- Source for the amendment adding DEHP, BBP, DBP, and DIBP to the Annex II restricted-substance list.
"amending Annex II"
This test helps decide whether a product is electrical and electronic equipment in scope of Directive 2011/65/EU, or whether a specific exclusion, spare-part rule, cable rule, or exemption changes the RoHS answer.
The useful output is a documented scope conclusion tied to the product, EU role, restricted substances, technical documentation, declaration of conformity, and review triggers.
Structured answer sets in this page tree.
Cited legal and guidance references.
A RoHS applicability test starts with the exact article being supplied in the EU. Identify whether it is EEE, whether it falls into an Annex I category, whether Article 2 exclusions apply, and whether the finished product, cables, spare parts, or homogeneous materials must satisfy Article 4 substance restrictions and Article 7 documentation duties.
Directive 2011/65/EU applies to electrical and electronic equipment in the Annex I categories. EEE is equipment dependent on electric currents or electromagnetic fields to work properly, or equipment for generating, transferring, or measuring those currents or fields, within the Directive's voltage limits.
The first decision should be product-specific. Record the finished product, intended function, voltage rating, whether electricity or electromagnetic fields are needed for at least one intended function, and the Annex I category. The category matters for exemptions and transition points, but after the open-scope expansion most non-excluded EEE must be treated as in scope.
Article 2(4) excludes specific equipment types, including military/security equipment, space equipment, certain equipment specifically designed for excluded equipment, large-scale stationary industrial tools, large-scale fixed installations, means of transport other than non-type-approved electric two-wheel vehicles, professional non-road mobile machinery, active implantable medical devices, certain photovoltaic panels, business-to-business R&D equipment, and pipe organs.
Cables and spare parts need a separate check. Article 4 covers EEE placed on the market, including cables and spare parts for repair, reuse, updating functionality, or upgrading capacity. The Directive also contains specific spare-part and cable carve-outs tied to the date and type of original equipment.
If the item is in scope, Article 4 points to Annex II maximum concentration values by weight in homogeneous materials. The current consolidated Annex II lists lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP at 0.1%, and cadmium at 0.01%. A homogeneous material is assessed at material level, not at finished-product average level.
Exemptions are not general waivers. Article 4(6) points to Annex III and Annex IV applications, and Article 5 sets time-limited exemption procedures. An applicability record should identify the exact exemption entry, product category, substance, application wording, expiry status, and any renewal dependency rather than saying only that the product is RoHS exempt.
For in-scope EEE, the manufacturer must draw up technical documentation, carry out or have carried out the internal production control procedure, draw up an EU declaration of conformity when compliance is demonstrated, affix the CE marking, and keep the technical documentation and declaration for 10 years after placing the EEE on the market.
Importers and distributors also have RoHS checks. Importers must place only compliant EEE on the Union market and verify that the manufacturer has carried out conformity assessment, drawn up technical documentation, provided CE marking, and supplied required documents. Distributors must act with due care, including checking CE marking and required documents before making EEE available.
Use the applicability result to decide whether the next artifact is a RoHS technical file, an exemption register, a supplier evidence request, or an out-of-scope rationale tied to Article 2.
Check RoHS scope, exclusions, exemptions, and documentation questions against cited source material.
Review EEE classification, supplier evidence, exemptions, and technical documentation before shipment.
Weak RoHS records usually fail because they stop at a broad label such as electronic product, spare part, supplier declared, or CE marked. The applicability decision has to show why the specific article is in scope, excluded, exempted, or covered by a dated transition or spare-part rule.
The record should also keep RoHS separate from adjacent regimes. RoHS substance restrictions can overlap with REACH, POPs, batteries, WEEE, Low Voltage, EMC, and sector legislation, but each regime has its own trigger and evidence. A RoHS conclusion should not imply that those other duties are resolved.
"amending Annex II"
"EN IEC 63000:2018"
"no more than the maximum concentration value"
"case-by-case basis"
"Exemptions are limited in time"
"specifies the technical documentation"