12 of the restrictions in REACH Annex XVII apply to substances that are deliberately added to a plastic, and they run from entry 20 (organotins) to entry 79 (PFHxA). Annex XVII is numbered up to entry 83, so which of those entries does a compounder actually have to check? A formulator working with phthalate plasticizers, lead or organotin stabilizers, cadmium pigments, carbon black, siloxane processing aids or polymeric powder additives meets 12 of them, each with its own limit, reference material, exemption set and date of application, and this page indexes all 12 in ascending order.
A restriction under Annex XVII is not the same duty as an authorisation or a Candidate List entry. A restriction applies to every manufacturer, importer and downstream user on the same terms once its conditions are met, unlike an authorisation under REACH Annex XIV, which is granted for a named use to a named applicant, and unlike the SVHC Candidate List, which triggers communication duties rather than a prohibition. Regulation (EC) No 1907/2006 sets Annex XVII as the restriction list, and each entry names its own substances, its own reference material and its own scope of articles.
This page covers what Annex XVII is and how it restricts a compound, the 12 entries from entry 20 to entry 79, a complete compliance table with every exemption and amending act, the restricted substances in the plastic additives database, a 7-step formulation check, how the entries treat recycled plastic, and what changed in 2026. Every group of plastic additives is represented, from plasticizers and stabilizers to pigments and processing aids.
Table T1: The 12 restrictions at a glance
| Entry | Restricted substances | Limit | Applies from |
|---|---|---|---|
| 20 | Dibutyltin (DBT) and dioctyltin (DOT) compounds | 0.1 % Sn by weight | 1 Jan 2012 |
| 23 | Cadmium and its compounds | 0.01 % Cd of the plastic material | 10 Dec 2011 |
| 28-30 | CMR 1A/1B substances in mixtures for the general public | Specific or generic concentration limit | Per appendix |
| 50 | 8 polycyclic aromatic hydrocarbons | 1 mg/kg each, 0.5 mg/kg in toys | 27 Dec 2015 |
| 51 | DEHP, DBP, BBP, DIBP | 0.1 % of the plasticised material | 7 Jul 2020 |
| 52 | DINP, DIDP, DNOP | 0.1 % of the plasticised material, mouthable toys only | 16 Jan 2007 |
| 63 | Lead | 0.1 % Pb of the PVC material | 29 Nov 2024 |
| 68 | C9-C14 PFCAs | 25 ppb sum, 260 ppb related substances | 25 Feb 2023 |
| 70 | D4, D5, D6 | 0.1 % each in mixtures | 6 Jun 2026 |
| 77 | Formaldehyde and releasers | Emission limit set in the entry | 6 Aug 2026 |
| 78 | Synthetic polymer microparticles | 0.01 % by weight | 17 Oct 2023, staged |
| 79 | PFHxA, salts and related substances | 25 ppb / 1,000 ppb | 10 Oct 2026 |
Entries 28 to 30 count as one restriction, so the 12 restrictions cover 14 numbered entries. These are the general values; the exemptions sit in Table T2.
What Is REACH Annex XVII, and How Does It Restrict Plastic Additives?#
REACH Annex XVII is the restriction list of Regulation (EC) No 1907/2006: it names the substances that may not be manufactured, placed on the market or used in the European Union, on their own, in mixtures or in articles, except under the conditions each entry sets. Annex XVII entries are numbered up to entry 83, and each is cited by its number, for example "Annex XVII entry 51," never as "restriction 51" or "REACH 51." A plastic additive is a substance in REACH terms, and it must be registered at 1 tonne a year or more by its manufacturer or importer, including when it arrives inside an imported masterbatch, because a masterbatch is a mixture. Polymers themselves are exempt from registration under Article 2(9).
What does that mean for a compound rather than for a substance? Each entry names its own reference material rather than applying one limit to the whole part: entry 51 measures its 0.1 % against the plasticised material, entry 63 measures lead against the PVC material, and entry 23 measures cadmium against the plastic material. A compound also answers to regulations beyond the restriction list, and Annex XVII is one layer of the plastic additive regulations a compound has to satisfy; food contact and product rules are separate. Never write "banned" as a blanket description of an entry; write "restricted above" its limit instead, because most entries set a concentration limit rather than an outright prohibition.
How Annex XVII differs from the SVHC Candidate List and Annex XIV#
The SVHC Candidate List identifies a hazard and triggers communication duties, Annex XIV forbids a use after its sunset date unless an applicant holds an authorisation, and Annex XVII is the only one of the three that restricts a use outright for every company in the same way. Inclusion in the SVHC Candidate List triggers Article 33 information duties to recipients above 0.1 % weight by weight in an article, an Article 7(2) notification to ECHA above 0.1 % and 1 tonne a year within 6 months, an SCIP database entry since 5 January 2021, and a safety data sheet on request. The Court of Justice confirmed in case C-106/14 of 10 September 2015 that the 0.1 % threshold applies to each component article, not to the assembled product as a whole.
Table T5: The three REACH lists
| List | What inclusion means | What the company must do | Threshold | Where to read more |
|---|---|---|---|---|
| SVHC Candidate List | Hazard identification, not a ban | Article 33 information to recipients, Article 7(2) notification, SCIP entry | 0.1 % w/w of the article | SVHC page |
| Annex XIV (Authorisation List) | Use forbidden after the sunset date unless authorised | Apply for an authorisation for a named use, or substitute | Set per entry | Annex XIV page |
| Annex XVII (Restriction List) | Use restricted or forbidden for everyone | Meet the entry conditions, document them, test where the limit is a trace limit | Set per entry, from 0.01 % to 25 ppb | This page |
Annex XIV, called the Authorisation List, holds 59 entries and forbids use after the sunset date unless an applicant has been granted an authorisation for a named use; DEHP sits on Annex XIV as entry 4, with a latest application date of 1 January 2029 and a sunset date of 1 July 2030 for medical devices under Commission Regulation (EU) 2023/2482. The sunset dates of the REACH Annex XIV Authorisation List decide when an authorised use ends, while an Annex XVII restriction bites the moment its own date of application arrives, with no authorisation route available.
Who must comply with a REACH Annex XVII restriction#
Every actor who manufactures, imports, compounds, converts or sells a plastic in the European Union has to meet the Annex XVII conditions for the substances it contains, because the restrictions attach to the substance, the mixture and the article alike. Four groups carry that duty at different points in the supply chain:
- Additive manufacturer and importer, who registers the substance at 1 tonne a year or more and checks it against every entry before selling it
- Compounder and masterbatch producer, who verifies the dosage of each additive against the reference material the relevant entry sets
- Converter, who confirms that the finished-article classification, toy, food contact material or industrial part, matches the exemptions the compound was formulated under
- Article supplier and distributor, who keeps the compliance documentation and passes it down the chain on request
REACH sets four separate duties that reach a plastic additive at different stages: registration, evaluation, authorisation and restriction. The full duty stack under REACH and plastic additives explains how those four duties interact for a compounder, while entries 28 to 30 add one further duty for whoever supplies a mixture to the general public, since the restriction binds the distributor as much as the producer.
Does Annex XVII apply to the additive, the compound or the finished article?#
It depends on the entry: entry 51 measures its 0.1 % against the plasticised material of the finished article, entry 63 measures lead against the PVC material, entry 78 measures 0.01 % against the substance or mixture placed on the market, and entries 28 to 30 apply only to a mixture supplied to the general public. Entry 23 works the same way as entry 63, against the plastic material of the listed polymers, and entry 79 works against the homogeneous material rather than the finished part as a whole. Never generalise one entry's reference material to another entry; each of the 12 entries sets its own.
Is REACH mandatory in the EU?#
Yes: REACH is Regulation (EC) No 1907/2006 and applies directly in every EU member state, so an Annex XVII restriction bites without any national transposition. No member state can weaken, delay or opt out of a restriction once its date of application arrives. Registration is required at 1 tonne a year or more per manufacturer or importer, and while polymers are exempt under Article 2(9), the additives inside them are not, including when an additive arrives inside an imported masterbatch.
The 12 Annex XVII Entries That Restrict Plastic Additives#
The 12 Annex XVII restrictions that reach a plastic compound are entries 20, 23, 28 to 30, 50, 51, 52, 63, 68, 70, 77, 78 and 79.
Four entries are routinely quoted for plastics and do not apply to a plastic compound: entry 46 and 46a restrict nonylphenol and its ethoxylates to 0.01 % in washable textiles from 3 February 2021 under Commission Regulation (EU) 2016/26, entry 66 restricts bisphenol A in thermal paper to 0.02 % by weight from 2 January 2020, entry 72 restricts CMR substances in textiles and footwear, and entry 82 restricts PFAS in firefighting foams from 23 October 2030 under Commission Regulation (EU) 2025/1988. None of the four constrains a plastic additive as such.
Entry 20: organotin stabilizers and catalysts#
Annex XVII entry 20 limits dibutyltin and dioctyltin compounds to 0.1 % tin by weight in the listed articles supplied to the general public, and has done so since 1 January 2012 under Commission Regulation (EU) No 276/2010. Tri-substituted organotin compounds carry the same 0.1 % tin limit, in force since 1 July 2010 according to testing-house compliance bulletins that track the entry. Dibutyltin (DBT) compounds held three time-limited derogations that ran to 1 January 2015: soft PVC profiles, outdoor PVC-coated fabrics and outdoor rainwater pipes.
Organotin PVC heat stabilizers, among them dioctyltin dilaurate (DOTE) and the butyltin mercaptides, and the tin catalysts used in silane crosslinking, such as dibutyltin dilaurate, are the additive classes entry 20 reaches. DOTE also sits on REACH Annex XIV as entry 58, with a latest application date of 1 November 2023 and a sunset date of 1 May 2025, so a formulator checks both the restriction and the authorisation status of the same substance.
Entry 23: cadmium pigments and cadmium stabilizers in plastics#
Annex XVII entry 23 caps cadmium at below 0.01 % by weight of the plastic material in the listed polymers, from PVC and polyurethane to PP, HDPE and PET, and has applied since 10 December 2011 under Commission Regulation (EU) No 494/2011. The full polymer list covers PVC, polyurethane (PUR), low-density polyethylene (LDPE, except coloured masterbatch), cellulose acetate, cellulose acetate butyrate, epoxy resins, melamine-formaldehyde (MF), urea-formaldehyde (UF), unsaturated polyester (UP), PET, PBT, general-purpose polystyrene (GPPS), acrylonitrile methyl methacrylate (AMMA), crosslinked polyethylene (PE-X) and high-impact polystyrene (HIPS), among others.
Cadmium sulfide and cadmium sulfoselenide reds, oranges and yellows are the only pigment class the European Union restricts across this specific list of polymers, which makes entry 23 the reference point for any colorant formulation still using a cadmium-based pigment. Masterbatch producers should note the LDPE coloured-masterbatch carve-out: cadmium pigments in an LDPE masterbatch intended for colouring are not caught by the entry, while the same pigment in a finished LDPE article is. Recovered rigid PVC is treated separately: it may carry up to 0.1 % cadmium by weight in the listed building uses and must be marked "Contains recovered PVC."
Entries 28 to 30: CMR additives in mixtures sold to the general public#
Annex XVII entries 28 to 30 forbid supplying CMR category 1A and 1B substances to the general public in mixtures at or above their concentration limit, and their appendices name 7 substances used as plastic additives, among them dicumyl peroxide, antioxidant 2246 and zinc pyrithione. Commission Regulation (EU) 2021/2204 added dicumyl peroxide (CAS 80-43-3), 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol, known as antioxidant 2246 (CAS 119-47-1), diisooctyl phthalate (CAS 27554-26-3), dioctyltin dilaurate, dichlorodioctylstannane, zinc pyrithione and tris(2-methoxyethoxy)vinylsilane to Appendix 6. The classification that triggers the entry comes from CLP Annex VI, where dicumyl peroxide carries the hazard class Repr. 1B. The latest appendix update is Commission Regulation (EU) 2025/1731 of 8 August 2025.
These entries do not touch an industrial compound sold between businesses. They bite when an additive or an additive-containing mixture reaches consumers directly, for example a peroxide-cured resin pack or a consumer repair kit sold at or above the substance's specific or generic concentration limit.
Entry 50: the 8 PAHs in rubber and plastic parts#
Annex XVII entry 50 limits each of 8 polycyclic aromatic hydrocarbons to 1 mg/kg in the rubber or plastic parts that touch skin or the mouth, and to 0.5 mg/kg in toys and childcare articles, for articles first placed on the market from 27 December 2015, under Commission Regulation (EU) No 1272/2013. The limit applies to rubber or plastic components that come into direct and prolonged skin or oral contact, or into short-term repetitive contact.
Entry 50 is a purity requirement on the pigment, not a dosage limit on the compound: a grip, a cable jacket or a handle fails the entry on the grade of carbon black it uses, not on how much of it the formulation contains. Carbon black and extender oils are the two additive classes that carry PAHs into a compound. The United States sets a comparable purity route for carbon black in 21 CFR 178.3297, which allows high-purity furnace black up to 2.5 wt% of the polymer, with total PAH content at or below 0.5 ppm and benzo[a]pyrene at or below 5 ppb.
Entry 51: DEHP, DBP, BBP and DIBP in every article#
Annex XVII entry 51 limits DEHP, DBP, BBP and DIBP to 0.1 % by weight of the plasticised material, individually or combined, in every article placed on the EU market since 7 July 2020, under Commission Regulation (EU) 2018/2005. The 4 substances are DEHP (CAS 117-81-7), DBP (CAS 84-74-2), BBP (CAS 85-68-7) and DIBP (CAS 84-69-5); toys and childcare articles met an earlier deadline before the entry extended to every article category.
Exemptions cover industrial or agricultural articles and open-air-only articles without mucous-membrane or prolonged skin contact, aircraft and motor vehicles placed on the market before 7 January 2024 and their repair parts, laboratory measuring devices, food contact materials under Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011, medical devices, electrical and electronic equipment under RoHS, and the immediate packaging of medicinal products.
Entry 51 is the single entry that changed European plasticizer selection: it removed the 4 low-molecular-weight ortho-phthalates from general article production. The food-contact and medical-device exemptions exist because those articles already answer to their own instruments, not because the four substances are considered safe there. Entry 51 never bans phthalates as a class; it names exactly 4 substances, and non-phthalate alternatives such as DOTP, DINCH, ATBC, TOTM and DPHP fall outside the entry entirely.
What counts as plasticised material, and what is prolonged skin contact?#
Plasticised material in entry 51 is not limited to PVC: it covers PVDC, PVA, polyurethanes and any other polymer, including foams and rubber, with silicone rubber and natural latex coatings excluded, and it reaches the printed designs, decals, adhesives and coatings on the article as well. The definition also extends to surface coatings, non-slip coatings, finishes, sealants, paints and inks applied to an article, so a rigid part carrying a printed decal or a painted finish falls inside the entry even when the base polymer itself carries no plasticizer.
Prolonged skin contact, the second term the entry defines, means continuous contact of more than 10 minutes, or intermittent contact that adds up to more than 30 minutes a day. An article that meets neither threshold, and is not placed in the mouth, can fall under the industrial or open-air exemption instead.
Is DEHP still allowed in medical devices?#
Yes, for now: entry 51 exempts medical devices, so DEHP in a device is governed by the authorisation route instead, where the latest application date is 1 January 2029 and the sunset date 1 July 2030 under Commission Regulation (EU) 2023/2482. DEHP sits on REACH Annex XIV as entry 4, and a device manufacturer holding no authorisation after the sunset date must reformulate or seek a new one. Medical Device Regulation Annex I, section 10.4, separately requires justification above 0.1 % weight by weight in invasive or fluid-contact devices and labelling of the device, so a device already meets a second layer of scrutiny independent of the Annex XIV sunset date. A device placed on the market before the sunset date is not automatically withdrawn.
Which plasticizers replace DEHP, DBP, BBP and DIBP?#
The five non-phthalate plasticizers used in Europe are DOTP, DINCH, ATBC, TOTM and DPHP, none of which is on the SVHC Candidate List or restricted by Annex XVII. DOTP, also known as DEHT, is a terephthalate, not an ortho-phthalate, so entry 51 does not reach it at all. Grades, dosage and migration behaviour of the non-phthalate plasticizers are compared family by family, from the general-purpose profile of DINCH to the high-temperature performance of TOTM. DPHP and ATBC round out the group, each suited to a narrower set of applications than DOTP or DINCH.
Entry 52: DINP, DIDP and DNOP in mouthable toys and childcare articles#
Annex XVII entry 52 prohibits DINP, DIDP and DNOP above 0.1 % by weight of the plasticised material in toys and childcare articles that a child can put in the mouth, and nowhere else. The three substances are DINP (CAS 28553-12-0 and 68515-48-0), DIDP (CAS 26761-40-0 and 68515-49-1) and DNOP (CAS 117-84-0); the restriction dates from 16 January 2007 and is consolidated by Regulation (EC) No 552/2009.
This is the most misquoted entry in the cluster. DINP is not banned in the EU: it is restricted in mouthable toys and childcare articles only, and it remains authorised in food contact applications within the group specific migration limit set for DINP and DIDP together under Regulation (EU) No 10/2011. Outside mouthable toys and childcare articles, a compounder can use DINP, DIDP or DNOP without triggering entry 52 at all.
Entry 63: lead stabilizers in PVC#
Annex XVII entry 63 prohibits lead at or above 0.1 % by weight of the PVC material in PVC articles from 29 November 2024, under Commission Regulation (EU) 2023/923. PVC articles already placed on the market before 28 November 2024 are exempt from the entry, so existing stock does not need to be withdrawn.
The entry does not apply to articles covered by Regulation (EC) No 1935/2004 for food contact, Directive 2011/65/EU (RoHS) for electrical and electronic equipment, Directive 94/62/EC for packaging or Directive 2009/48/EC for toys, and PVC-silica separators in lead-acid batteries carry their own exemption until 28 May 2033.
Entry 63 ends the use of lead stabilizers in new European PVC: tribasic lead sulfate, tetrabasic lead sulfate, dibasic lead phosphite and the lead stearates all fall inside the 0.1 % limit. Calcium-zinc stabilizer systems and, in some applications, organotin stabilizers are the two replacement routes European compounders use in place of lead, with the choice depending on the processing temperature and the end application; the heat-stabilizer selection itself belongs to a dedicated formulation guide.
Which recycled PVC may still contain lead?#
Only recovered rigid PVC: it may contain up to 1.5 % lead until 28 May 2033, in the listed building uses, and each article carries the marking "Contains >= 0,1 % lead." Four conditions define the derogation:
- Stay below 1.5 % lead by weight of the PVC material until 28 May 2033
- Use the recyclate only in the listed building applications: exterior profiles and sheets excluding decks, the covered middle layer of decks, concealed spaces, interior profiles with a surface layer below 0.1 % lead, the middle layer of multilayer non-drinking-water pipes and non-drinking-water fittings
- Mark every qualifying article "Contains >= 0,1 % lead"
- Route material from these categories back into the same categories only, from 28 May 2026 (the closed-loop channelling rule)
The recovered flexible PVC derogation offers no such route: it expired on 28 May 2025, with no concentration cap set in the Official Journal text for the period it ran, and the Commission reviews the rigid-PVC derogation as a whole by 28 May 2028.
Entry 68: C9 to C14 perfluorocarboxylic acids#
Annex XVII entry 68 limits C9 to C14 perfluorocarboxylic acids to 25 ppb as a sum, and their related substances to 260 ppb, in substances, mixtures and articles placed on the EU market since 25 February 2023, under Commission Regulation (EU) 2021/1297. The limit is a residue limit, not an additive dosage limit: it constrains fluoropolymer processing aids and PTFE-based additives through the trace fluorochemicals they can carry rather than through any deliberate use of C9-C14 PFCAs as an additive. A compounder buying fluoropolymer processing aids or PTFE micropowder checks the supplier's residue data against both figures, the 25 ppb sum and the 260 ppb related-substance figure, since either one can be exceeded independently.
Entry 70: D4, D5 and D6 siloxanes#
Annex XVII entry 70 prohibits D4, D5 and D6 at or above 0.1 % by weight each in substances and mixtures from 6 June 2026, under Commission Regulation (EU) 2024/1328. The three substances are octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6); leave-on cosmetics follow from 6 June 2027, and medical devices and medicinal products from 6 June 2031, with industrial derogations that include the production of articles.
The additives exposed are silicone-based: silicone mould release agents and external lubricants, silicone anti-scratch and slip masterbatches, and silicone processing aids, where D4, D5 and D6 are residual cyclics carried over from the silicone polymer rather than deliberate ingredients in the formulation.
Entry 77: formaldehyde and formaldehyde releasers in articles#
Annex XVII entry 77 limits the formaldehyde that an article may release into the air, under Commission Regulation (EU) 2023/1464, from 6 August 2026, and from 6 August 2027 for road vehicles. The emission limit itself is set out in the entry text rather than restated here, because the values vary by article category. Entry 77 is relevant to polymers and compounds that release formaldehyde in service, and to any plastic part inside a road vehicle, where the later 2027 date applies instead of the general 2026 date. A compounder working with formaldehyde-releasing stabilizer or crosslinking chemistry checks the entry text directly for the figure that applies to its article category.
Entry 78: synthetic polymer microparticles#
Annex XVII entry 78 prohibits synthetic polymer microparticles at 0.01 % by weight or more in substances and mixtures where they are there to confer a sought-after characteristic, and it has been staged in since 17 October 2023 under Commission Regulation (EU) 2023/2055. A synthetic polymer microparticle is a solid polymer that makes up 1 % or more by weight of a particle, or forms a continuous surface coating on it, where 1 % or more of the particles have all dimensions of 5 mm or less, or a length of 15 mm or less with a length-to-diameter ratio above 3. Natural polymers that are not chemically modified, polymers proven degradable under Appendix 15, polymers with a solubility above 2 g/L under Appendix 16, and polymers without carbon are excluded from the definition.
Entry 78 is the entry that reaches the additive supplier itself rather than the finished article, because pellets, flakes and powders are synthetic polymer microparticles by definition and stay on the market only through the industrial-site derogation under paragraph 4(a). From 17 October 2025, suppliers using that derogation must give instructions for use and disposal, the entry 78 statement, the quantity or concentration and the generic polymer identity, and annual reporting to ECHA is due by 31 May, starting in 2026 for manufacturers and industrial downstream users of pellets, flakes and powders used as feedstock, and in 2027 for the others.
Which powder additives count as synthetic polymer microparticles?#
Six additive product forms meet the entry 78 definition:
- Micronised polyethylene and polypropylene waxes
- PTFE micropowder
- PMMA beads used as antiblock and matting agents
- Silicone beads used as antiblock and matting agents
- Expandable microspheres
- Polymeric impact-modifier powders
Each of these products is a synthetic polymer microparticle in its own right, not only when it disperses into microparticles during processing, so the entry 78 duties attach at the point of supply. Feedstock pellets, flakes and powders carry the same status but rely on the industrial-site derogation, while other sectors that use these forms in consumer-facing applications follow staged transitional dates that run from 17 October 2027 for rinse-off cosmetics to 17 October 2035 for lip, nail and make-up products.
Entry 79: PFHxA, its salts and related substances#
Annex XVII entry 79 limits PFHxA and its salts to 25 ppb, and PFHxA-related substances to 1,000 ppb, in the homogeneous material, with the first consumer deadlines falling on 10 October 2026 under Commission Regulation (EU) 2024/2462. The staged dates run from 10 April 2026 for firefighting foams used in training and testing and by public fire services, to 10 October 2026 for consumer clothing textiles, footwear, paper and board food contact materials, consumer mixtures and cosmetics, 10 October 2027 for other consumer textiles, and 10 October 2029 for civil aviation foams.
Like entry 68, entry 79 is a residue limit that constrains fluorochemical impurities in fluoropolymer processing aids and coatings rather than a limit on a plastic additive used deliberately for its own function.
Complete List of Annex XVII Restrictions for Plastic Compounds#
The complete list below gives all 12 Annex XVII restrictions that apply to plastic compounds, with the articles each one covers, its main exemptions, the additive families it hits and the act that introduced it. Table T2 repeats only the entry number from the table above; every other column carries information not given elsewhere on the page, so no value appears twice.
Table T2: Master compliance table
| Entry | Which articles it covers | Key exemptions and derogations | Additive families affected | Amending act | Where to read more |
|---|---|---|---|---|---|
| 20 | Listed consumer articles (soft PVC profiles, coated fabrics, rainwater pipes and others) | Time-limited DBT derogations closed 1 Jan 2015 | Organotin heat stabilizers, silane crosslinking catalysts | Reg. (EU) No 276/2010 | organotin restrictions |
| 23 | PVC, PUR, LDPE and other listed polymers | LDPE coloured masterbatch; recovered rigid PVC up to 0.1 % Cd | Cadmium pigments | Reg. (EU) No 494/2011 | This page |
| 28-30 | Mixtures supplied to the general public | Industrial or professional-only supply falls outside the entries | Peroxides, antioxidants, biocidal additives, one phthalate, organotin catalysts | Reg. (EU) 2021/2204; appendices updated by Reg. (EU) 2025/1731 | CLP classification of plastic additives |
| 50 | Rubber and plastic parts with skin or oral contact, and toys | None general | Carbon black, extender oils | Reg. (EU) No 1272/2013 | This page |
| 51 | Every article, from 7 Jul 2020 | Industrial/agricultural, pre-2024 vehicles and aircraft, laboratory devices, FCM, medical devices, RoHS EEE, medicinal packaging | Ortho-phthalate plasticizers | Reg. (EU) 2018/2005 | phthalate restrictions worldwide |
| 52 | Mouthable toys and childcare articles | All other article types fall outside the entry | Ortho-phthalate plasticizers (DINP, DIDP, DNOP) | Reg. (EC) No 552/2009 | additives in toys and childcare articles |
| 63 | PVC articles, from 29 Nov 2024 | FCM, RoHS EEE, packaging, toys; recovered rigid PVC to 1.5 % until 2033; battery separators to 2033 | Lead heat stabilizers | Reg. (EU) 2023/923 | lead in PVC |
| 68 | Substances, mixtures and articles | None stated | Fluoropolymer processing aids | Reg. (EU) 2021/1297 | PFAS restrictions and plastic additives |
| 70 | Substances and mixtures, from 6 Jun 2026 | Industrial derogations incl. article production; later dates for cosmetics and medical devices | Silicone mould release agents, slip and antiblock masterbatches | Reg. (EU) 2024/1328 | This page |
| 77 | Articles that emit formaldehyde, from 6 Aug 2026, vehicles 2027 | None stated | Formaldehyde-releasing stabilizers, crosslinkers | Reg. (EU) 2023/1464 | This page |
| 78 | Substances and mixtures placed on the market, staged from 17 Oct 2023 | Industrial-site derogation (4(a)); feedstock pellets, flakes and powders | Polymeric processing powders, antiblock and matting agents | Reg. (EU) 2023/2055 | EU microplastics restriction |
| 79 | Homogeneous material in listed consumer and industrial uses, staged from 10 Apr 2026 | Staged by sector through 2029 | Fluoropolymer processing aids and coatings | Reg. (EU) 2024/2462 | See entry 68 above |
Seven of the 12 entries have a dedicated regulation page on this site, linked from the last column, while entries 23, 50, 70, 77 and 79 are covered here in full because no deeper page yet exists for them.
Which Plastic Additives Are Restricted Under Annex XVII?#
23 of the substances in our substance directory are touched by an Annex XVII entry, and they fall into 4 groups: ortho-phthalate plasticizers, lead and organotin heat stabilizers, cadmium pigments and carbon black, and the polymeric powders and silicones used as processing additives. The plasticizer group carries the most rows, with DEHP, DBP, BBP and DIBP under entry 51 and DINP, DIDP and DNOP under entry 52. The stabilizer group covers 4 lead compounds under entry 63 and 3 organotin compounds under entry 20, one of which, dibutyltin dilaurate, also appears in Appendix 6 of entries 28 to 30. Cadmium pigments and carbon black each carry a single-entry restriction, under entry 23 and entry 50.
Table T3: Restricted additives, substance-level view
| Additive | Additive family | Annex XVII entry | Limit that applies | Status | Substance page |
|---|---|---|---|---|---|
| DEHP | plasticizers | 51 | 0.1 % of the plasticised material | Restricted | DEHP |
| DBP | Plasticizers | 51 | 0.1 % of the plasticised material | Restricted | DBP |
| BBP | Plasticizers | 51 | 0.1 % of the plasticised material | Restricted | BBP |
| DIBP | Plasticizers | 51 | 0.1 % of the plasticised material | Restricted | DIBP |
| DINP | Plasticizers | 52 | 0.1 % of the plasticised material, mouthable toys only | Restricted in listed articles only | DINP |
| DIDP | Plasticizers | 52 | 0.1 % of the plasticised material, mouthable toys only | Restricted in listed articles only | DIDP |
| DNOP | Plasticizers | 52 | 0.1 % of the plasticised material, mouthable toys only | Restricted in listed articles only | DNOP |
| Tribasic lead sulfate | PVC heat stabilizers | 63 | 0.1 % Pb of the PVC material | Restricted | tribasic lead sulfate |
| Tetrabasic lead sulfate | PVC heat stabilizers | 63 | 0.1 % Pb of the PVC material | Restricted | tetrabasic lead sulfate |
| Dibasic lead phosphite | PVC heat stabilizers | 63 | 0.1 % Pb of the PVC material | Restricted | dibasic lead phosphite |
| Lead stearate | PVC heat stabilizers | 63 | 0.1 % Pb of the PVC material | Restricted | lead stearate |
| DOTE | PVC heat stabilizers | 20 | 0.1 % Sn by weight | Restricted in listed articles only | DOTE |
| Butyltin mercaptide | PVC heat stabilizers | 20 | 0.1 % Sn by weight | Restricted in listed articles only | butyltin mercaptide |
| Dibutyltin dilaurate | PVC heat stabilizers | 20 (also Appendix 6 of entries 28-30) | 0.1 % Sn by weight | Restricted in listed articles only | dibutyltin dilaurate |
| Cadmium pigments | colorants for plastics | 23 | 0.01 % Cd of the plastic material | Restricted in listed articles only | cadmium pigments |
| Carbon black | Colorants for plastics | 50 | 1 mg/kg PAH sum, 0.5 mg/kg in toys | Restricted in listed articles only | carbon black |
| Dicumyl peroxide | crosslinking agents | 28-30 | Supply to general public forbidden at or above the CLP limit | Restricted in listed articles only | dicumyl peroxide |
| Antioxidant 2246 | antioxidants for plastics | 28-30 | Supply to general public forbidden at or above the CLP limit | Restricted in listed articles only | antioxidant 2246 |
| Zinc pyrithione | antimicrobial additives | 28-30 | Supply to general public forbidden at or above the CLP limit | Restricted in listed articles only | zinc pyrithione |
| PTFE micropowder | polymer processing aids | 78 (residue context: entry 68) | 0.01 % by weight | Restricted | PTFE |
| Polyethylene wax | processing lubricants | 78 | 0.01 % by weight | Restricted | polyethylene wax |
| Polydimethylsiloxane | mold release agents | 70 (source of D4, D5, D6 residues) | 0.1 % each of D4, D5, D6 | Restricted in listed articles only | polydimethylsiloxane |
| TNPP | Antioxidants for plastics | Not restricted by Annex XVII | Not applicable | Not restricted by Annex XVII | TNPP |
TNPP carries no Annex XVII restriction at all, and its entry in the plastic additives database records that status directly, since entry 46 is sometimes quoted for it in error. Every substance in the table has its own regulatory matrix in the plastic additives database.
How Do You Check a Plastic Formulation Against Annex XVII? 7 Steps#
Check a formulation in 7 steps: list every substance, match against the 12 entries, classify the article, apply each limit to its own reference material, treat recyclate separately, collect the evidence, and set a re-check date.
- List every substance in the compound by CAS number and EC number, including impurities and residues above 0.1 %.
- Match each CAS number against the 12 entries in the table above, then against the Candidate List and Annex XIV.
- Classify the article: toy, childcare article, consumer article with prolonged skin contact, food contact material, electrical equipment, medical device or vehicle part, because the entry 51 and entry 63 exemptions turn on that classification.
- Take each limit against its own reference material, not against the whole part.
- Treat any recycled fraction separately, because the derogations for recovered PVC carry their own limits, markings and end dates.
- Collect the evidence: a supplier declaration that names the entry number, the safety data sheet, the entry 78 supplier information where powders are involved, and an analytical result wherever the limit is a trace limit in ppb.
- Set a re-check date for January and June and for every dated amendment in the change table below.
Download the Annex XVII compliance checklist for plastic compounds (PDF): the 12 entries, the reference material for each limit, and the evidence to file, in one document.
Check one additive against every list at once with the additive regulatory status checker.
This page provides technical information for formulators and compounders, not legal advice, and a borderline classification should go to qualified regulatory counsel before a compound ships.
Which Annex XVII Entries Apply to Recycled Plastics?#
Three Annex XVII entries treat recycled plastic differently from virgin plastic: entry 63 allows recovered rigid PVC to carry up to 1.5 % lead until 28 May 2033, entry 23 allows the same material up to 0.1 % cadmium in listed building uses, and entry 78 keeps recyclate flakes and powders on the market through its industrial-site derogation. Restabilization and decontamination of recyclate are covered in additives for recycled plastics, the formulation guide this page links into for the additive side of the same material.
Entry 63 sets the most detailed recyclate route: recovered rigid PVC below 1.5 % lead by weight of the PVC material until 28 May 2033, marked "Contains >= 0,1 % lead," with closed-loop channelling of the same categories from 28 May 2026 and a Commission review of the whole derogation by 28 May 2028. The recovered flexible PVC derogation carried no such extension and ended on 28 May 2025.
Entry 23 grants a narrower allowance: recovered rigid PVC may carry up to 0.1 % cadmium in the listed building uses, marked "Contains recovered PVC," never as permission to add fresh cadmium pigment to a new formulation. The derogation and its marking duty are worked through on recycled PVC, where restabilization after decontamination gets its own treatment.
Legacy content is measurable in circulation today: in Swiss flooring samples analysed by Wiesinger and colleagues in 2024, 16 % contained regulated chemicals above 0.1 % by weight, mainly lead and DEHP, evidence that a recyclate stream needs its own Annex XVII check rather than an assumption of compliance carried over from virgin material.
What Changed in Annex XVII in 2026, and Which Restrictions Are Coming Next#
Five Annex XVII dates fell in 2026: the closed-loop rule for recovered rigid PVC on 28 May, the first entry 78 report to ECHA on 31 May, the siloxane restriction of entry 70 on 6 June, the formaldehyde emission limits of entry 77 on 6 August, and the first PFHxA deadlines of entry 79 on 10 October. In 2025, two dates applied: the recovered flexible PVC derogation of entry 63 ended on 28 May 2025, and Commission Regulation (EU) 2025/1731 of 8 August 2025 updated the Appendix 6 substance list of entries 28 to 30.
Four items remain pending for plastics. The universal PFAS restriction carries a RAC final opinion of 2 March 2026 and a SEAC draft opinion of 10 March 2026, with the final opinion expected at the end of 2026; write it as pending, never as an existing ban. A restriction on aromatic brominated flame retardants had a call for evidence that ran from 21 January to 18 March 2026, with an Annex XV dossier expected in December 2026. ECHA's investigation of PVC and its additives, opened in November 2023, named lead, ortho-phthalates, organotins, chlorinated paraffins and brominated and chlorinated flame retardants, and the Commission follow-up is still open. ECHA's screening of UV-320, UV-327 and UV-350 in articles, from January 2024, has an unconfirmed dossier status.
Table T4: Annex XVII change log for plastic additives
| Date | Entry or instrument | What applies | Status |
|---|---|---|---|
| 28 May 2025 | Entry 63 | Recovered flexible PVC derogation ends | Applied |
| 8 Aug 2025 | Reg. (EU) 2025/1731 | Appendix 6 update to entries 28-30 | Applied |
| 17 Oct 2025 | Entry 78 | Supplier information duties begin | Applied |
| 28 May 2026 | Entry 63 | Closed-loop channelling of recovered rigid PVC | Applied |
| 31 May 2026 | Entry 78 | First annual report to ECHA due | Applied |
| 6 Jun 2026 | Entry 70 | D4, D5, D6 restriction in force | Applied |
| 6 Aug 2026 | Entry 77 | Formaldehyde emission limits in force | Applied |
| 10 Oct 2026 | Entry 79 | PFHxA consumer-use deadlines | Applied |
| 6 Aug 2027 | Entry 77 | Road vehicles deadline | Scheduled |
| 10 Oct 2027 | Entry 79 | Other consumer textiles deadline | Scheduled |
| 28 May 2028 | Entry 63 | Commission review of the derogation | Scheduled |
| 10 Oct 2029 | Entry 79 | Civil aviation foams deadline | Scheduled |
| 17 Oct 2029 / 17 Oct 2031 | Entry 78 | Staged sector bans | Scheduled |
| 28 May 2033 | Entry 63 | Recovered rigid PVC derogation and battery-separator exemption end | Scheduled |
| Pending | Universal PFAS restriction | RAC and SEAC opinions in progress, final expected end 2026 | Pending |
| Pending | Aromatic brominated flame retardant restriction | Call for evidence closed, Annex XV dossier expected Dec 2026 | Pending |
| Pending | UV-320, UV-327, UV-350 in articles | ECHA screening complete, dossier status unconfirmed | Pending |
| Pending | POPs listings affecting plastic additives (MCCP, Stockholm Annex A, COP-12 2025) | EU delegated regulation adopted, not yet in force; tracked separately on POPs in plastics | Pending |
Does an Annex XVII Entry Mean the Additive Is Banned?#
Only in part: most Annex XVII entries set a concentration limit for a named material and a named type of article, so the same additive can be lawful in an industrial pipe and unlawful in a toy, and DINP under entry 52 is the clearest example. A Candidate List entry is not a ban at all, since it triggers only the communication duties described above. Hazard classification alone restricts nothing either: the classification that drives entries 28 to 30 comes from CLP, and titanium dioxide shows how far that principle reaches, since the General Court annulled its classification on 23 November 2022 and the Court of Justice upheld that annulment on 1 August 2025.
A reader who lands here searching for toxic plastic additives is usually asking a broader question than Annex XVII answers, because hazard, exposure and restriction are three separate questions, and an entry can settle the third while the first two remain open for a separate page to cover in full.
What are the recent updates to REACH Annex XVII?#
The most recent additions to Annex XVII are entry 83 for 2,4-dinitrotoluene under Regulation (EU) 2026/859 and entry 82 for PFAS in firefighting foams under Regulation (EU) 2025/1988, neither of which restricts a plastic additive. Working backward through the dates that do reach plastics: the appendices of entries 28 to 30 were last updated by Commission Regulation (EU) 2025/1731 of 8 August 2025, adding dicumyl peroxide, antioxidant 2246, zinc pyrithione and 4 further substances relevant to plastics. Entry 70, the D4, D5 and D6 siloxane restriction, was introduced by Regulation (EU) 2024/1328, and entry 79, the PFHxA restriction, by Regulation (EU) 2024/2462, both now in force. Each update carries its own date of application rather than a single "update date" for the annex as a whole, so a compounder tracks the date attached to the specific entry it uses.
Is there going to be a REACH revision in 2026?#
No: the Commission set the full REACH revision aside on 27 April 2026, so the changes that reach plastic additives in 2026 and 2027 come through amendments of the annexes, Annex XVII among them, rather than through a new regulation. The revision, as originally proposed, would have added polymer registration, a duty that does not currently exist for polymers under Article 2(9). Simplification of REACH continues instead through comitology, meaning each annex amendment goes through its own committee procedure and its own Official Journal publication, which is why this page tracks dated amendments entry by entry rather than a single revision timeline. The universal PFAS restriction remains the largest pending item for plastics regardless of the revision's fate.
Which countries outside the EU restrict the same plastic additives?#
Four jurisdictions restrict the same additives by different routes: the United States through CPSIA and TSCA, California through Proposition 65 warnings, Canada through its Phthalates Regulations, and China through the GB toy standards. In the United States, the CPSIA phthalate limits cap 8 phthalates, including DEHP, DBP, BBP and DINP, at 0.1 % in children's toys and childcare articles under 16 CFR 1307, a final rule dated 27 October 2017 that took effect 25 April 2018. Separately, the TSCA and plastic additives risk-evaluation process produced final risk evaluations for BBP, DBP, DCHP, DEHP and DIBP, published 6 January 2026 in 91 FR 373.
California lists DEHP under California Proposition 65 for cancer since 1 January 1988 and DINP since 20 December 2013, with a no-significant-risk level of 146 micrograms a day. Canada limits DEHP, DBP and BBP to 1,000 mg/kg in the vinyl of toys and childcare articles under SOR/2016-188, one layer of the Canadian regulations for plastic additives that expands on 30 June 2026 when the Prohibition of Certain Toxic Substances Regulations, 2025 (SOR/2025-270) enters into force. China applies GB 6675.1-4:2025 to toys made or imported from 1 November 2026, with older compliant stock saleable until 31 October 2027.
Table T6: The same additives outside the EU
| Jurisdiction | Instrument | What it does to the same additives | Date | Where to read more |
|---|---|---|---|---|
| United States | CPSIA 16 CFR 1307 | Caps 8 phthalates, including DEHP, DBP, BBP and DINP, at 0.1 % in children's toys and childcare articles | Final rule 27 Oct 2017, effective 25 Apr 2018 | CPSIA phthalate limits |
| United States | TSCA | Final risk evaluations for BBP, DBP, DCHP, DEHP and DIBP | Published 6 Jan 2026 (91 FR 373) | TSCA and plastic additives |
| California | Proposition 65 | Cancer warning requirement covering DEHP and DINP | DEHP listed 1 Jan 1988; DINP listed 20 Dec 2013 | California Proposition 65 |
| Canada | SOR/2016-188; SOR/2025-270 | Limits DEHP, DBP and BBP to 1,000 mg/kg in the vinyl of toys and childcare articles | SOR/2016-188 in force 22 Jun 2016; SOR/2025-270 in force 30 Jun 2026 | Canadian regulations for plastic additives |
How this page is updated: regulatory watch and news#
This page carries the date on which each entry was last checked against the Official Journal text, and it is reviewed every January and June, when the Candidate List is updated, and whenever an amending regulation is published. Five testing houses publish the bulletins this page's editorial team tracks between reviews: SGS, Intertek, TUV SUD, Eurofins and Bureau Veritas, each of which issues dated compliance alerts when an Annex XVII amendment reaches the Official Journal. Coverage of every dated change, alongside SVHC and POPs updates, also runs on plastic additives news, the site's regulatory news hub.