Phthalate Restrictions Worldwide: 12 Restricted Phthalates in 8 Jurisdictions

Twelve ortho-phthalates are restricted in at least one of eight jurisdictions, and the broadest single rule is REACH Annex XVII entry 51, which has limited DEHP, DBP, BBP and DIBP to 0.1 % by weight of the plasticised material in all articles sold in the EU since 7 July 2020. No jurisdiction restricts every phthalate, so which ones are caught, and where?

Two structural facts decide every answer on this page. Restrictions are written per substance and per product scope, not per chemical family, so one instrument can name three phthalates and leave nine untouched. The same substance can be prohibited above a threshold in a toy, limited by migration in a food-contact film and left unrestricted in an industrial cable, all within one jurisdiction. Phthalates are the largest plasticizer class among plastic additives, and the 43 families of plastic additives are described function by function on the reference page.

This page indexes which of the twelve restricted phthalates applies where, the eight jurisdictions in order of how binding their restriction is for an exporter, the substance-by-jurisdiction matrix, the mechanics of the 0.1 % limit, the restriction timeline from 1988 to 2030, what is still pending, what a compliance file has to document, and what replaces a restricted phthalate in a formulation. Every jurisdiction section names its own instrument and its own in-force date, because a phrase such as "banned" or "restricted" without an instrument and a date is not verifiable and is never used here on its own. The health science behind the restrictions, covered separately on phthalates: health effects and exposure, is summarised only where the legal reason for a restriction requires it.

Verified 22 September 2026. This table summarises. The limit that applies to a specific article is the one in the section below.

Regulatory status verified: 22 September 2026. This page is a technical reference on where and how ortho-phthalate plasticizers are restricted; it is not legal advice, and a compliance decision should be confirmed against the official text cited in each section.

Which Phthalates Are Restricted?#

The phthalates named in restrictions are ortho-phthalates, the dialkyl esters of benzene-1,2-dicarboxylic acid used as PVC plasticizers, and twelve of them are restricted somewhere in the world: DEHP, DBP, BBP, DIBP, DINP, DIDP, DNOP, DCHP, DPENP, DHEXP, DIOP and DIHP. The US EPA uses the equivalent term "dialkyl ortho-phthalate ester" for the same chemical class, and every regulation on this page restricts one or more members of it by name, never the family as a whole.

Why do restrictions split one chemical family into two groups? The split follows the length of the alcohol chain that forms the ester, because that length also predicts toxicity and regulatory treatment. Every one of the four phthalates with a harmonised reproductive-toxicity classification, DEHP, DBP, BBP and DIBP, sits in the short-chain group, while DINP and DIDP, both restricted only in specific product categories, sit in the long-chain group. The chemistry of the plasticizer class as a whole, alongside citrates, adipates and other classes, is compared on plasticizers for plastics.

Low-molecular-weight and high-molecular-weight phthalates#

Restrictions follow the molecular-weight split: the low-molecular-weight phthalates, with 3 to 6 carbon atoms in the alcohol chain backbone, carry harmonised reproductive-toxicity classifications and are the ones restricted in all articles, while the high-molecular-weight phthalates, with 7 to 13 carbon atoms, are restricted only in specific product groups. The carbon-number definition comes from European Plasticisers, the European industry association, which also reports that high-molecular-weight grades account for about 85 % of Western European ortho-phthalate production, against under 11 % for low-molecular-weight grades.

• Low-molecular-weight phthalates: DEHP, DBP, DIBP and BBP, with 3 to 6 carbon atoms in the alcohol chain. All four carry harmonised CLP reproductive-toxicity classifications.
• High-molecular-weight phthalates: DINP, DIDP, DPHP, DIUP and DTDP, with 7 to 13 carbon atoms in the alcohol chain. DINP carries no harmonised classification, following the RAC opinion of 9 March 2018.

The chemistry of both groups, with the full substance list, is on phthalate plasticizers.

Which phthalates carry no restriction#

Several phthalates carry no restriction in plastics in any of the eight jurisdictions, including DPHP, which is not an SVHC, is not on Annex XIV and is not named in REACH Annex XVII entries 51 or 52. Each "no restriction" statement below carries its own jurisdiction and instrument, because an unlisted substance in one register is not automatically unlisted in another.

• DPHP (di(2-propylheptyl) phthalate): not an SVHC, not on Annex XIV, not named in entries 51 or 52, and not on the EU food-contact Union list.
• DMP (dimethyl phthalate): carries no plastics restriction under any of the eight jurisdictions' instruments reviewed on this page.
• DEP (diethyl phthalate): carries no plastics restriction and remains authorised by FDA for food-contact use.
• DIDP and DNOP: sit outside 16 CFR 1307, the US federal children's-product limit, after the interim restriction on both was lifted.
• DIBP and DCHP: are not listed on the OEHHA Proposition 65 list, edition of 31 July 2026.

Is DOTP a phthalate?#

DOTP is chemically a phthalate ester but not an ortho-phthalate: it is the terephthalate isomer, CAS 6422-86-2, so none of the restrictions written for ortho-phthalates apply to it. DOTP holds FCM number 798 with an EU food-contact SML of 60 mg/kg, is not an SVHC and is not on the Proposition 65 list. DINCH, a cyclohexane-1,2-dicarboxylate, is likewise outside the ortho-phthalate restrictions for the same structural reason. Its identity, food-contact status and uses in plastics are on DOTP / DEHT (dioctyl terephthalate).

Phthalate Restrictions in 8 Jurisdictions#

Phthalate restrictions exist in eight jurisdictions: the European Union, the United States at federal level, California and the other US states, Canada, China, Japan, South Korea, and the food-contact regimes of India and Mercosur.

Each of these sits inside a wider set of plastic additive regulations that also covers stabilizers, flame retardants and pigments.

1. European Union: REACH, food contact, RoHS, toys and medical devices#

The European Union restricts phthalates through six instruments at once: REACH Annex XVII entries 51 and 52, the REACH Annex XIV authorisation requirement, the food-contact migration limits of Regulation (EU) No 10/2011 as amended by Regulation (EU) 2023/1442, RoHS Directive 2011/65/EU, the Toy Safety Regulation (EU) 2025/2509 and the Medical Device Regulation (EU) 2017/745. The REACH Annex XVII restrictions cover entries 23, 50, 51, 52, 63, 78 and 79 across every additive family, and entries 51 and 52 are the two that name phthalates. RoHS adds a narrower unit of measurement: DEHP, BBP, DBP and DIBP may not exceed 0.1 % per homogeneous material in electrical and electronic equipment, a rule that has applied since 22 July 2019 (categories 8 and 9 from 22 July 2021), under Delegated Directive (EU) 2015/863. The Medical Device Regulation adds a labelling and justification duty rather than a numeric limit: Annex I 10.4.2 requires a justification for any CMR or endocrine-disrupting substance above 0.1 % w/w in an invasive or fluid-contact device, and Annex I 10.4.5 requires it to be labelled on the device or its packaging.

Is phthalate banned in Europe?#

No phthalate is banned outright in the EU, and four come close: DEHP, DBP, BBP and DIBP may not exceed 0.1 % by weight of the plasticised material in any article placed on the EU market, while DINP, DIDP and DNOP are restricted only in toys and childcare articles that a child can put in the mouth. Fourteen phthalate entries also sit on the REACH Authorisation List, Annex XIV, where every sunset date has already passed, so any remaining EU use of those substances needs an authorisation. DINP is not banned in the EU: it carries no harmonised CLP classification and the risk assessment committee found none warranted for reproductive toxicity on 9 March 2018. The Candidate List is a notification and communication trigger, never a ban, and this page never calls it one.

REACH Annex XVII entries 51 and 52#

REACH Annex XVII entry 51 limits DEHP, DBP, BBP and DIBP to 0.1 % by weight of the plasticised material, individually or in any combination, in every article placed on the EU market, and it has applied to all articles since 7 July 2020 under Regulation (EU) 2018/2005. "Plasticised material" covers PVC, PVDC, PVA, polyurethane and any other polymer except silicone rubber and natural latex coatings, and the same limit reaches coatings, adhesives and inks used with those polymers; "prolonged skin contact" means more than 10 minutes of continuous contact or 30 minutes of intermittent contact per day. Entry 51 carries eight defined exemptions, each with its own qualifying condition.

• Articles for exclusively industrial or agricultural use.
• Outdoor-only articles, provided they involve no mucous-membrane contact and no prolonged skin contact.
• Aircraft and motor vehicles placed on the market before 7 January 2024, and their spare parts.
• Laboratory measuring devices.
• Food contact materials, which are instead governed by Regulation (EU) No 10/2011.
• Medical devices, which are instead governed by Regulation (EU) 2017/745.
• Electrical and electronic equipment, which is instead governed by the RoHS Directive.
• Immediate packaging of medicinal products.

Entry 52 is narrower in scope: DINP, DIDP and DNOP may not exceed 0.1 % in toys and childcare articles designed to be placed in the mouth, a rule in force since 16 January 2007 under Regulation (EC) No 552/2009, originally Directive 2005/84/EC.

REACH Annex XIV: 14 phthalate entries that need authorisation#

Fourteen phthalate entries sit on the REACH Authorisation List, Annex XIV, and every one of their sunset dates has passed, so any EU use of those substances needs an authorisation granted to a named user for a named use. Verified against the consolidated Annex XIV of 22 June 2026, the entries run from 4 to 7, 33 to 39 and 44 to 46: DEHP (entry 4), BBP (5), DBP (6) and DIBP (7) had a latest application date of 21 August 2013 and sunset on 21 February 2015; entries 33 to 39 sunset on 4 July 2020; entries 44 to 46 sunset on 27 February 2023. Regulation (EU) 2021/2045 added endocrine-disrupting properties to the relevant entries, with derogation dates of 14 June 2023 and 14 December 2024. DEHP in medical devices carries its own schedule under Regulation (EU) 2023/2482, with a latest application date of 1 January 2029 and a sunset date of 1 July 2030.

Authorisation is downstream of the SVHC Candidate List: Candidate List inclusion triggers the Article 33 communication and the Article 7(2) notification duties before an entry ever reaches Annex XIV, with DEHP, DBP and BBP included on 28 October 2008, DIBP on 13 January 2010, DCHP on 27 June 2018 and diisohexyl phthalate on 16 January 2020.

An Annex XIV entry does not expire automatically once its sunset date passes; it converts the substance from a restricted-content rule into an authorisation-only rule, so a use that was compliant on the sunset date itself becomes non-compliant the day after unless the Commission has already granted an authorisation for that specific use.

All fourteen entries and their sunset dates are set out entry by entry on REACH Annex XIV Authorisation List.

Food contact: the specific migration limits of Regulation (EU) 2023/1442#

In EU food-contact plastics the phthalate limits are specific migration limits, not content limits: DEHP 0.6 mg/kg, DBP 0.12 mg/kg and BBP 6 mg/kg of food since Regulation (EU) 2023/1442 entered into force on 1 August 2023. The older values of DEHP 1.5, BBP 30 and DBP 0.3 mg/kg are obsolete. DINP and DIDP share a group SML(T) of 1.8 mg/kg under group restriction 26, and a wider group restriction 36 caps DBP, DIBP, BBP and DEHP together at 0.6 mg/kg expressed as DEHP equivalents, weighted DBP x5, DIBP x4, BBP x0.1 and DEHP x1.

DEHP equivalents for group restriction 36 = DBP x5 + DIBP x4 + BBP x0.1 + DEHP x1. Basis: EFSA opinion of 18 September 2019, group tolerable daily intake 50 micrograms per kg body weight per day.

The full table is read alongside EU 10/2011, the regulation that sets the Union list, the overall migration limit and the declaration rules that apply to every listed additive, not only phthalates. The complete specific migration limits (SML) table for every listed additive, not only the phthalate group, is maintained separately.

2. United States: CPSC, FDA and EPA#

Three federal agencies restrict phthalates in the United States: the Consumer Product Safety Commission under 16 CFR 1307, the Food and Drug Administration under 21 CFR, and the Environmental Protection Agency under the Toxic Substances Control Act. No phthalate carries an "FDA approved" status; the correct wording is "authorised under 21 CFR 178.3740" for a stated set of conditions of use, because FDA authorisation of a food-contact substance is always conditional on the use, not a blanket safety finding. Each agency also works on a different regulatory instrument: CPSC sets a content limit for a defined product category, FDA sets conditions of use for a defined food-contact application, and EPA runs a risk-based review under TSCA that can lead to a use restriction years after the review itself is published.

Are phthalates banned in the US?#

No phthalate is banned across all US products: eight phthalates are prohibited above 0.1 % in children's toys and child care articles under 16 CFR 1307, eight remain authorised as food-contact plasticizers under FDA rules, and EPA has finished risk evaluations for seven of them without yet issuing a single risk-management rule. The FDA action of 27 May 2026 proposes a cumulative risk group for four phthalates and is a proposal, not a ban. The TSCA section 6(a) risk-management rules that would follow EPA's unreasonable-risk findings remain pending for all seven evaluated substances.

CPSIA 16 CFR 1307: the 8 phthalates limited in children's products#

16 CFR 1307.3 prohibits eight phthalates above 0.1 % in any accessible plasticised component of a children's toy or child care article: DEHP, DBP and BBP permanently under paragraph (a), and DINP, DIBP, DPENP, DHEXP and DCHP under paragraph (b) since 25 April 2018.

1. DEHP, paragraph 1307.3(a), permanent.
2. DBP, paragraph 1307.3(a), permanent.
3. BBP, paragraph 1307.3(a), permanent.
4. DINP, paragraph 1307.3(b), since 25 April 2018.
5. DIBP, paragraph 1307.3(b), since 25 April 2018.
6. DPENP, paragraph 1307.3(b), since 25 April 2018.
7. DHEXP, paragraph 1307.3(b), since 25 April 2018.
8. DCHP, paragraph 1307.3(b), since 25 April 2018.

The final rule was issued 27 October 2017 (82 FR 49982), effective 25 April 2018 and amended 23 July 2018 (83 FR 34764); the interim restrictions on DIDP and DNOP that applied before the final rule were lifted. A related rule, 16 CFR 1308, exempts polypropylene, polyethylene, general-purpose and impact polystyrene, and ABS containing listed additives from third-party phthalate testing, a distinction covered in full on CPSIA phthalate limits.

FDA food contact: 8 ortho-phthalates still authorised#

Eight ortho-phthalates remain authorised as food-contact plasticizers in the United States after the FDA final rule of 20 May 2022: DINP, DIDP, DEHP, DCHP, BPBG, DEP, EPEG and DIOP. That rule (87 FR 31080) removed 25 authorisations, 23 of them ortho-phthalates, on abandonment grounds after a petition from the Flexible Vinyl Alliance, and denied a related food additive petition (FAP 6B4815) the same day (87 FR 31066); the removals reflected the fact that the uses were no longer manufactured, not a new safety finding.

Under 21 CFR 178.3740, DINP is permitted up to 43 wt% of vinyl chloride polymers for food types I, II, IV-B and VIII at room temperature or below, in film 0.005 inch or thinner, and DCHP is permitted up to 10 % total phthalates as phthalic acid in PVAc or PVC film and sheet. The FDA's scientific evaluation of 27 May 2026 proposes DEHP, DCHP, DIOP and DINP as a cumulative risk group under docket FDA-2026-N-5776, with comments accepted to 26 July 2026; this is a proposed post-market assessment, not a rulemaking. Part by part, the CFR sections that carry additive limits are mapped on FDA food contact rules.

3. California and the other US states#

California does not ban phthalates: Proposition 65 requires a warning when exposure exceeds the safe-harbour level, and six phthalates are on the list, starting with DEHP in 1988 and DINP in 2013. DEHP was listed for cancer on 1 January 1988 and for developmental and male reproductive toxicity on 24 October 2003; DBP for developmental, female and male reproductive toxicity on 2 December 2005; BBP for developmental toxicity on 2 December 2005; DIDP for developmental toxicity on 20 April 2007; DINP for cancer on 20 December 2013, carrying a no significant risk level of 146 micrograms per day, revised 1 April 2016; and DnHP is listed. DIBP and DCHP are not on the OEHHA list of 31 July 2026. Short-form warning amendments took effect 1 January 2025, with a transition period to 1 January 2028. The full listing dates and safe-harbour levels for every additive, not only phthalates, are on California Proposition 65.

A Proposition 65 listing is a warning duty, not a content limit: a product may still be sold in California above the safe-harbour level, provided the label carries the required warning, which is the structural difference between Proposition 65 and every content-limit or migration-limit instrument named elsewhere on this page.

Outside California, Washington's Safer Products for Washington programme restricts ortho-phthalates in vinyl flooring under chapter 173-337 WAC, effective 1 January 2025. This restriction, alongside comparable rules in other states, is tracked together on US state laws on plastic additives.

4. Canada#

Canada's Phthalates Regulations, SOR/2016-188, cap six phthalates at 1,000 mg/kg in the vinyl of children's products, and they have applied since 22 June 2016. DEHP, DBP and BBP are capped at 1,000 mg/kg maximum in the vinyl of toys and child care articles, and DINP, DIDP and DNOP are capped at the same 1,000 mg/kg in the vinyl of parts that a child can place in the mouth; "toy" means for children under 14 years and "child care article" means for children under 4 years. The regulation and its companion instrument, the Toxic Substances Prohibitions, are set out on Canadian regulations for plastic additives.

5. China#

China controls phthalates in food-contact plastics through GB 9685-2016, the positive list for food-contact additives, issued 19 October 2016 and effective 19 October 2017, with about 1,294 permitted additives each carrying an SML, a QM, a detection limit and applicable group limits; Amendment No. 1 (XG1-2025) was approved 16 March 2025 and took effect immediately.

China also regulates phthalates in toys through GB 6675.1-4:2025, issued 5 October 2025, which applies to toys made or imported from 1 November 2026, with compliant stock manufactured under the earlier standard saleable until 31 October 2027. The specific phthalate limit values in GB 6675.1-4:2025 are not yet captured in our sources for this page, so this page states the application date and the toy scope only; the numeric limits should be read from the standard directly. The transition date matters for an exporter more than the limit values themselves at this stage, because stock produced to the outgoing standard has a fixed sell-through window and a shipment timed after 1 November 2026 must already meet the new standard. The food-contact list and its 2025 amendment are covered in full on China GB 9685 and GB 4806.

6. Japan#

Japan limits six phthalates in toys to 0.1 % by mass under MHLW Notification No. 336, which has applied since 6 September 2011, and bars DINP from PVC toy materials altogether. DEHP, DBP and BBP are limited to 0.1 % by mass maximum in designated toys, and DINP, DIDP and DNOP are limited to 0.1 % by mass in parts that a child can place in the mouth; the notification was issued 6 September 2010. These toy values are attributed to an SGS SafeGuardS bulletin, a secondary source summarising the notification. Japan's food-contact positive list, separate from the toy rule, came into force 1 June 2020 under Notification No. 196 of 28 April 2020, and a revised list, Notification No. 324 of 30 November 2023, applies from 1 June 2025. The positive list and its 2025 revision are on Japan positive list for food contact plastics.

7. South Korea#

South Korea tightens its DEHP limit from 27 March 2027: MFDS Notification No. 2026-24 of 27 March 2026 replaces the migration limit of 1.5 mg/L for PVC food-contact materials with a not-detected requirement. This secondary-sourced notification also sets DEHA at 18 mg/L, with a not-detected requirement specifically for cling wrap, both taking effect on the same 27 March 2027 date, while mechanically recycled polypropylene has been recognised for food-contact use since 27 March 2026. The MFDS migration limits for every material group are on Korea food contact standards.

8. India, Mercosur and the global treaties#

India controls phthalates only through a food-contact positive list: the Food Safety and Standards (Packaging) Regulations of 2018, notified 24 December 2018, set an overall migration limit of 60 mg/kg or 10 mg/dm2 under IS 9845, with colorants controlled separately under IS 9833 and polyethylene constituents under IS 10141, and toy-specific phthalate limits under IS 9873 are not yet captured in our sources for this page. The FSSAI packaging rules and the BIS standards are set out on India food contact and toy rules.

Mercosur regulates phthalates the same way, through a positive list rather than a substance-by-substance restriction: Mercosur GMC 39/19, GMC Resolution No. 39/19 sanctioned 15 July 2019, lists about 1,150 permitted additives with their specific migration limits, repealing the earlier GMC Resolution 32/07, and Brazil implemented it through ANVISA RDC 326/2019 of 3 December 2019, effective 180 days after publication. Amendments to Resolution 39/19 after 2019 are not yet verified against the primary text, so this page cites only the 2019 resolution and the Brazilian implementing rule.

No ortho-phthalate is a persistent organic pollutant under the Stockholm Convention: the plastics additives listed there are the brominated flame retardants PBDEs, HBCD, decaBDE and Dechlorane Plus, plus SCCP, MCCP, UV-328, PFOA and PFHxS. The wider Global Plastics Treaty process has not banned any additive either: INC-5.2 in Geneva, 5 to 15 August 2025, ended without agreement, INC-5.3 met on 7 February 2026 and elected Julio Cordano of Chile as Chair, and INC-5.4 is scheduled for 13 to 24 March 2027. What the negotiators could still list is followed on Global Plastics Treaty.

Phthalate Restriction Matrix: 12 Substances Across 8 Jurisdictions#

The matrix below gives each of the twelve restricted phthalates with its CAS number, its EU restriction, its EU authorisation status, its food-contact limit, its US children's-product status, its FDA food-contact status, its Proposition 65 listing and its Canadian and Japanese toy limits.

n/a means our source library holds no record for that jurisdiction, which is not the same as permitted. "Not listed" means the substance is not named in that instrument. DPENP, DHEXP and DIHP have no dedicated substance page and are shown here in plain text. Verified 22 September 2026.

Each substance links onward to a full regulatory matrix in the plastic additives database.

What the 0.1 % Limit Actually Applies To#

The 0.1 % in REACH Annex XVII entry 51 is 0.1 % by weight of the plasticised material in each component article, not 0.1 % of the finished product, so a phthalate-containing gasket inside an otherwise compliant appliance is assessed on its own. This reading comes from the Court of Justice of the European Union judgment C-106/14 of 10 September 2015, "once an article, always an article", which holds that a complex product is assessed component by component rather than as a single average. A compounder supplying a gasket compound at 0.3 % DEHP breaches entry 51 even if the finished appliance, averaged across all its parts, would calculate below 0.1 %.

Does the same 0.1 % mean the same thing under RoHS and under the food-contact rules? No: RoHS applies its own 0.1 % threshold per homogeneous material, a narrower and stricter unit than the "article" used in entry 51, because a homogeneous material is a single substance or a mixture that cannot be mechanically disjointed into separate materials, and a plasticised gasket that is itself one homogeneous material must meet the limit on its own composition. Food-contact limits work on a different principle again: they are migration limits in milligrams per kilogram of food, not content limits on the material, so a plastic can legally contain more than 0.1 % DEHP by weight and still comply with Regulation (EU) No 10/2011 provided the substance migrates into food below its specific migration limit. A single cable jacket compound can therefore pass entry 51 on an article basis, fail RoHS on a homogeneous-material basis and never be tested against a food-contact migration limit at all, because the three units, the article, the homogeneous material and the food-contact migration test, measure three different things and are never interchangeable.

Candidate List inclusion adds documentation duties that apply above the same 0.1 % threshold but independently of any restriction. A supplier must issue an Article 33 communication to a professional recipient whenever an article contains a Candidate List substance above 0.1 % by weight, and must answer a consumer's request for the same information within 45 days. A company placing more than 1 tonne per year of an article containing the substance above 0.1 % must also submit an Article 7(2) notification to ECHA within 6 months of the substance's Candidate List inclusion, and, since 5 January 2021, notify the same information to the SCIP database.

Phthalate Restriction Timeline: 1988 to 2030#

Phthalate restriction started with a single Californian cancer listing in 1988 and now runs to a scheduled EU medical-device sunset date in 2030.

What Is Pending and What Changes Next#

Six phthalate actions are pending: an FDA cumulative safety assessment, seven TSCA risk-management rules, China's new toy limits, Korea's not-detected requirement, ECHA's proposed REACH restriction on ortho-phthalate plasticisers in PVC, and the EU Toy Safety Regulation. None of these is written on this page as already in force; each is proposed, pending or scheduled to apply from a future date.

Every one of these actions is reported on the day it is published in plastic additives news.

What Do You Have to Document?#

Five documents carry a phthalate claim through a supply chain: the supplier declaration for the compound, the safety data sheet for the additive, the REACH Article 33 communication for any article above 0.1 %, the SCIP notification, and the declaration of compliance for food-contact use.

1. Obtain the supplier declaration for the plasticizer compound, confirming the phthalate identity and its content.
2. Keep the safety data sheet for the additive current with its CLP classification.
3. Issue a REACH Article 33 communication to recipients whenever a component article contains a Candidate List phthalate above 0.1 % by weight, and answer a consumer request within 45 days.
4. File the SCIP notification to ECHA's database, a duty in force since 5 January 2021, for any article containing a Candidate List substance above 0.1 %.
5. Provide the declaration of compliance for food-contact use, stating the specific migration limits and the conditions of use claimed under Regulation (EU) No 10/2011.

The test methods that verify a phthalate content claim, CPSC-CH-C1001-09.4, EN 14372 and IEC 62321-8, are named here only to route the reader; the methods themselves are described on phthalate testing in plastics.

None of these five documents is optional once a phthalate crosses the 0.1 % threshold in an article or is present as a food-contact plasticizer, because a missing communication, notification or declaration is itself a compliance failure independent of whether the underlying substance content is within limit.

Every field the declaration of compliance (DoC) must contain for a food-contact article is listed separately, beyond the phthalate-specific fields covered here.

What Replaces a Restricted Phthalate?#

Four substance classes replace restricted ortho-phthalates in flexible PVC: terephthalates such as DOTP, cyclohexanoates such as DINCH, trimellitates such as TOTM for high-temperature cable, and bio-based esters such as ATBC and epoxidised soybean oil. Each survives the current restrictions for a specific regulatory reason rather than a blanket "safer" classification: non-phthalate plasticizers compares their performance, cost and availability class by class. Flexible PVC carries 5 to 65 wt% plasticizer, so a replacement is loaded at the same order of magnitude as the phthalate it displaces, not as a minor additive.

The medical case carries the most exact substitution data available. Bernard and colleagues, in a 2018 study in PLoS One measuring plasticizer content in French PVC medical lines, found TOTM at 30 to 41 wt%, DEHT at 26.7 to 37.5 wt%, DINCH at 30.2 to 44.3 wt% and DINP at 34.9 to 48.7 wt% across the sampled tubing sets, showing that replacement grades are loaded in the same range as the DEHP they displace, not at a fraction of it. DEHP itself remains usable in EU medical devices under its Annex XIV authorisation until the sunset date of 1 July 2030. MDR Annex I 10.4, the DEHP authorisation and ISO 10993 are covered on plastic additives in medical devices.

Why Are Phthalates Restricted?#

Phthalates are restricted because of individual classifications, not because of a finding about the family: DEHP, DBP, BBP and DIBP carry harmonised CLP classifications for reproductive toxicity, DEHP, DBP, BBP, DIBP and DCHP were additionally identified as endocrine disruptors under REACH Article 57(f), and DINP carries no harmonised classification at all. The scientific basis behind these classifications, together with the exposure data, is set out separately on phthalates: health effects and exposure, which this page hands the reader to for the studies and the dietary and consumer-product questions that fall outside a plastics-restriction reference.

Does all plastic contain phthalates?#

No: phthalates are plasticizers, so they occur in flexible PVC, which contains 5 to 65 wt% plasticizer, and not in polyethylene, polypropylene, PET, polystyrene or rigid PVC, which are used unplasticized. Western European phthalate production runs to about 1 million tonnes a year, of which more than 900,000 tonnes go into PVC, according to European Plasticisers, the European industry association; the remainder serves smaller plasticized-polymer applications. The full package a PVC compound needs, of which the plasticizer is one component among stabilizers and fillers, is on additives for PVC.

Which phthalates are endocrine disruptors?#

Five phthalates are formally identified as endocrine disruptors in the EU under REACH Article 57(f): DEHP, DBP, BBP, DIBP and DCHP, with DEHP and DBP identified for both human health and the environment and BBP, DIBP and DCHP identified for human health only. The human-health ground for DEHP, DBP, BBP and DIBP comes from Commission Implementing Decision (EU) 2017/1210 of 4 July 2017, and DBP gained the environmental ground on 23 January 2024. The CLP endocrine-disruptor hazard classes introduced by Delegated Regulation (EU) 2023/707 apply to substances from 1 May 2025 and to mixtures from 1 May 2026, adding a labelling layer on top of the Article 57(f) identification. How the identification is made, and which other additives carry it, is on endocrine disruptors in plastics.

What happens to phthalates already in products and in recyclate?#

Restricted phthalates keep circulating in recyclate: in 151 new PVC floorings sampled in Switzerland in 2021 and 2022, Wiesinger and colleagues at ETH Zurich, in a 2024 study in Environmental Science and Technology, found restricted ortho-phthalates in 21 % of samples and other, unrestricted ortho-phthalates in a further 29 %, with 16 % of all samples containing regulated chemicals, mainly lead and DEHP, above 0.1 wt% and linked to recycled PVC content. How much legacy content the measurements find across other additive classes, not only phthalates, is on legacy additives in recycled plastic.

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