--- title: "EU RoHS Phthalates: DEHP, BBP, DBP, DIBP" canonical_url: "https://www.sorena.io/artifacts/eu/rohs-directive/phthalates" source_url: "https://www.sorena.io/artifacts/eu/rohs-directive/phthalates" author: "Sorena AI" description: "source-linked RoHS guide to DEHP, BBP, DBP, and DIBP: 0.1% homogeneous-material limits, 2019 and 2021 application dates, exemptions, evidence, and testing standards." published_at: "2026-05-09" updated_at: "2026-05-09" keywords: - "EU RoHS phthalates" - "DEHP RoHS" - "BBP RoHS" - "DBP RoHS" - "DIBP RoHS" - "RoHS 0.1%" - "Directive 2011/65/EU" - "EU RoHS Directive" - "RoHS phthalates" - "DEHP" - "BBP" - "DBP" - "DIBP" --- **[SORENA](https://www.sorena.io/)** - AI-Powered GRC Platform [Home](https://www.sorena.io/) | [Solutions](https://www.sorena.io/solutions) | [Artifacts](https://www.sorena.io/artifacts) | [About Us](https://www.sorena.io/about-us) | [Contact](https://www.sorena.io/contact) | [Portal](https://app.sorena.io) --- # EU RoHS Phthalates: DEHP, BBP, DBP, DIBP source-linked RoHS guide to DEHP, BBP, DBP, and DIBP: 0.1% homogeneous-material limits, 2019 and 2021 application dates, exemptions, evidence, and testing standards. *Artifact Guide* *EU* ## EU RoHS Directive Phthalates EU RoHS restricts four phthalates in electrical and electronic equipment: Bis(2-ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP), Dibutyl phthalate (DBP), and Diisobutyl phthalate (DIBP). Use this page to check the 0.1% homogeneous-material limits, application dates, cable and spare-part rules, toy overlap, and the evidence needed for a RoHS technical file. For EU RoHS, phthalate compliance is not a generic chemical statement. It is a material-level check for DEHP, BBP, DBP, and DIBP in EEE placed on the Union market, tied to Annex II concentration limits, product category timing, any applicable exemptions, technical documentation, and CE conformity records. ## Which phthalates are restricted under EU RoHS? Commission Delegated Directive (EU) 2015/863 amended RoHS Annex II to add four phthalates to the restricted-substance list: Bis(2-ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP), Dibutyl phthalate (DBP), and Diisobutyl phthalate (DIBP). The current consolidated Directive 2011/65/EU lists each of those four phthalates with a maximum concentration value of 0.1% by weight in homogeneous materials. RoHS defines a homogeneous material as a uniform material, or a combination of materials that cannot be separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding, or abrasive processes. - Do not assess phthalates only at finished-product or component level; the Annex II limits apply by weight in homogeneous materials. - Record the full substance names and abbreviations: DEHP, BBP, DBP, and DIBP. - Keep the phthalate review separate from lead, mercury, cadmium, hexavalent chromium, PBB, and PBDE checks, even when the evidence is stored in the same RoHS file. Sources for this answer: - [Directive 2011/65/EU consolidated text, Annex II](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Binding consolidated RoHS source for homogeneous-material limits and the current Annex II restricted-substance list. - [Commission Delegated Directive (EU) 2015/863](https://data.europa.eu/eli/dir_del/2015/863/oj?ref=sorena.io) - Official amendment that added DEHP, BBP, DBP, and DIBP to RoHS Annex II. ## Application dates and carve-outs to check first Member States were required to apply the provisions introduced by Delegated Directive (EU) 2015/863 from 22 July 2019. Annex II gives a later phthalate date for medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments: 22 July 2021. Annex II also narrows how the phthalate restrictions apply to certain cables and spare parts. The restriction of DEHP, BBP, DBP, and DIBP does not apply to cables or spare parts used for repair, reuse, updating functionalities, or upgrading capacity of EEE placed on the market before 22 July 2019, or of medical devices and monitoring and control instruments placed on the market before 22 July 2021. - For most EEE, check whether the product was placed on the market on or after 22 July 2019. - For medical devices and monitoring and control instruments, check whether the relevant placement date is on or after 22 July 2021. - For cable and spare-part decisions, document the original EEE category, original market-placement date, and whether the part is for repair, reuse, functionality updates, or capacity upgrades. - For toys, Annex II says the RoHS restriction of DEHP, BBP, and DBP does not apply where those substances are already subject to REACH Annex XVII entry 51. Sources for this answer: - [Commission Delegated Directive (EU) 2015/863](https://data.europa.eu/eli/dir_del/2015/863/oj?ref=sorena.io) - Primary source for the 22 July 2019 application date, 22 July 2021 medical and monitoring date, cable and spare-part carve-outs, and toy overlap language. - [Directive 2011/65/EU consolidated text, Article 4 and Annex II](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Consolidated RoHS source for EEE scope, cables, spare parts, medical-device and monitoring-instrument timing, and Annex II phthalate restrictions. ## Evidence for a RoHS phthalate technical file A useful phthalate file should let a reviewer trace every conclusion from the homogeneous material to the placed-on-market product. Start with the bill of materials, polymer and plasticised-material declarations, supplier declarations, material risk screening, and any test reports used to support the DEHP, BBP, DBP, and DIBP conclusion. Directive 2011/65/EU requires manufacturers to draw up technical documentation, carry out internal production control, draw up an EU declaration of conformity when compliance is demonstrated, affix CE marking, and keep the technical documentation and EU declaration of conformity for 10 years after the EEE has been placed on the market. Importers must keep a copy of the EU declaration of conformity for 10 years after placing the EEE on the market and ensure that technical documentation can be made available on request. - Link each declaration or test report to a specific material, part number, supplier, revision, and product configuration. - Use EN IEC 63000:2018 as the harmonised technical-documentation reference where the file relies on harmonised-standard presumption of conformity. - Use IEC 62321-8:2017 where phthalate determination in polymers is needed; the IEC page identifies GC-MS and Py-TD-GC-MS techniques for DIBP, DBP, BBP, DEHP, DNOP, DINP, and DIDP in polymers of electrotechnical products. - Reopen the evidence file after supplier, polymer formulation, material colorant, plasticiser, cable, enclosure, or spare-part changes. Sources for this answer: - [Directive 2011/65/EU consolidated text, Articles 7, 9, 13, 15, and 16](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Binding source for manufacturer, importer, EU declaration, CE marking, and presumption-of-conformity obligations. - [Commission Implementing Decision (EU) 2020/659 on EN IEC 63000:2018](https://data.europa.eu/eli/dec_impl/2020/659/oj?ref=sorena.io) - Official source publishing EN IEC 63000:2018 for RoHS technical documentation in the Official Journal. - [IEC 62321-8:2017 phthalates in polymers](https://webstore.iec.ch/en/publication/32719?ref=sorena.io) - IEC source for phthalate determination in polymers by GC-MS and Py-TD-GC-MS methods. *Recommended next step* *Placement: after implementation section* ## Use this RoHS guide as a cited evidence workflow Turn this EU RoHS Directive page into a repeatable workflow for product, legal, quality, procurement, support, and engineering teams. Keep citations, owners, evidence, and review triggers together. - [Open Research Copilot](/solutions/research-copilot.md): Answer RoHS scope, timing, and interpretation questions with cited outputs. - [Talk through implementation](/contact.md): Review your scope, evidence model, controls, and next actions. ## Exemptions and mistakes that create weak RoHS answers Do not treat a RoHS exemption as a blanket permission for phthalates. Article 5 exemption logic is application-specific, limited in time, and tied to Annex III or Annex IV wording. The Commission implementation page states that exemption renewals should be filed no later than 18 months before expiry and that existing exemptions with a renewal request remain valid until the Commission decides. For phthalates, the first screening question is still Annex II: which homogeneous materials contain DEHP, BBP, DBP, or DIBP, at what concentration, and under which product timing rule? Only after that should the team assess whether a cable, spare-part, toy, or Annex III/IV exemption pathway changes the conclusion. - Do not cite a supplier's broad RoHS certificate unless it identifies the product, material scope, restricted phthalates, revision, and date. - Do not use a product-level percentage to answer a homogeneous-material limit. - Do not assume the 22 July 2021 date applies to all EEE; Annex II reserves that later date for medical devices and monitoring/control instruments. - Do not rely on an expired or pending exemption without documenting the exact Annex entry, renewal status, and Commission timing rule. Sources for this answer: - [European Commission RoHS Directive implementation](https://environment.ec.europa.eu/topics/waste-and-recycling/rohs-directive/rohs-directive-implementation_en?ref=sorena.io) - Commission implementation source for exemption limits, renewal timing, and evaluation process. - [Directive 2011/65/EU consolidated text, Article 5 and Annex V](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Binding source for exemption criteria and information required in exemption applications. - [Commission Delegated Directive (EU) 2015/863](https://data.europa.eu/eli/dir_del/2015/863/oj?ref=sorena.io) - Primary source for phthalate transition rules and the REACH toy-overlap clause. ## Primary sources - [Directive 2011/65/EU consolidated text, RoHS](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0065-20250101&ref=sorena.io) - Binding consolidated RoHS source for scope, Article 4 restrictions, homogeneous-material definition, Annex II phthalate limits, technical documentation, EU declaration of conformity, CE marking, and exemptions. - Quote: "Restricted substances referred to in Article 4(1)" - [Commission Delegated Directive (EU) 2015/863](https://data.europa.eu/eli/dir_del/2015/863/oj?ref=sorena.io) - Official amendment adding DEHP, BBP, DBP, and DIBP to RoHS Annex II and setting application dates and carve-outs. - Quote: "Bis(2-ethylhexyl) phthalate (DEHP) (0,1 %)" - [Commission Implementing Decision (EU) 2020/659 on EN IEC 63000:2018](https://data.europa.eu/eli/dec_impl/2020/659/oj?ref=sorena.io) - Official source for publication of EN IEC 63000:2018 as the RoHS technical-documentation harmonised standard. - Quote: "EN IEC 63000:2018" - [IEC 62321-8:2017 phthalates in polymers](https://webstore.iec.ch/en/publication/32719?ref=sorena.io) - IEC source for determination of selected phthalates in polymers of electrotechnical products by GC-MS and Py-TD-GC-MS. - Quote: "Determination of certain substances in electrotechnical products - Part 8" - [European Commission RoHS Directive implementation](https://environment.ec.europa.eu/topics/waste-and-recycling/rohs-directive/rohs-directive-implementation_en?ref=sorena.io) - Commission implementation source for exemption procedure, renewal timing, and assessment workflow. - Quote: "An application for renewal of an exemption shall be made no later than 18 months" ## Related Topic Guides - [Are cables in scope of EU RoHS? 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[EU RoHS Applicability Test for EEE Scope](/artifacts/eu/rohs-directive/applicability-test.md): Decide whether EU RoHS applies to electrical and electronic equipment, cables, spare parts, exclusions, exemptions, CE marking, and evidence records. - [EU RoHS CE Marking and Declaration of Conformity](/artifacts/eu/rohs-directive/ce-and-doc.md): source-linked guide to RoHS CE marking, EU Declaration of Conformity, technical documentation, EN IEC 63000, and importer or distributor checks. - [EU RoHS compliance checklist for EEE](/artifacts/eu/rohs-directive/checklist.md): Checklist for EU RoHS scope, restricted substances, homogeneous materials, exemptions, CE marking, technical documentation, and supplier evidence. - [EU RoHS Compliance Guide for EEE](/artifacts/eu/rohs-directive/compliance.md): Practical EU RoHS compliance guide for electrical and electronic equipment: scope, restricted substances, exemptions, CE marking, technical documentation, and supplier evidence. - [EU RoHS Deadlines and Compliance Calendar](/artifacts/eu/rohs-directive/deadlines-and-compliance-calendar.md): source-linked RoHS calendar for scope phase-ins, phthalate dates, exemption renewals, spare-parts cutoffs, EN IEC 63000, CE files, and review triggers. - [EU RoHS Declarations vs Lab Tests FAQ](/artifacts/eu/rohs-directive/faq/declarations-vs-lab-tests.md): When supplier declarations can support EU RoHS technical documentation, when IEC 62321 lab testing is stronger evidence, and how to document the decision. - [EU RoHS Directive FAQ: scope, substances, CE marking](/artifacts/eu/rohs-directive/faq.md): Practical EU RoHS Directive FAQ covering EEE scope, Annex II substance limits, cables, spare parts, technical documentation, CE marking, and exemptions. - [EU RoHS EEE Categories and Open Scope](/artifacts/eu/rohs-directive/eee-categories-and-open-scope.md): Map products to EU RoHS EEE categories, category 11 open scope, Article 2 exclusions, cables, spare parts, and evidence needed for RoHS scope decisions. - [EU RoHS for medical devices and monitoring equipment](/artifacts/eu/rohs-directive/medical-devices-and-monitoring-equipment.md): RoHS category 8 and 9 guide covering application dates, Annex IV exemptions, phthalates, spare parts, CE marking, declarations, and technical documentation. - [EU RoHS penalties and fines: Member State sanctions](/artifacts/eu/rohs-directive/penalties-and-fines.md): source-linked guide to EU RoHS penalty exposure: national sanctions, no EU-wide fine table, CE marking misuse, corrective actions, recalls, and evidence records. - [EU RoHS requirements for EEE, substances, and CE evidence](/artifacts/eu/rohs-directive/requirements.md): Practical EU RoHS requirements guide covering EEE scope, Annex II substance limits, exemptions, technical documentation, EU declaration of conformity, CE marking, and operator evidence. - [EU RoHS Restricted Substances and Thresholds | Annex II Limits](/artifacts/eu/rohs-directive/restricted-substances-and-thresholds.md): EU RoHS Annex II restricted substances and maximum concentration values by weight in homogeneous materials, including cadmium's 0.01% limit and the 0.1% limits for lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP. - [EU RoHS Spare Parts: Repair and Reuse](/artifacts/eu/rohs-directive/spare-parts.md): source-linked RoHS spare-parts guide covering Article 4 repair parts, reused recovered parts, closed-loop conditions, phthalate carve-outs, CE evidence, and cutoff dates. - 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