2026-09-21 · Equipo editorial KeXinMaterials
REACH / RoHS / California Prop 65: Guía de Cumplimiento B2B para Cajas de Protección 2026
Tres marcos de cumplimiento químico rigen la adquisición B2B de cajas de protección en UE + EE.UU.: REACH (reglamento químico UE), RoHS (sustancias peligrosas UE), California Prop 65 (advertencia cancerígeno EE.UU.). El cumplimiento afecta la selección de materiales, pruebas, documentación.
Descripción general REACH (UE)
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the EU chemical regulation 1907/2006. Affects all products manufactured in / imported to EU.
Scope: all chemical substances used in products manufactured in / imported to EU. 100,000+ substances registered. SVHC (Substances of Very High Concern) list: 247 substances as of 2024 (updated twice yearly by ECHA).
SVHC threshold: 0.1% w/w (weight/weight) per article triggers disclosure obligation. For protective cases, SVHC content typically <0.1% for all components (PP, ABS, PU foam, brass, aluminum, stainless steel).
Communication obligation: if SVHC >0.1%, supplier must communicate to downstream recipients within 45 days of request. B2B buyers can request SVHC disclosure at any time.
Authorization: certain SVHCs (Annex XIV) require authorization for use. Current Annex XIV has ~50 substances. None commonly used in protective cases.
B2B buyer action: request SVHC disclosure from supplier. Include in supplier quality agreement. Update annually as SVHC list evolves.
Descripción general RoHS (UE)
RoHS (Restriction of Hazardous Substances) Directive 2011/65/EU + (EU) 2015/863 restricts 10 substances in electrical/electronic equipment. Protective cases are exempt unless they contain electronic components.
RoHS 10 restricted substances: lead (Pb), mercury (Hg), cadmium (Cd), hexavalent chromium (Cr6+), PBB, PBDE, DEHP, BBP, DIBP (4 phthalates added 2015/863). Threshold 0.1% w/w for most, 0.01% for Cd.
Scope: electrical and electronic equipment. Pure mechanical cases without electronics are exempt. Cases with built-in electronics (locks, sensors, lighting) must comply.
For pure mechanical protective cases: RoHS typically not required but voluntary compliance is industry standard.
For cases with electronics: RoHS mandatory. Test report from third-party lab (SGS, TUV, Intertek) required.
B2B buyer action: request RoHS test report per case model. Required for cases with electronics. Optional for pure mechanical.
Descripción general California Prop 65
California Proposition 65 (Safe Drinking Water and Toxic Enforcement Act 1986) requires warning labels for products exposing California consumers to 800+ carcinogen / reproductive toxic chemicals.
Scope: products sold in California exposing consumers to listed chemicals above safe harbor levels. 800+ chemicals listed by OEHHA. Updated annually.
Common Prop 65 chemicals in protective cases: lead, cadmium, DEHP, BBP (phthalates). May be present in plastic colorants, stabilizers, plasticizers.
Warning requirement: if any listed chemical >safe harbor level, product must carry "WARNING: Cancer and Reproductive Harm - www.P65Warnings.ca.gov" label.
OR compliance option: ensure all listed chemicals below safe harbor levels (typically <0.05% for carcinogens, <0.1% for reproductive toxicants). Test report required.
Enforcement: California Attorney General + private citizens can sue. Penalties up to USD 2,500/day/violation. B2B sellers to California should ensure Prop 65 compliance.
Otras regulaciones químicas (global)
Beyond REACH / RoHS / Prop 65, several other chemical regulations affect B2B protective case procurement globally.
TSCA (US Toxic Substances Control Act): US chemical inventory. Pre-market notice required for new chemicals. Affects US imports.
K-REACH (Korea REACH): Korean equivalent of EU REACH. Mandatory pre-market registration for new substances. Affects Korea imports.
China REACH (中国化学品登记): GB 30000 series standards. Mandatory for chemicals manufactured / imported in China.
Japan CSCL (Chemical Substances Control Law): Japan chemical inventory. Pre-market registration. Affects Japan imports.
BSCI / Sedex / RBA (social compliance): worker safety + environmental compliance audits. Affects global B2B brand buyers (Wal-Mart, Amazon, IKEA).
Documentación + pruebas B2B
B2B buyers should require documentation and testing for chemical compliance. Standard documentation packages below.
Material declaration: full material composition of all components. From material suppliers (PP, ABS, PU foam, brass, aluminum, stainless steel). Updated annually.
SVHC test report: third-party test report confirming SVHC <0.1% w/w per article. Per EU REACH. Required for EU market.
RoHS test report: third-party test report confirming RoHS 10 substances below thresholds. Per EU RoHS 2015/863. Required for cases with electronics.
Prop 65 test report: third-party test report confirming Prop 65 chemicals below safe harbor levels. Or Prop 65 warning label compliance. Required for California market.
SDS (Safety Data Sheet): required for any chemical substance or mixture. Provided by material supplier.
Auditoría de fábrica + cadena de suministro
Compliance is only as good as the supply chain. Factory audit + supplier qualification are critical.
Factory audit: ISO 9001:2015 (quality management) + ISO 14001:2015 (environmental management) baseline. Social compliance audits (BSCI / Sedex) for EU/US brand buyers.
Material supplier qualification: PP, ABS, PU foam suppliers should provide material certificates. Annual audit preferred.
Incoming material inspection: random sampling and testing for SVHC / RoHS / Prop 65. Quarterly or per batch.
Sub-tier supplier disclosure: brass, aluminum, stainless steel, foam may contain SVHC from sub-suppliers. Downstream disclosure required.
Recycling + circular economy: EU CSRD + US SEC climate disclosure require Scope 3 supply chain reporting. Recyclable / mono-material cases preferred.
Impacto costo + plazo
Chemical compliance adds cost and lead time. Standard cost ranges below.
Material declaration: USD 200-500 per case model. Provided by material suppliers. Lead time 1-2 weeks.
SVHC test report: USD 500-1500 per case model. Third-party lab (SGS / TUV / Bureau Veritas). Lead time 2-4 weeks.
RoHS test report: USD 500-1500 per case model. Lead time 2-4 weeks.
Prop 65 test report: USD 800-2500 per case model. Lead time 3-6 weeks. Higher cost due to larger chemical list (800+).
Combined REACH + RoHS + Prop 65 test program: USD 1500-4500 per case model. Lead time 4-8 weeks.
Capacidad de cumplimiento de KeXinMaterials
KeXinMaterials provides full REACH / RoHS / Prop 65 compliance documentation for protective cases. EXW Shenzhen / FOB Shenzhen / FOB Ningbo only.
Certifications: REACH SVHC declaration + RoHS 2015/863 + California Prop 65. Updated annually or upon SVHC list change.
Test partners: SGS, TUV Rheinland, Bureau Veritas. Test reports accepted globally including EU, US, Japan, Korea, Canada.
Material sourcing: virgin PP, ABS, PU foam, brass, aluminum, stainless steel from ISO 14001:2015 certified suppliers.
Custom compliance: per-customer REACH / RoHS / Prop 65 documentation packages available. Includes material declaration + test reports + audit reports.
Social compliance: BSCI / Sedex audit ready. Available on request for global brand buyers.
Puntos clave
- REACH SVHC <0.1% w/w por artículo; comunicar a downstream dentro de 45 días
- RoHS 10 sustancias; obligatorio para cajas con electrónica, voluntario para mecánica pura
- Prop 65: <niveles safe harbor o etiqueta de advertencia; sanciones USD 2,500/día/violación
- Documentación: declaración de materiales + informes de prueba + SDS + auditoría de fábrica
- Costo: USD 500-4500 por modelo de caja; plazo 2-8 semanas
Preguntas frecuentes
¿REACH es lo mismo que RoHS?
No. REACH es un reglamento químico UE integral que cubre todas las sustancias en productos. RoHS es una directiva más estrecha que restringe 10 sustancias peligrosas específicas en equipos eléctricos/electrónicos.
¿Las cajas de protección puramente mecánicas necesitan RoHS?
No. RoHS es obligatorio solo para equipos eléctricos/electrónicos.
¿Cuál es el umbral SVHC en REACH?
El umbral SVHC es 0.1% w/w por artículo.
¿Cuál es la sanción por incumplimiento de Prop 65?
Sanciones Prop 65: hasta USD 2,500/día/violación.
¿Con qué frecuencia se actualiza la lista SVHC?
La lista candidata SVHC (REACH) se actualiza semestralmente por ECHA.
¿Puede una fábrica china proporcionar documentación de cumplimiento Prop 65?
Sí. Las fábricas chinas (incluida KeXinMaterials) proporcionan documentación de cumplimiento Prop 65 a través de laboratorios externos.
¿Cuál es la diferencia entre RoHS 2 y RoHS 3?
RoHS 2: 6 sustancias restringidas originales. RoHS 3: agregó 4 ftalatos a la lista restringida.