V5 Ultimate
Ultimate
PricingResourcesCompany
English (original)DeutschΕλληνικάEspañolFrançaisItalianoעברית日本語한국어NederlandsPolskiPortuguêsSvenska
Talk to us Log in Start free trial
Food & Beverage
  • Bakery & Confectionery
  • Food Processing
  • Ingredients & Dry Mixes
  • Sausage & Meat Products
  • Produce Packing
  • Pet Food & Pet Supplements
  • Dairy & Chilled Foods
  • Beverages & Liquid Manufacturing
  • Infant Formula
Pharma & Life Sciences
  • Radiopharmaceuticals
  • Pharmaceutical
  • Medical Devices
  • Veterinary Pharmaceuticals
  • Blood & Tissue
  • Diagnostics & IVD Kits
  • Reference Materials & Standards
  • OTC Topical Creams & Gels
Supplements & Personal Care
  • Dietary Supplements
  • Cosmetics & Personal Care
  • Cannabis & Hemp Manufacturing
  • Fragrances & Perfumery
  • Soaps & Personal Hygiene
  • Botanical Extracts & Essential Oils
Chemicals & Materials
  • Plastics & Resins
  • Agricultural Chemicals
  • Specialty & Industrial Chemicals
  • Printing Inks, Pigments & Construction Chemicals
  • Lubricants & Metalworking Fluids
  • Coatings, Adhesives & Sealants
Other Manufacturing
  • Consumer Products
  • Electronics & Electrical Assembly
  • Textiles & Nonwoven
  • Contract Manufacturing & Co-Packing
  • Packaging & Food-Contact Materials
  • Regulated Warehousing & Distribution
Explore all industries
  • Warehouse & TraceabilityReceive, store, pick and trace
  • Production & PlanningPlan jobs and guide production
  • Quality & LaboratoryTest, investigate and review
  • Documents & TrainingControl procedures and qualifications
  • Equipment & PerformanceMaintain assets and measure losses
  • Orders & IntegrationsConnect customers, suppliers and systems
  • Outputs & InsightsReports, KPIs and label design
Why V5? Product & Features
Why V5?Product & Features
  • Warehouse & TraceabilityReceive, store, pick and trace
  • Production & PlanningPlan jobs and guide production
  • Quality & LaboratoryTest, investigate and review
  • Documents & TrainingControl procedures and qualifications
  • Equipment & PerformanceMaintain assets and measure losses
  • Orders & IntegrationsConnect customers, suppliers and systems
  • Outputs & InsightsReports, KPIs and label design
Explore all industries
    • Bakery & Confectionery
    • Food Processing
    • Ingredients & Dry Mixes
    • Sausage & Meat Products
    • Produce Packing
    • Pet Food & Pet Supplements
    • Dairy & Chilled Foods
    • Beverages & Liquid Manufacturing
    • Infant Formula
    • Radiopharmaceuticals
    • Pharmaceutical
    • Medical Devices
    • Veterinary Pharmaceuticals
    • Blood & Tissue
    • Diagnostics & IVD Kits
    • Reference Materials & Standards
    • OTC Topical Creams & Gels
    • Dietary Supplements
    • Cosmetics & Personal Care
    • Cannabis & Hemp Manufacturing
    • Fragrances & Perfumery
    • Soaps & Personal Hygiene
    • Botanical Extracts & Essential Oils
    • Plastics & Resins
    • Agricultural Chemicals
    • Specialty & Industrial Chemicals
    • Printing Inks, Pigments & Construction Chemicals
    • Lubricants & Metalworking Fluids
    • Coatings, Adhesives & Sealants
    • Consumer Products
    • Electronics & Electrical Assembly
    • Textiles & Nonwoven
    • Contract Manufacturing & Co-Packing
    • Packaging & Food-Contact Materials
    • Regulated Warehousing & Distribution
PricingResourcesCompany
Start free trial Log in Talk to us
Readiness guide · REACH and RoHS

REACH Article 33 and RoHS: know what is in each part before you sell it in the EU

Link every supplier declaration to the part revision it covers, and record which substance list version it was checked against.

5 min readFor product compliance, sourcing and quality leads at consumer and electrical product makers, importers and private-label brands
Operator in hood, coverall, mask, safety glasses and blue gloves logging a container of recycled plastic regrind on a tablet

In Short

  1. 1SVHC above 0.1% w/w: tell customers.
  2. 2Consumers: answer within 45 days.
  3. 3RoHS: per homogeneous material.
Contents
  1. Two different questions
  2. REACH Article 33: telling customers and consumers
  3. REACH Article 7(2): notifying the Agency
  4. RoHS: Annex II limits and manufacturer duties
  5. Supplier data you can rely on
  6. Questions
Contents
  1. Two different questions
  2. REACH Article 33: telling customers and consumers
  3. REACH Article 7(2): notifying the Agency
  4. RoHS: Annex II limits and manufacturer duties
  5. Supplier data you can rely on
  6. Questions

Makers and importers of consumer and electrical products need two kinds of substance evidence in the EU. This guide covers the REACH information duties for substances of very high concern in articles (Regulation (EC) No 1907/2006, Articles 7(2) and 33, as published in 2006) and the RoHS Directive (2011/65/EU, Articles 4 and 7 and Annex II, as published in 2011). Not opened: later amendments, including additions to RoHS Annex II, REACH Annex XVII, the SCIP database rules, the current Candidate List, court rulings and UK REACH. It is orientation, not legal advice. Sources checked 5 Oct 2026.

01

Two different questions

REACH and RoHS ask different things. REACH Article 33 is about information: if an article contains a substance of very high concern above a threshold, you must pass information down the chain.

More on two different questions

RoHS is about restriction: electrical and electronic equipment must not contain listed substances above set limits. A product can be RoHS compliant and still trigger REACH duties, or the reverse. Your evidence therefore needs to show both what each part contains and which rule you checked it against.

02

REACH Article 33: telling customers and consumers

Article 33(1) says any supplier of an article containing a substance meeting the Article 57 criteria and identified under Article 59(1), the Candidate List, above 0.1% weight by weight must give the recipient enough information, available to the supplier, to allow safe use, including at least the substance name. Under Article 33(2), the same information goes to a consumer on request, free of charge, within 45 days of receiving the request.

Article 33(2) consumer request

0 of 6 in place
Summary of REACH Article 33(2).
More on rEACH Article 33: telling customers and consumers

Track request dates so the 45-day clock is visible.

03

REACH Article 7(2): notifying the Agency

Article 7(2) requires a producer or importer of articles to notify the European Chemicals Agency where a Candidate List substance is present in those articles above 0.1% weight by weight and in quantities totalling over 1 tonne per producer or importer per year. Article 7(1) separately covers registration of substances intended to be released from articles.

More on rEACH Article 7(2): notifying the Agency

Because the Candidate List grows over time, schedule a periodic recheck of your parts against the current list, with the result and reviewer recorded.

04

RoHS: Annex II limits and manufacturer duties

RoHS Article 4(1) says equipment placed on the market, including cables and spare parts, must not contain the substances in Annex II. Article 4(2) applies the maximum concentration by weight in homogeneous materials.

Worked Example: Desk Lamp DL-60, Part Evidence

Part (rev)REACH SVHCRoHS
Cable assembly CB-2 (B)Declaration, list checked Jul 2026Test report per material
Housing HS-9 (D)Declaration due for reviewSupplier declaration
PCB assembly PB-4 (A)Declaration on fileDeclaration plus spot test
  • Cable assembly CB-2 (B)
    REACH SVHC
    Declaration, list checked Jul 2026
    RoHS
    Test report per material
  • Housing HS-9 (D)
    REACH SVHC
    Declaration due for review
    RoHS
    Supplier declaration
  • PCB assembly PB-4 (A)
    REACH SVHC
    Declaration on file
    RoHS
    Declaration plus spot test
Invented example. Compliance team decides adequacy.
More on roHS: Annex II limits and manufacturer duties

The 2011 Annex II lists lead, mercury, hexavalent chromium, PBB and PBDE at 0.1% and cadmium at 0.01%; later amendments were not opened. Article 7 requires manufacturers to draw up technical documentation, carry out internal production control, issue an EU declaration of conformity, affix CE marking and keep documentation for 10 years.

05

Supplier data you can rely on

Most substance evidence comes from suppliers: declarations, test reports and material data. Link each declaration to the part number and revision it covers, record its date and the substance list version it was checked against, and set a review date.

More on supplier data you can rely on

When a supplier, material or revision changes, the declaration should be reviewed before the new part is used. People in compliance and quality decide whether evidence is adequate; a declaration on file is not the same as a decision.

How V5 supports this

V5 keeps supplier declarations, part revisions and documents linked with review dates. Your compliance team decides whether a product complies.

  • Supplier PortalSuppliers upload declarations and certificates.
  • Approved SuppliersSupplier approval status and documents.
  • Document controlApproved, versioned documents with review history.

Questions

Does REACH Article 33 require a label on the product?

Article 33 requires information sufficient for safe use, at least the substance name, to recipients, and to consumers on request within 45 days. The articles read do not prescribe a label.

How is the RoHS limit measured?

Article 4(2) applies the maximum concentration values by weight in homogeneous materials. Read the definitions in Article 3 before calculating, and check later amendments to Annex II.

Does RoHS apply to medical devices?

Article 4(3) applied the restriction to medical devices placed on the market from 22 July 2014 and to in vitro diagnostic devices from 22 July 2016, subject to exemptions.

Does V5 decide whether a product complies?

No. V5 keeps supplier declarations, part revisions and documents linked with review dates. Your compliance team decides whether a product meets each rule.

Terms
  • Supplier Qualification
  • BOM
  • Change Control
Industry
  • Consumer Products
  • Plastics & Resins
  • Chemicals

Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.

Keep reading

  • Global Consumer Product Safety Readiness Guide (2026)
  • ASTM F963-23 and EU Toy Safety Regulation 2025/2509: Readiness
  • California Prop 65 Warnings: Labels, Short Form, Online Sales and Supplier Notices
  • CPSIA Children's Product Certificate Readiness: Testing, Content and eFiling
  • EU General Product Safety Regulation (EU) 2023/988: Duties for Manufacturers and Importers
All guides

Showing the site for the United States. Local spelling, dates and prices are applied automatically; change the language at the top of the page.

V5 Ultimate
Ultimate

Warehouse, quality and manufacturing software for regulated operations.

ProductIndustriesPricingResourcesSecurity & TrustCompanyLegal Centre

© S.G. Systems, LLC

Page version 1.3· Last revised 5 Oct 2026