Plastic Additive Regulations: Global Compliance Guide to 49 Rules in 5 Layers

Regulatory status verified: 22 September 2026.

Plastic additive regulations control the additive as a chemical substance, not as part of the plastic, and they arrive in 5 layers: chemical control, global treaties, food contact, product rules, and waste and degradability rules. This section indexes 49 of those instruments, spanning the European Union, United States federal law, United States state law, Canada, China, Japan, Korea, India, Mercosur and the Stockholm Convention. A compounder who buys one antioxidant meets several of those layers at the same time, so which layer bites first?

The layer that bites first is the one deciding whether the substance may exist in the supply chain at all. Chemical control comes from REACH, Regulation (EC) No 1907/2006, and from the Toxic Substances Control Act in the United States. Global treaties come from the Stockholm Convention and its European implementation, Regulation (EU) 2019/1021. Food contact comes from Regulation (EU) No 10/2011 and 21 CFR parts 174 to 178. Product rules come from the PPWR, Regulation (EU) 2025/40, and RoHS, Directive 2011/65/EU. Waste and degradability rules come from Regulation (EU) 2022/1616 and the oxo-degradable ban in Directive (EU) 2019/904. Under all of them the additive is a substance, the compound or masterbatch that carries it is a mixture, and the moulded part is an article.

This guide sets out which laws apply to a plastic additive, the 5 layers in order, the complete list of all 49 regulation guides, the rules jurisdiction by jurisdiction, which additives are genuinely restricted and under which entry number, what changed in 2026 and what changes next, how compliance is documented, and where each polymer's regulatory pressure point sits. Every value below names its instrument and its date, and the regulatory status of this page is verified as of 22 September 2026. This is a technical reference, not legal advice; check the official text before you rely on a value.

The 5 layers differ in what they act on, which instruments carry them and which additive they reach first, and the table below sets those differences side by side before each layer is explained in turn.

Counts are the regulation guides published in this section; the total is 49.

Which Laws Apply to a Plastic Additive?#

Three different legal objects sit inside one plastic part: the additive is a substance, the masterbatch or compound that carries it is a mixture, and the finished part is an article, and each object attracts a different set of duties under European and United States chemicals law. REACH, Regulation (EC) No 1907/2006, defines all three and attaches registration to the substance, classification and the safety data sheet to the mixture, and communication and notification duties to the article. A single antioxidant therefore appears three times in the same supply chain with three different legal identities.

Substances are what the law actually counts, and the 43 families of plastic additives described function by function on the reference page, from plasticizers and antioxidants through heat stabilizers, UV stabilizers, flame retardants, impact modifiers and fillers to pigments, are all substances in that sense. An additive imported inside a masterbatch is imported in a mixture, and its component substances must still be registered. The article layer adds a threshold rather than a list: the 0.1 % by weight trigger for substance-of-very-high-concern duties applies to each component article and not to the assembled product, which the Court of Justice of the European Union settled in Case C-106/14 on 10 September 2015, the judgment the industry calls "once an article, always an article".

Why an additive is regulated as a substance, not as a plastic#

Polymers are exempt from REACH registration under Article 2(9), so the regulatory weight falls on the additives: every additive is a substance and must be registered at 1 tonne a year or more per manufacturer or importer. The polymer that makes up 95 % of a compound carries no registration dossier, no tonnage band and no chemical safety report of its own. The 5 % that makes the compound usable carries all of them.

That asymmetry explains the shape of every dossier a compounder receives. The hazard data, the exposure scenarios and the classification that travel with a plastic compound describe its additives, not its resin, which is why a restriction on a plastic almost always arrives as a restriction on one of its additives. Polymer registration is not an upcoming obligation either: the full REACH revision that would have introduced it was set aside by the European Commission on 27 April 2026, so the substance-level model described here is the model in force.

Which rules attach to the substance, the compound and the finished article#

Four duties follow automatically when an additive enters the SVHC Candidate List: communication to recipients, notification to ECHA, a SCIP entry and a safety data sheet on request. Each duty has its own threshold, its own deadline and its own legal basis, and each is listed below.

• Communication to recipients, under REACH Article 33, applies to any article containing the substance above 0.1 % by weight and takes effect immediately on inclusion, with consumer requests answered within 45 days.
• Notification to ECHA, under REACH Article 7(2), applies above 0.1 % by weight and above 1 tonne a year per actor, and must be made within 6 months of inclusion.
• SCIP database notification applies to any article above 0.1 % by weight and has been required since 5 January 2021 under Article 9(1)(i) of the Waste Framework Directive.
• A safety data sheet on request applies to a non-classified mixture containing 0.1 % or more of the substance, under REACH Article 31(3).

None of those duties forbids the use of the additive. Every additive on the SVHC Candidate List, with its inclusion date and the property that put it there, is tabulated separately, and a compounder who reads that list as a ban list will withdraw products it does not need to withdraw. The threshold that matters is the per-article 0.1 %, so a 2-gram grommet inside a 5-kilogram appliance is assessed on its own weight.

Do plastic additives have to be registered under REACH?#

Yes: a plastic additive must be registered under REACH at 1 tonne a year or more per manufacturer or importer, and the duty follows the additive even when it arrives inside an imported masterbatch. The masterbatch is a mixture, and the substances in a mixture are registered individually by whoever manufactures or imports them in the European Union. Polymers themselves are exempt under Article 2(9), so the resin in the same shipment carries no registration. An importer who buys a finished compound therefore registers its additives, not its base polymer.

Is there such a thing as an FDA approved plastic additive?#

No: the FDA does not approve plastic additives, and "FDA approved" has no legal meaning for a food-contact substance. Neither does "food grade". The two defensible statements are that a grade complies with a named regulation, for example "complies with 21 CFR 178.2010 for olefin polymers, conditions of use B to H", or that it is the subject of an effective Food Contact Notification, for example "subject of effective FCN No. X". An FCN is effective only for the manufacturer named in it, so a second supplier of the same chemical cannot rely on it.

The 5 Layers of Plastic Additive Regulation#

The 49 rules that govern plastic additives fall into 5 layers: chemical control, global treaties, food contact, product rules, and waste and degradability rules. The order is the order in which a formulator normally meets them, from the substance itself to the end of the article's life.

Each layer answers a different question. Layer 1 asks whether the substance may be made and sold at all, layer 2 whether it must be eliminated worldwide, layer 3 whether it may touch food, layer 4 whether it may go into one particular product type, and layer 5 what happens to it in recyclate and in a degradability claim. An additive can pass 4 layers and fail the fifth, which is how a plasticizer that is lawful in a garden hose becomes unlawful in a teething ring.

1. Chemical control: registration, candidate lists and restrictions#

Chemical-control rules decide whether an additive may be made, imported or used at all, and they work on the substance wherever it ends up: REACH and CLP in the European Union, the Toxic Substances Control Act in the United States. REACH runs four processes in sequence: registration at 1 tonne a year, evaluation, authorisation of substances meeting the Article 57 criteria through the Article 59 Candidate List and Annex XIV, which holds 59 entries, and restriction through Annex XVII, whose entries are numbered up to 83, the most recent being entry 83 for 2,4-dinitrotoluene under Regulation (EU) 2026/859. The Candidate List grows in two batches a year, in January and June; the current total and the last inclusion date are on our SVHC page.

Registration thresholds, evaluation and the authorisation route are set out in full on REACH and plastic additives. The Annex XVII entries that reach plastic additives are entry 20 for organotin compounds at 0.1 % tin, entry 23 for cadmium below 0.01 % cadmium, entry 50 for polycyclic aromatic hydrocarbons in rubber and plastic parts with skin or mouth contact at 1 mg/kg each and 0.5 mg/kg in toys and childcare articles, entry 51 for DEHP, DBP, BBP and DIBP at 0.1 % of the plasticised material in all articles since 7 July 2020, entry 52 for DINP, DIDP and DNOP at 0.1 % in mouthable toys and childcare articles, entry 63 for lead in PVC below 0.1 % since 29 November 2024, entry 68 for C9 to C14 perfluorocarboxylic acids, entry 70 for the siloxanes D4, D5 and D6 at 0.1 % in mixtures from 6 June 2026, entry 78 for synthetic polymer microparticles at 0.01 %, entry 79 for PFHxA and entry 82 for PFAS in firefighting foams. Entry 77 covers formaldehyde emissions from 6 August 2026.

Classification drives the product rules that follow. CLP, Regulation (EC) No 1272/2008, carries the harmonised classifications in Annex VI, and Delegated Regulation (EU) 2023/707 added the hazard classes for endocrine disruption in human health and in the environment, persistent bioaccumulative toxic, very persistent very bioaccumulative, persistent mobile toxic and very persistent very mobile substances, applying to substances from 1 May 2025 and to mixtures from 1 May 2026. The United States counterpart works case by case: the EPA noticed final TSCA risk evaluations for BBP, DBP, DCHP, DEHP and DIBP on 6 January 2026 at 91 FR 373, each finding unreasonable risk to workers, and the section 6(h) persistent bioaccumulative toxic rules already cover decaBDE and phenol, isopropylated phosphate (3:1) with a 0.1 wt% unintentional-presence threshold.

2. Global treaties: the Stockholm Convention and persistent organic pollutants#

Treaty rules eliminate an additive worldwide rather than restricting one use of it, and 7 plastic additives are already listed under the Stockholm Convention: HBCD, decaBDE, SCCP, MCCP, Dechlorane Plus, UV-328 and the PFAS group. HBCD was listed at COP-6 in 2013, decaBDE as SC-8/10 and SCCP as SC-8/11 at COP-8 in 2017, PFOA at COP-9 in 2019, PFHxS at COP-10 in 2022, Dechlorane Plus as SC-11/10 and UV-328 as SC-11/11 at COP-11 in May 2023, and MCCP as SC-12/10 at COP-12, held from 28 April to 9 May 2025. The United States is not a Party to the Convention, so a listing does not by itself change United States law.

The European Union implements the listings through Regulation (EU) 2019/1021. UV-328 is limited to 100 mg/kg from 4 August 2025, 10 mg/kg from 4 August 2027 and 1 mg/kg from 4 August 2029 under Delegated Regulation (EU) 2025/843. Dechlorane Plus is limited to 1,000 mg/kg until 15 April 2028 and to 1 mg/kg after it, under Delegated Regulation (EU) 2025/1930. Polybrominated diphenyl ethers carry a 10 mg/kg limit as a sum, with 350 mg/kg for articles made from recovered material from 30 December 2025 and 200 mg/kg from 30 December 2027, and HBCDD carries 100 mg/kg. For MCCP the delegated regulation C(2026) 6262 was adopted by the Commission on 11 September 2026 and is not yet published in the Official Journal, so no MCCP limit is in force in the European Union today. Each listing, limit and exemption is set out on POPs in plastics.

UV-328 marks the point at which the treaty layer stopped being a flame-retardant story: it is the first non-halogenated plastic additive to become a persistent organic pollutant, and its listing put a light stabilizer used in polyolefin film and PET into the same instrument as HBCD. A wider instrument is still being negotiated. The Global Plastics Treaty session INC-5.2 in Geneva, held from 5 to 15 August 2025, ended without agreement, INC-5.3 met on 7 February 2026 and INC-5.4 is scheduled for 13 to 24 March 2027, and no plastic additive is banned by the treaty.

3. Food contact: positive lists, migration limits and declarations of compliance#

Food-contact rules are positive lists: an additive may be used only if it is named, and only within its specific migration limit, which in the European Union means the Union list of Regulation (EU) No 10/2011 and in the United States 21 CFR parts 174 to 178. Anything not listed is prohibited, which inverts the logic of the chemical-control layer, where anything not restricted is permitted. China GB 9685, the Japanese positive list under the Food Sanitation Act and Mercosur GMC Resolution No. 39/19 follow the same positive-list model.

The Union list, the migration limits and the declaration rules are on EU 10/2011. Its core numbers are a generic specific migration limit of 60 mg/kg food, an overall migration limit of 10 mg/dm2 of contact surface, 60 mg/kg for food intended for infants, and a functional-barrier detection limit of 0.01 mg/kg food. Migration is measured into the 6 Annex III simulants: A, 10 % ethanol; B, 3 % acetic acid; C, 20 % ethanol; D1, 50 % ethanol; D2, vegetable oil; and E, the poly(2,6-diphenyl-p-phenylene oxide) adsorbent known as Tenax.

The plasticizer limits show how sharply a positive list can move. Since Regulation (EU) 2023/1442 the specific migration limits are 0.6 mg/kg food for DEHP, 0.12 mg/kg for DBP and 6 mg/kg for BBP, with DINP and DIDP together at 1.8 mg/kg under group restriction 26 and group restriction 36 set at 0.6 mg/kg expressed as DEHP equivalents. One family is missing from the list entirely: colorants are not on the Union list, so Council of Europe Resolution AP(89)1 and national rules govern them in the European Union, while the United States regulates them through a named CFR section.

4. Product rules: packaging, toys, electronics, medical devices and drinking water#

Product rules apply the same hazard classifications again inside one product type, so an additive that is lawful in a pipe can be prohibited in a toy, a food package, an electronic enclosure or a medical device. They are vertical where the chemical-control layer is horizontal, and they usually express their limits per homogeneous material or per accessible component rather than per article.

Packaging is the largest of them. The heavy-metal sum, the PFAS limits and the recycled-content targets are on the EU Packaging and Packaging Waste Regulation (PPWR) page: Regulation (EU) 2025/40 applies from 12 August 2026, caps lead, cadmium, mercury and hexavalent chromium at 100 mg/kg as a sum, limits PFAS in food-contact packaging to 25 ppb for any targeted PFAS, 250 ppb for the sum of targeted PFAS and 50 ppm total PFAS, and sets minimum post-consumer recycled content from 2030 at 30 % for contact-sensitive PET, 10 % for contact-sensitive non-PET, 30 % for single-use beverage bottles and 35 % for other packaging. RoHS, Directive 2011/65/EU, works to a different denominator: 0.1 % per homogeneous material for lead, mercury, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers, DEHP, BBP, DBP and DIBP, and 0.01 % for cadmium, with the 4 phthalates applying since 22 July 2019 and, for medical devices, in-vitro diagnostics and monitoring instruments, since 22 July 2021.

Three further product regimes reach plastic additives directly. The CPSIA rule at 16 CFR 1307.3 limits 8 ortho-phthalates to 0.1 % in accessible plasticised components of children's toys for children 12 years or younger and child care articles for children 3 years or younger, while 16 CFR 1308 exempts polypropylene, polyethylene, general-purpose, medium-impact, high-impact and super-high-impact polystyrene and ABS with listed additives from third-party testing. The Toy Safety Regulation (EU) 2025/2509 entered into force on 1 January 2026 and applies from 1 August 2030; it prohibits substances with a harmonised carcinogenic, mutagenic or reprotoxic 1A, 1B or 2 classification, an endocrine-disrupting classification, a specific target organ toxicity category 1 classification or a sensitiser classification, prohibits the intentional use of PFAS, and sets migration limits in polymeric toy materials of 0.77 mg/L styrene, 0.01 mg/L acrylonitrile, 0.07 mg/L butadiene, 0.01 mg/L vinyl chloride and 0.005 mg/L bisphenol A. The Medical Device Regulation (EU) 2017/745 requires, in Annex I section 10.4, justification and labelling for carcinogenic, mutagenic or reprotoxic 1A or 1B substances and endocrine disruptors above 0.1 % by weight in invasive or body-fluid-contact devices, and the DEHP authorisation for medical devices carries a latest application date of 1 January 2029 and a sunset date of 1 July 2030 under Regulation (EU) 2023/2482.

5. Waste, recycling and degradability claims#

Waste and degradability rules decide what an additive may claim and where its residues may legally travel, and the sharpest of them is the European ban on products made from oxo-degradable plastic, in force since 3 July 2021. Article 5 of Directive (EU) 2019/904 carries that ban, and Article 3(3) defines oxo-degradable plastic as "plastic materials that include additives which, through oxidation, lead to the fragmentation of the plastic material into micro-fragments or to chemical decomposition". A pro-oxidant masterbatch is therefore prohibited by its mechanism, not by its chemical identity.

Recyclate has its own gatekeeper. Regulation (EU) 2022/1616 on recycled plastic materials and articles intended to come into contact with food entered into force on 10 October 2022 and repealed Regulation (EC) No 282/2008; the suitable recycling technologies it recognises are post-consumer mechanical PET recycling, with a maximum 5 % non-food input and output that may not be used in microwave or conventional ovens, and recycling from closed and controlled product loops. Which recycling technologies are authorised for food contact is covered by recycled plastics regulations.

Two further rules bite on additives that are themselves polymeric or that make a claim. EN 13432 requires at least 90 % biodegradation within 6 months before a compostability claim may be made. REACH Annex XVII entry 78, introduced by Regulation (EU) 2023/2055, restricts synthetic polymer microparticles at 0.01 % by weight, derogates pellets, flakes and powders used at industrial sites, and imposes instructions for use and annual reporting to ECHA by 31 May, first due in 2026 for feedstock users; polymeric powder additives such as polyethylene and polypropylene wax micronisates, PTFE micropowder, PMMA and silicone beads and expandable microspheres fall inside those duties.

Complete List of Plastic Additive Regulations: All 49 Guides#

The complete list of plastic additive regulations below gives all 49 instruments with their layer, jurisdiction, what each one limits and the next date that matters. Rows are ordered by layer, then by jurisdiction, and each regulation name links to its own guide.

Each additive named in the table has its own regulatory matrix in the plastic additives database, with the CAS number, the FCM entry, the CFR section and the restriction entry that apply to it.

Plastic Additive Regulations by Jurisdiction#

An additive sold worldwide meets 5 separate regulatory systems: the European Union, United States federal law, United States state law, the Asia-Pacific and Mercosur positive lists, and Canada, each with its own list, its own limits and its own paperwork. The food-contact layer is the one where the 5 systems are directly comparable, because all of them work as positive lists, and the table below compares them model by model.

European Union#

The European Union regulates a plastic additive on two tracks at once: REACH and CLP control the substance wherever it goes, and Regulation (EU) No 10/2011 controls whether it may touch food. The two tracks are independent. An additive can be fully registered, unrestricted and unclassified and still be unusable in a yoghurt pot because it carries no FCM number, and it can hold an FCM number and still be caught by an Annex XVII entry that applies to all articles.

The restriction track is the one that removes products from the market. Entries 20, 23, 50, 51, 52, 63, 70, 78 and 79 are listed entry by entry under REACH Annex XVII restrictions, and entry 51 alone reaches every flexible PVC article sold in the Union. Alongside it the authorisation track, Annex XIV, removes a use unless the Commission grants it, which is how DOTE reached its sunset date of 1 May 2025, and the Candidate List creates communication duties without removing anything.

The food-contact track has moved 3 times in 2 years. Regulation (EU) 2023/1442 replaced the phthalate specific migration limits. Regulation (EU) 2024/3190, in force since 20 January 2025, prohibits bisphenol A and other hazardous bisphenols in the manufacture of food-contact materials and deletes FCM 151 and FCM 154, with single-use articles placeable on the market until 20 July 2026 and the listed exceptions until 20 January 2028. Regulation (EU) 2025/351 rewrote the rules on purity, on reprocessing off-cuts and scrap, on testing and on good manufacturing practice, and allows products placed on the market before 16 September 2026 to be sold until stocks run out.

Two further European instruments reach additives from outside chemicals law. The POPs Regulation (EU) 2019/1021 sets residue limits that apply to articles and to recyclate rather than to deliberate use, and the PPWR, Regulation (EU) 2025/40, applies packaging-specific limits from 12 August 2026. The universal PFAS restriction under REACH, by contrast, is pending: no restriction text has been adopted, and no compliance date exists for it.

United States: FDA, EPA and CPSC#

Three federal agencies regulate plastic additives in the United States: the FDA for food contact under 21 CFR parts 174 to 181, the EPA for the substance itself under TSCA, and the CPSC for children's products under the CPSIA. There is no single federal additive list, so a compliance statement always names an agency and a citation. Five routes make a food-contact use lawful, and each is listed below.

• A food additive regulation in 21 CFR parts 175 to 178, which names the substance, the polymer and the conditions of use.
• A Food Contact Notification under section 409(h) of the Federal Food, Drug, and Cosmetic Act, effective only for the manufacturer named in it.
• The Threshold of Regulation exemption under 21 CFR 170.39, available at a dietary concentration of 0.5 ppb, about 1.5 micrograms per person per day.
• A prior sanction recorded in 21 CFR part 181, which covers antioxidants in 181.24, plasticizers in 181.27 and stabilizers in 181.29.
• A Generally Recognized As Safe determination for the intended use.

Those 5 routes answer the two questions searchers ask most often about federal food-additive law, because every lawful food-contact additive in the United States sits on one of them, and the FDA regulates the use rather than issuing an approval for the chemical. What is 21 CFR 177? Part 177 lists the permitted resins, the indirect food additives that are polymers, so a polypropylene grade is cleared there. The adjuvants sit in part 178, where the additive limits actually live: 178.2010 for antioxidants and stabilizers, 178.3297 for colorants, 178.3295 for clarifiers, 178.3740 for plasticizers, 178.3130 for antistatic agents, 178.3860 for release agents and 178.3910 for lubricants. Part by part, the CFR sections that carry additive limits are on FDA food contact rules for plastic additives, with worked values such as Irganox 1076 at 0.25 % in olefin polymers, Irgafos 168 at 0.25 % in propylene polymers and 0.2 % in ethylene polymers, and UV-234 at 0.5 % in PET and 3.0 % in polycarbonate.

The other two agencies work on different objects. The EPA noticed final TSCA risk evaluations for BBP, DBP, DCHP, DEHP and DIBP on 6 January 2026 at 91 FR 373, each finding unreasonable risk to workers, which starts a risk-management process rather than a ban. The CPSC enforces 16 CFR 1307.3, the 0.1 % limit on 8 ortho-phthalates in accessible plasticised components of toys and child care articles. The FDA itself has moved twice on plasticizers: the final rule of 20 May 2022 at 87 FR 31080 removed 25 authorisations on abandonment grounds and left exactly 8 ortho-phthalates authorised as food-contact plasticizers, and the scientific evaluation of 27 May 2026 under docket FDA-2026-N-5776, which treats DEHP, DCHP, DIOP and DINP as a cumulative-risk group, is a proposal and not a ban.

United States: California Proposition 65 and the state PFAS laws#

California Proposition 65 does not ban an additive: it requires a warning, and a plastic part triggers one when it exposes a user to a listed additive above the safe-harbour level. The Safe Drinking Water and Toxic Enforcement Act of 1986 carries that duty. The listed plastic additives include DEHP, for cancer since 1 January 1988 and for developmental and male reproductive toxicity since 24 October 2003; DINP for cancer since 20 December 2013, with a no-significant-risk level of 146 micrograms a day; DIDP for developmental toxicity since 20 April 2007; DBP and BBP since 2 December 2005; antimony trioxide for cancer since 1 October 1990; the flame retardants TDCPP since 28 October 2011, TCEP since 1 April 1992 and TBBPA since 27 October 2017; and carbon black and titanium dioxide as airborne, unbound respirable particles. Six common replacements are not listed: DOTP/DEHT, DINCH, ATBC, triphenyl phosphate, DIBP and DCHP.

The full list of additives, their listing dates and their safe-harbour levels is on California Proposition 65 and plastic additives, and it is only the oldest of the state instruments. The fastest-moving layer is now PFAS and flame-retardant legislation in 5 states. Maine's PFAS in Products law, 38 MRSA 1614, bans intentionally added PFAS in its listed product categories from 1 January 2026. Minnesota's Amara's Law bans them in 11 categories from 1 January 2025 and in all products from 1 January 2032 unless a currently unavoidable use is granted. Washington's Safer Products programme restricts organohalogen flame retardants in electronic enclosures and ortho-phthalates in vinyl flooring from 1 January 2025. California AB 2998 has banned covered flame retardants above 1,000 ppm in juvenile products, mattresses and upholstered furniture since 1 January 2020, and New York restricts organohalogen flame retardants in electronic display enclosures.

China, Japan, Korea, India and Mercosur#

Five more positive lists control the same additive in Asia and South America: China's GB 9685, Japan's Food Sanitation Act list, Korea's MFDS standards, India's FSSAI packaging regulations and Mercosur GMC Resolution No. 39/19. None of them recognises a European FCM number or a United States FCN, so each market is a separate filing exercise.

China works through a numbered national standard. GB 9685-2016 took effect on 19 October 2017 and lists about 1,294 permitted additives with specific migration limits, maximum permitted quantities in the material and group limits; Amendment No. 1, XG1-2025, was approved on 16 March 2025 and took effect immediately. The GB 4806 series covers the materials themselves and the GB 31604 series the test methods, and the toy standards GB 6675.1-4:2025 apply to toys manufactured or imported from 1 November 2026, with the numeric limits published in the standard text rather than restated here. The permitted-additive list and its 2025 amendment are covered on China GB 9685 and GB 4806.

Japan, Korea, India and Mercosur each move on their own calendar. Japan's positive list under the Food Sanitation Act has been in force since 1 June 2020 under Notification No. 196 and was revised by Notification No. 324, applying since 1 June 2025, with the voluntary JHOSPA and JHPA industry lists running alongside it; separately, Cabinet Order No. 382 designated UV-328, Dechlorane Plus and methoxychlor as Class I Specified Chemical Substances with effect from 18 February 2025, and an import ban on listed products containing them from 18 June 2025. Korea's MFDS Notification No. 2026-24 of 27 March 2026 requires DEHP migration from PVC food-contact materials to be not detected and sets DEHA at 18 mg/L, with not detected in cling wrap, both applying from 27 March 2027. India's Food Safety and Standards (Packaging) Regulations, 2018 require an overall migration limit of 60 mg/kg or 10 mg/dm2 tested to IS 9845, colorants to IS 9833 and polyethylene constituents to IS 10141. Mercosur GMC Resolution No. 39/19 lists about 1,150 additives with specific migration limits and is implemented in Brazil by ANVISA RDC 326/2019.

Canada#

Canada regulates plastic additives under the Canadian Environmental Protection Act rather than through a food-contact positive list, and its Prohibition of Certain Toxic Substances Regulations, 2025, SOR/2025-270, came into force on 30 June 2026, adding Dechlorane Plus and DBDPE to the prohibited set. Those regulations were registered on 12 December 2025. They tolerate HBCD at 100 mg/kg where its presence is incidental, and polybrominated diphenyl ethers at 1,000 mg/kg in electrical and electronic equipment, 500 mg/kg in other manufactured items and 10 mg/kg in substances.

Toys and child care articles have a separate instrument. The Phthalates Regulations, SOR/2016-188, in force since 22 June 2016, cap DEHP, DBP and BBP at 1,000 mg/kg in the vinyl of toys and child care articles, and DINP, DIDP and DNOP at 1,000 mg/kg in the vinyl of parts that can be placed in the mouth. CEPA, the Phthalates Regulations and SOR/2025-270 are set out on Canadian regulations for plastic additives.

Which Plastic Additives Are Restricted?#

Restrictions concentrate in 5 additive families: low-molecular-weight ortho-phthalate plasticizers, halogenated and phosphorus flame retardants, lead and organotin heat stabilizers, benzotriazole UV absorbers, and a small group of pigments and processing additives. An entry on the SVHC Candidate List is not one of those restrictions. The genuine prohibitions are the Annex XVII entries, the Stockholm listings implemented through Regulation (EU) 2019/1021, and the product-rule limits, and the 14 substances below carry them.

Plasticizers#

Four low-molecular-weight ortho-phthalates are limited to 0.1 % of the plasticised material in every article sold in the European Union: DEHP, DBP, BBP and DIBP, under REACH Annex XVII entry 51, since 7 July 2020. The entry exempts industrial and agricultural articles, outdoor articles without prolonged skin contact, aircraft and motor vehicles placed on the market before 7 January 2024 together with their spare parts, laboratory devices, food contact materials, medical devices, electrical and electronic equipment covered by RoHS, and medicinal product packaging. Prolonged skin contact means more than 10 minutes continuously or more than 30 minutes intermittently per day.

Entry 52 is the entry compounders most often misread. It covers DINP, DIDP and DNOP at 0.1 %, and it applies only to toys and childcare articles that can be placed in the mouth, so DINP is not banned in the European Union and remains a lawful plasticizer for flooring, cable and roofing. In food contact the limits are migration limits rather than content limits: 0.6 mg/kg food for DEHP, 0.12 mg/kg for DBP, 6 mg/kg for BBP and 1.8 mg/kg for DINP and DIDP together, all since Regulation (EU) 2023/1442. Jurisdiction by jurisdiction, the limits are compared on phthalate restrictions worldwide.

The United States position differs on every axis. Exactly 8 ortho-phthalates remain authorised as food-contact plasticizers after the FDA final rule of 20 May 2022, the EPA found unreasonable risk to workers for BBP, DBP, DCHP, DEHP and DIBP on 6 January 2026, and California requires a Proposition 65 warning for DEHP, DINP, DIDP, DBP and BBP above their safe-harbour levels while listing neither DIBP nor DCHP.

Flame retardants#

Three brominated and chlorinated flame retardants are eliminated worldwide as persistent organic pollutants: HBCD since 2013, decaBDE since 2017 and Dechlorane Plus since 2023, each with a residue limit rather than a use permission. A residue limit changes the compliance question from "may I add it" to "how much may remain", which is why these substances continue to appear in recyclate long after the listing date.

Two more brominated products sit one step behind them. TBBPA entered the SVHC Candidate List on 17 January 2023 for its carcinogenicity, and DBDPE followed on 5 November 2025 as very persistent and very bioaccumulative; neither listing restricts use. In the United States the EPA published a draft TSCA risk evaluation for TBBPA on 12 June 2026 finding risk to workers and to the environment, with the comment period closed on 17 August 2026, and it remains a draft. A wider European restriction on aromatic brominated flame retardants is pending: it stands at the call-for-evidence stage, with an Annex XV dossier expected in December 2026 and no adopted text.

Antimony trioxide, the synergist that makes most brominated systems work, carries a harmonised CLP classification as a category 2 carcinogen and a Proposition 65 cancer listing dated 1 October 1990, without a European use restriction. Furniture standards, state bans and the UL requirements sit together on flame retardant regulations.

Heat stabilizers#

Lead stabilizers are prohibited in new PVC articles in the European Union: REACH Annex XVII entry 63 has capped lead at below 0.1 % since 29 November 2024, with a recovered rigid PVC derogation of up to 1.5 % running to 28 May 2033. Regulation (EU) 2023/923 introduced that entry. The parallel derogation for recovered flexible PVC expired on 28 May 2025, and recovered rigid PVC placed on the market under the derogation must be marked "Contains >= 0,1 % lead"; from 28 May 2026 it may be returned only into the same building categories it came from.

Organotins are restricted by content rather than removed. REACH Annex XVII entry 20 limits dibutyltin and dioctyltin compounds to 0.1 % tin by weight in the listed consumer articles, and DOTE sits on Annex XIV as entry 58 with a sunset date of 1 May 2025, after which its use requires an authorisation. The derogation calendar for recovered PVC is set out on lead in PVC.

UV absorbers and antioxidants#

UV-328 is the first non-halogenated plastic additive to become a persistent organic pollutant, listed under the Stockholm Convention in 2023 and limited in the European Union to 100 mg/kg since 4 August 2025. The limit falls to 10 mg/kg on 4 August 2027 and to 1 mg/kg on 4 August 2029 under Delegated Regulation (EU) 2025/843. Three of its benzotriazole siblings reached Annex XIV earlier: UV-320 as entry 54, UV-327 as entry 52 and UV-350 as entry 53, all with a sunset date of 27 November 2023.

Two further benzotriazoles carry Candidate List duties only. Bumetrizole, sold as Tinuvin 326, and UV-329 entered the Candidate List on 23 January 2024 as very persistent and very bioaccumulative substances, and ECHA's draft 13th Annex XIV recommendation of 2 February 2026 proposes UV-326, UV-329 and triphenyl phosphate for authorisation; the recommendation is a draft and the final version is not published, so none of those three is authorisation-listed today. UV-326, UV-328 and UV-329 are tracked one by one on benzotriazole UV absorbers.

Antioxidant restrictions are much narrower than the UV-absorber ones. Antioxidant 2246 entered the Candidate List on 17 January 2022 as a reproductive toxicant, and TNPP entered it on 16 July 2019 where the product contains 0.1 % or more 4-nonylphenol. The two highest-volume stabilizers are unrestricted: Irganox 1010 and Irgafos 168 are not substances of very high concern, both are on the European Union list for food contact, and the FDA concluded its review of Irgafos 168 as safe on 17 June 2023.

Pigments, fillers and processing additives#

Cadmium pigments are capped at below 0.01 % cadmium by weight in the listed plastics under REACH Annex XVII entry 23, and they are the only pigment class the European Union restricts across all of them. That entry has applied since 10 December 2011. No other colorant family carries a horizontal European content limit, which is why the colorant question is usually a food-contact question rather than a restriction question.

Titanium dioxide illustrates how easily a classification is mistaken for a restriction. It has no harmonised European classification after the General Court annulled the previous one on 23 November 2022 and the Court of Justice upheld that annulment on 1 August 2025, yet it appears on the Proposition 65 list as airborne, unbound respirable particles, as does carbon black. In the United States the colorant limits are content limits: 21 CFR 178.3297 permits high-purity furnace black at up to 2.5 wt% with total polycyclic aromatic hydrocarbons at 0.5 ppm and benzo[a]pyrene at 5 ppb, and chromium oxide green at up to 5 wt%.

Processing additives are where the fluorine question lands. Fluoropolymer processing aids are permitted in United States food contact under 21 CFR 177.1520 at 0.2 wt% or less for grades with 65 to 71 % fluorine and 1.0 wt% or less for grades with at least 87 % vinylidene fluoride, and from 12 August 2026 they count toward the PPWR total-PFAS limit in food-contact packaging. The universal European PFAS restriction remains pending, with no adopted text and no compliance date. Where each PFAS rule bites a plastic additive is mapped on PFAS restrictions and plastic additives.

What Changed in 2026, and What Changes Next#

Ten regulatory changes took effect for plastic additives in 2026, and the Packaging and Packaging Waste Regulation, applying from 12 August 2026, is the one that reaches the most compounds. Eleven further dates are already fixed between October 2026 and August 2030, and one more act is adopted but not yet published. The table below lists them in date order, with a status column separating what is in force from what is scheduled and what is still pending publication.

Each change is reported as it is published in plastic additives news, and the dated rows above are updated from the same source.

How Do You Document That an Additive Complies?#

Screen a plastic additive in 6 steps: identify it by CAS number, check the chemical-control layer, check the food-contact list, check the product rules, check the POPs residue limits, then collect the paperwork. The order matters, because a failure at step 2 makes steps 3 to 5 irrelevant. The 6 steps are set out below.

1. Identify the additive by CAS number and EC number, never by trade name, because one trade name can cover more than one chemistry and one chemistry can carry more than one trade name.
2. Check the chemical-control layer in each target market: REACH registration, the Candidate List, Annex XIV and Annex XVII in the European Union, and the TSCA inventory and the section 6(h) rules in the United States.
3. Check the food-contact positive list for each market if the article touches food, and record the FCM number, the CFR section or the FCN number with its conditions of use.
4. Check the product rules for the article type: packaging, toy, electrical equipment, medical device or drinking-water contact.
5. Check the POPs listings and the residue limits that apply to the recyclate the article will be made from or become.
6. Collect the paperwork, then retest on the schedule the regulation sets.

Steps 2 to 4 can be run for one substance at a time in the additive regulatory status checker. A compounder should repeat the whole sequence whenever the grade, the supplier or the application changes, because each of those changes can move the additive into a different conditions-of-use column.

Declarations of compliance, supplier letters and safety data sheets#

Four documents carry a plastic additive's compliance: the EU declaration of compliance, the supplier's food-contact statement, the safety data sheet and the test report behind them. Each has a different issuer and proves a different thing, and none of them substitutes for another. What every field of the declaration of compliance must contain is set out separately.

Two details in that table decide most compliance disputes. A United States supplier letter can state that a grade complies with a named CFR section or is covered by an effective Food Contact Notification, and nothing more, because an FCN binds only the notifier named in it and confers nothing on a second supplier of the same chemical. A safety data sheet is required for a non-classified mixture on request when it contains 0.1 % or more of a Candidate List substance, under REACH Article 31(3), and the CLP label-format obligations of Regulation (EU) 2024/2865 were postponed to 1 January 2028 by Regulation (EU) 2025/2439. Since 16 December 2025 a non-compliant intermediate must say so in its own declaration, under Regulation (EU) 2025/351.

Which tests support a compliance claim#

Each obligation has one test that proves it: migration into the Annex III food simulants for EU food contact, phthalate content for CPSIA and RoHS, total fluorine for the packaging PFAS limits, and UL 94 for the electrical product standards. A document that states a limit without naming the test behind it proves nothing in an enforcement action.

Migration testing under Regulation (EU) No 10/2011 uses the EN 1186 methods for overall migration and EN 13130 for specific migration, with the simulant, the contact time and the contact temperature chosen from Annex III to match the intended use. Simulant choice, contact time and temperature are explained in migration testing of plastics for food contact. Content testing answers a different question: CPSIA at 16 CFR 1307 and RoHS both set a concentration in the material, so the laboratory extracts and quantifies the phthalate rather than measuring what migrates.

Total fluorine screening supports the packaging rules. The PPWR sets 50 mg/kg total fluorine as the trigger above which proof must be given on request that the fluorine present is or is not PFAS, which makes the screening test the gate and the speciation test the defence. For electrical and electronic products the flammability rating is the evidence, and UL 94 is the method that produces it.

Which Regulations Matter for Each Polymer and Application#

Every polymer has one regulatory pressure point set by the additive it cannot do without: PVC by its heat stabilizers and plasticizers, polyolefin film by its fluoropolymer processing aids, PET by its recycled content, and polycarbonate by the bisphenol A ban. The pressure point is rarely the polymer itself, which is why a resin change seldom solves a compliance problem and an additive change usually does.

The full package for each host polymer is on additives by polymer, and the 7 hot spots below are the ones that generate the most compliance work in 2026.

Does a Restriction Mean the Additive Is Harmful?#

A restriction and a hazard are not the same thing: an SVHC Candidate List entry identifies a hazard property and triggers communication duties, while only an Annex XVII entry, a POPs listing or a product-rule limit actually forbids a use. The Candidate List answers the question "what property does this substance have", and the restriction answers "where may it still be used", and the two answers separate more often than the trade press suggests.

Three examples mark the range. DEHP carries a harmonised reproductive-toxicity classification and a restriction that removes it from articles, so hazard and prohibition coincide. Titanium dioxide has no harmonised classification at all after the 2022 annulment, yet a Californian warning duty attaches to its airborne respirable particles, so a duty exists without a European classification. Proposition 65 itself requires a warning and restricts no use whatever, so a listed additive can stay in the product indefinitely. Which additives carry a genuine hazard classification is examined on toxic plastic additives.

How many plastic chemicals are regulated worldwide?#

Only about 6 % of the more than 16,000 chemicals associated with plastics are regulated internationally, according to the PlastChem project led by Martin Wagner at NTNU, whose report was published on 14 March 2024 and peer-reviewed in Nature in 2025. The same project counted more than 4,200 of those chemicals as chemicals of concern.

Three earlier counts frame that figure. UNEP's 2023 report on chemicals in plastics counted more than 13,000 chemicals, of which more than 3,200 have one or more hazardous properties. Wiesinger, Wang and Hellweg at ETH Zürich, writing in Environmental Science and Technology in 2021, counted more than 10,000 substances used in plastics, of which more than 2,400 are of potential concern. ECHA's mapping exercise on plastic additives, by contrast, covers over 400 high-volume additives actually used in the European Union, which is the population this section indexes.

What happens to restricted additives already in products and in recyclate?#

Restricted additives do not leave the material stream when the restriction starts: recovered rigid PVC may still carry up to 1.5 % lead until 28 May 2033, and recovered material may contain polybrominated diphenyl ethers up to 350 mg/kg until 30 December 2027. European law handles that lag with derogations and residue limits rather than with an immediate cut-off.

The derogations are narrow and dated. Recovered rigid PVC under entry 63 must be marked and, since 28 May 2026, may be returned only into the categories it came from. The PBDE limit for articles made from recovered material falls from 350 mg/kg to 200 mg/kg on 30 December 2027, while toys and childcare articles made from recovered material move to 10 mg/kg on 17 May 2027. In the United States the TSCA section 6(h) rules use a 0.1 wt% unintentional-presence threshold with an exclusion for recycled plastic. How much legacy content the measurements find is on legacy additives in recycled plastic.

Measurement confirms the lag rather than contradicting it. In Swiss flooring samples analysed by Wiesinger and colleagues in 2024, 16 % contained regulated chemicals above 0.1 wt%, mainly lead and DEHP, in material that had been placed on the market long before the current limits.

The practical consequence falls on formulation rather than on waste management. An additive package chosen today determines whether the article can re-enter a food-contact or toy stream in 15 years, which is the subject of design for recycling.

How this regulation guide is kept current#

This guide is re-checked against the official texts every January and June, the two months in which the SVHC Candidate List is normally updated, and after every Conference of the Parties to the Stockholm Convention. Between those windows the Official Journal, the Federal Register and the eCFR are checked for European, FDA and EPA actions, and the edition date of the OEHHA list is checked for Proposition 65.

Every value on this page carries the instrument and the date it was checked against, and the verification line at the top of the page carries the date of the last full review: 22 September 2026. Where an act has been adopted but not published, or a restriction is still in opinion, the page says so and prints no compliance date. How corrections are logged and how independence is maintained is stated in the editorial policy.

This is a technical reference, not legal advice. Check the official text before you rely on a value.