2026-09-21 · KeXinMaterials 編集チーム

REACH SVHC + RoHS 3.0 + PFAS-Stoffbeschränkung Schutzkoffer B2B-Leitfaden

EU REACH-Verordnung (EG) 1907/2006 + RoHS-3-Richtlinie 2011/65/EU + 2024 PFAS-Beschränkungsvorschlag beschränken Stoffe in Produkten auf dem EU-Markt. Schutzkoffer mit Polymeren + Metallen + Elektronik erfordern SVHC-Erklärung (REACH), RoHS-Compliance (Elektronik), PFAS-Erklärung (falls zutreffend).

REACH Regulation (EC) 1907/2006 Scope

REACH (Registration, Evaluation, Authorisation, Restriction of Chemicals) regulates chemical substances in EU market. Includes SVHC declaration obligation for articles.

Regulation (EC) 1907/2006: REACH entered June 2007. Phased implementation 2009-2018. Currently in force.

REACH scope: All chemical substances manufactured or imported into EU in quantities > 1 tonne/year. Includes substances in articles (products).

SVHC (Substances of Very High Concern): Substances that may have serious effects on human health or environment. Listed on ECHA Candidate List.

Candidate List: Maintained by ECHA (European Chemicals Agency). Updated twice yearly (January + July). Currently 247 substances (2025).

SVHC threshold: Articles containing SVHC > 0.1% w/w (weight by weight) require communication to recipients + notification to ECHA SCIP database.

Communication obligation: Article supplier must provide SVHC information to B2B recipient if SVHC > 0.1% w/w. Free of charge within 45 days.

Notification obligation: Article producer / importer must notify ECHA SCIP database if SVHC > 0.1% w/w AND article > 1 tonne/year.

Authorisation: Substances on Annex XIV require authorisation for continued use. Sunset date = deadline for use.

Restriction: Substances on Annex XVII restricted in specific applications. e.g., phthalates restricted in toys.

B2B relevance: For EU-bound protective cases, must verify SVHC content + SCIP notification + supplier REACH compliance declaration.

RoHS 3 Directive 2011/65/EU

RoHS 3 restricts 10 substances in electrical and electronic equipment (EEE). Current Directive 2011/65/EU + delegated amendments.

Directive 2011/65/EU: RoHS 2 recast. Entered force January 2013. RoHS 3 = 2011/65/EU + (EU) 2015/863 adding 4 phthalates.

Scope: Electrical and electronic equipment (EEE) placed on EU market. Includes components, sub-assemblies, finished products.

10 restricted substances: Lead (Pb), mercury (Hg), cadmium (Cd), hexavalent chromium (Cr VI), PBB, PBDE, DEHP, BBP, DBP, DIBP.

Maximum concentration values (MCV): 0.1% w/w for most substances. 0.01% w/w (100 ppm) for cadmium. By homogeneous material.

Lead (Pb): Common in steel, aluminum, copper alloys. Restricted to 0.1% w/w. Exemption for copper alloy < 4% lead (w/w).

Cadmium (Cd): Restricted to 0.01% w/w (100 ppm). Very strict. Common in Ni-Cd batteries, pigments, plating.

Mercury (Hg): Restricted to 0.1% w/w. Common in fluorescent lamps, switches, relays.

Hexavalent chromium (Cr VI): Restricted to 0.1% w/w. Common in plating, anti-corrosion coatings, pigments.

PBB / PBDE: Restricted to 0.1% w/w. Brominated flame retardants in plastics.

DEHP / BBP / DBP / DIBP (4 phthalates): 0.1% w/w each. Added by RoHS 3 / (EU) 2015/863. Plasticizers in polymers.

Homogeneous material: Single substance or uniform mixture. e.g., a single plastic = one homogeneous material. Solder joint = one material. Surface coating = one material.

Exemptions: Annex III lists specific exemptions (e.g., lead in solder for servers, lead in steel for machining). Time-limited. Check current exemptions.

RoHS 3 amendment 2025: Proposal to add 4 PFAS substances to RoHS restricted list. Pending EU Parliament approval.

B2B relevance: For EU-bound protective cases containing electronic components, require RoHS 3 compliance declaration from component supplier.

PFAS Restriction Proposal 2024 + EU REACH Annex XVII

EU PFAS restriction proposal (Feb 2024) aims to ban ~10,000 PFAS substances over broad industries. Significant impact on protective case coatings, gaskets, electronics.

PFAS (Per- and polyfluoroalkyl substances): ~10,000+ substances. Used in coatings, gaskets, water-resistant fabrics, electronics, fire-fighting foam.

PFAS restriction proposal: Published Feb 2024 by ECHA on behalf of 5 EU member states (Germany, Netherlands, Denmark, Sweden, Norway).

PFAS scope: All PFAS substances. Exemptions for some uses (pharma, semiconductors, defense, certain industrial processes).

PFAS in protective cases: Coatings (water repellent), gaskets (PTFE), cable insulation (PTFE), electronics (PCB laminate).

Timeline: Proposal published Feb 2024 → ECHA committees review → RAC + SEAC opinions → EU Commission adoption → 18-42 month transition after adoption.

Estimated ban date: 2026-2027 EU Commission adoption. Full transition 2028-2030.

PTFE (polytetrafluoroethylene): Most common PFAS in protective cases (gasket + coating). Will be restricted if proposal adopted.

Alternative materials: Silicone rubber, EPDM, nitrile rubber, TPE. Must verify performance vs PTFE for temperature / chemical / water resistance.

B2B impact: PFAS restriction adds 5-15% cost if alternative materials required. Long-term direction is PFAS-free.

Other jurisdictions: US state laws (CA, NY, ME, MN) + Canada + UK. Some PFAS bans already in effect.

B2B recommendation: For 2026+ EU-bound orders, request PFAS declaration from supplier. Plan transition to PFAS-free alternatives (silicone + EPDM).

SCIP Database + Declaration of Conformity

SCIP database (ECHA) collects SVHC notifications for articles placed on EU market. Declaration of Conformity documents compliance with REACH + RoHS + PFAS.

SCIP database: Substances of Concern In Products. ECHA database. Mandatory notifications since January 2021.

SCIP notification: Article producer / importer must submit SVHC information to SCIP if article > 1 tonne/year AND SVHC > 0.1% w/w.

SCIP number: Unique identifier per article. Format: SCIP-1234-5678-9012-3456. Required for SCIP database lookup.

SCIP contents: Article identifier, component articles, SVHS identified, material category, safe use instructions.

Public access: SCIP database publicly searchable at https://echa.europa.eu/scip-database. B2B buyers can verify supplier compliance.

Declaration of Conformity (DoC): Document where supplier declares product compliance with specific regulations. Required for REACH + RoHS + CE marking.

DoC structure: (1) Product identification. (2) Regulation + directive list. (3) Harmonised standards applied. (4) Notified Body (where applicable). (5) Manufacturer signature + date.

DoC for REACH: Declaration that product does not contain SVHC > 0.1% w/w (or SCIP submitted). Required for EU market.

DoC for RoHS: Declaration that product complies with RoHS 2 + 3 restricted substances and MCV. Required for EEE placed on EU market.

DoC for PFAS: Currently voluntary but recommended. Will become mandatory if PFAS restriction adopted (2027+).

Retention: DoC must be retained by manufacturer for 10 years after product placed on market. Available to authorities on request.

B2B procurement: Request DoC + SCIP lookup for each SVHC + RoHS test report per homogeneous material. Maintain 10-year records.

REACH + RoHS + PFAS B2B Procurement Workflow

5-step B2B procurement workflow for REACH + RoHS + PFAS compliance on protective cases + electronic components.

Step 1: Identify regulatory scope. EU-bound = REACH + RoHS 3 + (PFAS if proposal adopted). US-bound = TSCA + state PFAS laws. China = China RoHS + GB/T substances.

Step 2: Request supplier documentation. REACH SVHC declaration + RoHS 3 DoC + SCIP number + PFAS declaration (if applicable).

Step 3: Verify SCIP database entry. Search by article name or supplier. Verify SVHC content matches declaration.

Step 4: Test if uncertain. XRF analysis for metals (Cd, Pb, Hg, Cr VI). GC-MS for polymers (phthalates, PBB/PBDE). Cost EUR 200-2000 per test.

Step 5: Maintain records. DoC + SCIP + test reports retained 10 years per EU REACH. Available on request to authorities + B2B buyers.

Common B2B mistakes: (1) Accepting ISO 9001 QMS without REACH DoC. (2) Missing SCIP notification for SVHC. (3) RoHS test only on finished case (not on homogeneous material). (4) PFAS in coatings not declared.

Supplier qualification: REACH SVHC declaration + RoHS 3 DoC + SCIP notification + PFAS declaration (2026+) + ISO 14001 environmental mgmt preferred.

Test report: Per homogeneous material, not per product. e.g., plastic shell = 1 test. Solder joints = 1 test per type. Surface coating = 1 test.

B2B cost impact: REACH + RoHS compliance adds 1-5% to protective case cost. PFAS-free alternatives may add 5-15% if needed.

B2B recommendation: For EU-bound protective cases, require REACH SVHC declaration + RoHS 3 DoC + SCIP notification + PFAS declaration (2026+). Maintain 10-year records.

よくある質問

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