RoHS Compliance

‍RoHS Compliance refers to mandatory conformance with the Restriction of Hazardous Substances standards, which limit the use of specific regulated materials in manufactured products.

RoHS compliance is a key requirement in the purchasing and supplier quality standards, particularly when dealing with international supply chains and manufacturers (as implied by the medical device industry context in the source documents).

If a supplier is RoHS Compliant, they have met the standards regarding the composition of their product materials and have certified that restricted hazardous substances are either absent or limited to acceptable levels in the supplied components or finished goods.

RoHS (Restriction of Hazardous Substances) in Quality Management

RoHS is the European Union Directive 2011/65/EU (commonly called RoHS 2), as amended by Directive (EU) 2015/863 (RoHS 3), that restricts the use of specific hazardous substances in electrical and electronic equipment (EEE) placed on the EU market. Its primary goal is to reduce environmental and health risks posed by toxic materials in products and waste streams (especially during recycling and disposal) by requiring manufacturers to substitute safer alternatives.

In the context of Quality Management Systems (QMS) — such as ISO 9001, IECQ QC 080000 (Hazardous Substance Process Management), IATF 16949, or AS9100 — RoHS is treated as a mandatory regulatory compliance requirement and a core element of product environmental compliance.

RoHS directly impacts:

Design for Compliance (DfC) / Design for Environment (DfE) — Engineers must select RoHS-compliant materials/components from the earliest design stages.

Supply Chain Management — Suppliers must provide material declarations (e.g., IPC-1752A XML, IMDS, or BOMcheck FMDs) certifying that parts meet RoHS limits. Non-compliant suppliers are disqualified or require corrective action.

Risk Management & Non-Conformance Control — Potential RoHS violations are treated as quality risks (FMEA/PFMEA). Screening (XRF) and destructive testing are standard incoming/in-process controls.

Documentation & Traceability — RoHS conformity is part of the Technical Documentation File for CE marking. Companies maintain Declarations of Conformity (DoC) and evidence of due diligence.

Corrective Action / CAPA — RoHS failures trigger containment (quarantine/recall), root cause analysis, and systemic fixes.

Audits & Customer Requirements — Third-party certification (IECQ HSPM) or customer audits frequently verify RoHS processes. Metrics such as % compliant suppliers or RoHS PPM are common KPIs.

Non-compliance can lead to market bans, fines up to 10% of global turnover (under EU market surveillance), product recalls, and reputational damage. Even non-EU companies often adopt RoHS globally due to customer demands (Apple, Dell, etc., enforce it worldwide).

Current RoHS-Restricted Substances (10 substances as of December 2025)

The directive restricts the following substances in homogeneous materials (maximum concentration values by weight). No changes have been made to this list since the four phthalates were added in 2015 (effective 2019 for most categories):

Lead (Pb) Maximum allowed: 0.1 % (1 000 ppm)

Most commonly found in: solder, lead-acid batteries, glass (especially in older CRTs and crystal), PVC stabilisers, pigments, ceramic components, some aluminium alloys.

Mercury (Hg) Maximum allowed: 0.1 % (1 000 ppm)

Most commonly found in: fluorescent lamps, tilt switches, relays, some buttons and silent switches.

Cadmium (Cd) Maximum allowed: 0.01 % (100 ppm)

Most commonly found in: Ni-Cd batteries, plating, pigments (yellow/red), plastic stabilisers, older solder.

Hexavalent Chromium (Cr⁶⁺) Maximum allowed: 0.1 % (1 000 ppm)

Most commonly found in: chromate conversion coatings (yellow/gold passivation on zinc-plated parts), anti-corrosion treatments, some pigments.

Polybrominated Biphenyls (PBB) Maximum allowed: 0.1 % (1 000 ppm)

Historically used as flame retardants in plastics, printed circuit boards, housings (largely phased out since the 2000s).

Polybrominated Diphenyl Ethers (PBDE) Maximum allowed: 0.1 % (1 000 ppm)

Historically used as flame retardants in circuit boards, cables, plastic housings (also largely phased out).

Bis(2-ethylhexyl) phthalate (DEHP) Maximum allowed: 0.1 % (1 000 ppm)

Plasticiser used in PVC insulation for cables, flexible tubing, some adhesives and sealants.

Butyl Benzyl Phthalate (BBP) Maximum allowed: 0.1 % (1 000 ppm)

Plasticiser in PVC (cables, flooring, synthetic leather, adhesives).

Dibutyl Phthalate (DBP) Maximum allowed: 0.1 % (1 000 ppm)

Plasticiser in adhesives, inks, sealants, some nail polish and cosmetics (now restricted in many products).

Diisobutyl Phthalate (DIBP) Maximum allowed: 0.1 % (1 000 ppm)

Used as a substitute for DBP in similar applications – adhesives, inks, plasticisers.

These ten substances are the current RoHS-restricted list (RoHS 3). The limits apply to each homogeneous material in the product (i.e., you cannot average across the whole product). Exemptions exist for specific applications, but they are continually reviewed, and many are expiring or being tightened.

Certain applications are temporarily exempt (Annex III/IV), but exemptions are continuously reviewed, and many expire or are tightened (e.g., several lead exemptions were updated or revoked in 2025).

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