUDAMED.
• Taiwan — A TFDA licence is Taiwanese. The EU asks for the MDR class, an EU authorised representative and UDI.

Who must be established in the EU: GPSR economic operator (Reg. 2023/988, Art. 16), and an EUDR operator for the due diligence statement where the product contains wood.

• China — ⚠ EUDR: the plot data has to come from where the timber was harvested, not from the furniture factory.
• India — Formaldehyde emission 0.062 mg/m³ on the article (REACH entry 77); EUDR where a part is wood.
• Vietnam — ⚠ EUDR: much timber is re-exported through Vietnam. Trace it to the plot, not to the mill.
• Thailand — ⚠ EUDR where wood is used; formaldehyde emission 0.062 mg/m³ measured on the article.
• Türkiye — The customs union does not cover the EUDR or REACH entry 77. Both apply in full.
• USA — ⚠ The EUDR applies to US hardwood as well: plot geolocation, legality, deforestation-free.
• Indonesia — ⚠ EUDR: a FLEGT licence evidences legality, not that the plot was deforestation-free.
• Bangladesh — Formaldehyde emission 0.062 mg/m³ on the article; the EUDR applies if wood is used.
• South Korea — Formaldehyde emission 0.062 mg/m³ on the article; EUDR where a wood part is used.
• Japan — Formaldehyde emission 0.062 mg/m³ on the article; EUDR where a wood part is used.
• Brazil — ⚠ EUDR bites hardest here: plot geolocation and deforestation-free evidence for the timber.
• Pakistan — GSP+ lowers the duty, not the EUDR due diligence statement or REACH entry 77.
• Malaysia — ⚠ EUDR for the timber: plot geolocation and deforestation-free evidence before customs.
• Taiwan — Formaldehyde emission 0.062 mg/m³ on the article; EUDR where a wood part is used.

Who must be established in the EU: GPSR economic operator (Reg. 2023/988, Art. 16), plus a registered producer per member state for textile EPR.

• China — ⚠ REACH entries 43, 72 and 79 on the fabric; fibre label in the language of each market.
• India — ⚠ REACH entries 43 and 72 per fabric; textile EPR registration per member state, not only France.
• Vietnam — The EVFTA cuts duty; REACH testing, fibre labelling and textile EPR are unchanged.
• Thailand — REACH entries 43 and 72 per fabric; fibre label in the language of each market.
• Türkiye — The customs union covers the border; fibre labelling, REACH and textile EPR apply.
• USA — 16 CFR 1610 is a US flammability rule. The EU asks for fibre labelling and REACH testing.
• Indonesia — REACH entries 43 and 72 per fabric; textile EPR registration per member state.
• Bangladesh — ⚠ Duty-free access does not touch REACH entries 43 and 72, or the EPR registrations.
• South Korea — The FTA cuts duty; fibre labelling, REACH and textile EPR are unchanged.
• Japan — The EPA cuts duty; fibre labelling, REACH and textile EPR are unchanged.
• Brazil — The Mercosur preference cuts duty; REACH testing and textile EPR are unchanged.
• Pakistan — ⚠ GSP+ lowers the duty, not REACH entries 43, 72 and 79, or the EPR registrations.
• Malaysia — REACH entries 43 and 72 per fabric; textile EPR registration per member state.
• Taiwan — REACH entries 43 and 72 per fabric; textile EPR registration per member state.