REACH, Regulation (EC) No 1907/2006, reaches a plastic through its additives rather than through the polymer, and it does so in 4 steps: registration, evaluation, authorisation and restriction. Polymers are exempt from registration under Article 2(9), so every REACH duty in a compounding plant attaches to something that weighs a few per cent of the formulation. Which step bites first?
The four steps run in a fixed order, and each one raises the stakes for the formulator. Registration decides whether the additive may be sold in the European Union at all, at 1 tonne a year or more per manufacturer or importer. Evaluation decides whether the authorities look closer, either at the registration dossier or at the substance itself. Authorisation can close a named use after a fixed sunset date once a substance is identified as a substance of very high concern. Restriction sets a hard concentration limit in a defined article or use, with no application procedure to escape it.
This page sets out what REACH is and how its four processes apply to a plastic additive, which additives REACH already names by entry number and date, the duties that start automatically once an additive enters the SVHC Candidate List, what ECHA's own registration data show about the additives already in use above 100 tonnes a year, how REACH sits alongside RoHS, CLP and the food-contact rules, the REACH dates that fall on plastics in 2026 and 2027, and a 6-step method for checking the status of one additive. REACH status verified: 22 September 2026. This reference is technical, not legal advice.
| Step | What it does to an additive | Trigger | Worst case for the formulator | Where the detail is |
|---|---|---|---|---|
| 1. Registration | Puts the additive and its uses in an ECHA dossier | Manufacture or import of 1 tonne a year or more per actor | The additive is not registered for your use and cannot be bought in the EU | This page |
| 2. Evaluation | Checks the dossier, or examines the substance under a member state plan | ECHA or a member state selects it | A request for more data, or a move towards authorisation or restriction | This page |
| 3. Authorisation | Article 57 criteria, then the Candidate List, then Annex XIV | Identification as a substance of very high concern | After the sunset date the use needs an authorisation | SVHC Candidate List, REACH Annex XIV Authorisation List |
| 4. Restriction | Annex XVII sets a limit for a named use or article type | A restriction dossier and a Commission regulation | A hard concentration limit from a fixed date | REACH Annex XVII restrictions on plastic additives |
REACH status verified 22 September 2026. Annex XIV holds 59 entries and Annex XVII entries are numbered up to 83 (entry 83, 2,4-dinitrotoluene, Regulation (EU) 2026/859).
What Is REACH, and Does It Apply to Plastic Additives?#
REACH is Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals, and it applies to a plastic additive as a chemical substance, wherever that substance later ends up. Registration attaches to the substance, not to the compounder who buys it already registered, and the threshold is 1 tonne a year or more per manufacturer or importer. An article needs its own registration only where release of a substance is intended under Article 7(1), so most moulded plastic parts carry no registration duty of their own; the duty stays upstream, with whoever places the additive substance on the market. Plastic additives sit inside that supply chain as the registered layer beneath an exempt polymer. The complete plastic additives reference treats every listed substance as a REACH entity first and a function second.
Why the Additive Carries the REACH Duty and the Polymer Does Not#
Polymers are exempt from REACH registration under Article 2(9), so in a plastic compound the registration duty falls entirely on the additives, the monomers and the residues. ECHA's own accounting of plastic additives under REACH borrows the food-contact definition of an additive from Article 3(7) of Regulation (EU) No 10/2011 and counts only the registrations above 100 tonnes a year, which is why its Plastic Additives Initiative reads as a REACH exercise even though the trigger definition comes from a different regulation.
For a compounder, the practical effect is a mismatch between weight and duty. A rigid PVC compound formulated to 108.03 phr total, of which the resin itself contributes 92.57 wt% of the finished material, is mostly an exempt polymer surrounded by a small number of registered substances: a heat stabilizer, a lubricant, an impact modifier, a pigment. None of that changes because the additives are a minority by weight. Each one still needs its own registration, its own dossier and its own tonnage band, calculated separately from the polymer that carries it.
Substance, Mixture and Article: Which REACH Duty Attaches to Which Object#
REACH recognises 3 legal objects inside one moulded 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 one attracts a different duty. A substance is registered by whoever manufactures it in or imports it into the European Union. A mixture, such as a masterbatch or a compound, is not itself registered; instead, each substance inside it must already be registered for that use. An article, such as a moulded housing or an extruded profile, triggers its own registration only where a substance is intended to be released from it, but it still carries the Article 7(2) notification duty and the Article 33 communication duty once a Candidate List substance inside it passes 0.1 % by weight.
| You are | What you place on the market | Registration duty | Other duties |
|---|---|---|---|
| EU manufacturer of the additive | A substance | Register at 1 t/y or more | Full dossier and exposure scenarios |
| EU importer of the neat additive | A substance | Register at 1 t/y or more | Full dossier and exposure scenarios |
| EU importer of a masterbatch or compound | A mixture | Register each substance in it at 1 t/y or more | Art. 33 communication and SCIP above 0.1 % w/w once the part is an article |
| EU importer of a finished plastic part | An article | Only where release is intended (Art. 7(1)) | Art. 7(2) notification above 0.1 % w/w and 1 t/y, Art. 33 communication, SCIP |
| EU compounder using a registered additive | A mixture | None of its own | Use must be covered by the registrant's registered uses |
An importer who buys a masterbatch rather than a neat additive is importing a mixture, and the substances that make up that mixture must still be registered by someone in the supply chain for that use, normally the additive manufacturer or an earlier importer in the chain. The duty does not disappear because the substance arrives pre-dispersed in a carrier resin; it only moves to whichever object the importer is actually placing on the market. An imported finished article follows the same logic in reverse: registration is not usually required, but the Article 7(2) notification and the Article 33 communication apply once release is intended or the 0.1 % threshold is crossed, and that duty falls on the EU importer of the article.
Is REACH Compliance Mandatory?#
Yes: REACH is a regulation, not a set of guidelines, and an unregistered additive at or above 1 tonne a year simply may not be manufactured in or imported into the European Union. Registration is not advisory: it is a legal precondition for placing the substance on the market, and manufacture or import without it is unlawful regardless of how the additive performs. "REACH guidelines" is a common but wrong phrase: what exists is the regulation itself, plus four processes, registration, evaluation, authorisation and restriction, that each produce binding legal consequences rather than recommendations. A supplier who describes REACH as a set of guidelines is describing a document that does not exist.
Is There Going to Be a REACH Revision in 2026?#
No: the European Commission confirmed on 27 April 2026 that it will not table a full revision of REACH, which removes the polymer registration requirement that consultancies had been preparing for since 2023. Simplification proceeds instead through targeted, comitology-level amendments of the regulation's annexes rather than a new overarching act, so individual Annex XIV and Annex XVII changes continue on their normal schedule while the framework itself stays as it is. For a compounder, the practical consequence is that no new registration duty attaches to the polymer resin itself: the duties already established for additives, monomers and residues are unchanged. Consultancy pages published before April 2026 still describe polymer registration as an "upcoming" requirement; that description is out of date the moment it is checked against the Commission's statement.
The 4 REACH Processes That Decide Whether an Additive Can Be Used#
The 4 REACH processes are registration, evaluation, authorisation and restriction, and they escalate: registration lets an additive onto the market, evaluation asks questions about it, authorisation can close a use after a fixed date, and restriction sets a hard limit in law. Each process can stop an additive at a different point in its life on the market, and each one produces a different kind of evidence: a dossier, a data request, a Candidate List entry, or a concentration limit. An additive can sit at the first stage for decades, or it can move through all four within a single regulatory cycle, as UV-328 did between its 2014 Candidate List listing and its 2023 Annex XIV sunset date. The order below follows the legal sequence, from the lightest duty to the hardest limit.
1. Registration: 1 Tonne a Year, Tonnage Bands and the Additive Inside a Masterbatch#
Registration is the entry ticket: any plastic additive manufactured in or imported into the European Union at 1 tonne a year or more per manufacturer or importer must be registered with ECHA before it is placed on the market. The obligation is banded by tonnage, and each band raises the data requirement under REACH Annexes VII to X: 1 to 10 tonnes a year needs the smallest dossier, 10 to 100 tonnes a year and 100 to 1,000 tonnes a year add physicochemical and toxicological studies, and 1,000 tonnes a year or more requires the full Annex X data set, including long-term studies. The phase-in registration deadlines for substances already on the market before REACH entered into force fell on 30 November 2010, 31 May 2013 and 31 May 2018, staggered by hazard and tonnage; an additive registered for the first time today has no phase-in period and must be registered before manufacture or import begins.
An importer who buys an additive already dispersed in a masterbatch is importing a mixture, not a substance, but the substances inside that mixture still need their own registration. In practice the additive manufacturer or an earlier importer in the chain holds that registration, and the masterbatch importer's duty is to confirm it covers the intended use rather than to register the substance again.
A registration proves that a dossier exists and that ECHA has not rejected it; it does not prove the substance is safe, low-hazard or free of Candidate List status, since those are separate questions answered by evaluation and authorisation. Registration is also per actor and per use: a registration held by one supplier does not extend to the same substance bought from a different supplier, and a registered use does not cover a use outside its exposure scenarios. High-volume plastic antioxidants illustrate the scale involved: Irganox 1010 and Irganox 1076 are each registered at 10,000 tonnes a year or more in the European Union, and Irgafos 168 and BHT each fall in the 10,000 to 100,000 tonnes a year band.
2. Evaluation: Dossier Checks, Substance Evaluation and CoRAP#
Evaluation is the step where the authorities read what was registered: ECHA checks dossiers for compliance, and a member state can take a whole substance into a rolling action plan when a use pattern or a hazard flag suggests a risk. Dossier evaluation is ECHA's own compliance check on the registration itself, testing whether the data submitted actually meets the requirement for that tonnage band. Substance evaluation is different: a member state authority examines the substance as a whole, across every registrant and every use, under the Community rolling action plan, known as CoRAP.
BHT, the phenolic antioxidant used across polyolefins and rubber, is the plastics-relevant worked example of this second arm. BHT entered CoRAP in 2016 and remains under REACH substance evaluation for its endocrine-disrupting properties; the same substance also sits on the European Commission's 2019 priority list of substances suspected of endocrine-disrupting activity and on EDlists List II. None of this amounts to a classification or a restriction; BHT's status today is under evaluation, a holding position that can lead in either direction.
Evaluation is the usual route into the next two processes. A substance evaluation that confirms a hazard typically feeds either an Article 59 identification, which starts the authorisation route, or a restriction dossier under Annex XV; the Candidate List and Annex XVII entries on this page each trace back to a dossier or a substance evaluation that came before them.
3. Authorisation: The Article 57 Criteria, the Candidate List and Annex XIV Sunset Dates#
Authorisation is the slow route: a substance that meets one of the Article 57 criteria is identified under Article 59, enters the SVHC Candidate List, and may then be moved by the Commission to Annex XIV, the Authorisation List, which currently holds 59 entries. Article 57 sets 6 criteria, and a substance needs to meet only one of them: (a) carcinogenic category 1A or 1B, (b) mutagenic category 1A or 1B, (c) toxic for reproduction category 1A or 1B, (d) persistent, bioaccumulative and toxic (PBT), (e) very persistent and very bioaccumulative (vPvB), and (f) an equivalent level of concern, a catch-all that now covers endocrine-disrupting properties for human health and for the environment, respiratory sensitisation and specific target organ toxicity after repeated exposure. The Candidate List itself grows in batches, normally in January and June; the current total and the last inclusion date are kept on our SVHC Candidate List page, since the count changes between updates.
Once the Commission moves a Candidate List substance to Annex XIV, every entry carries two dates rather than one: a latest application date, by which an authorisation application must be filed to keep supplying the use, and a sunset date, after which the use is unlawful without a granted authorisation. UV-328, the benzotriazole UV absorber, illustrates the pattern at entry 51: latest application date 27 May 2022, sunset date 27 November 2023. DOTE, the organotin heat stabilizer, sits at entry 58 with a latest application date of 1 November 2023 and a sunset date of 1 May 2025. Sunset dates are not always final: the DEHP authorisation for medical devices was reset under Regulation (EU) 2023/2482 to a latest application date of 1 January 2029 and a sunset date of 1 July 2030, a sector-specific extension that shows the route can be reopened. Every plastics entry and its sunset date is listed on REACH Annex XIV Authorisation List.
An authorisation, once granted, is not permanent either. The Commission's 2016 authorisation for lead chromate uses was annulled by the General Court on 7 March 2019 (T-837/16), and the appeal against that annulment was dismissed by the Court of Justice on 25 February 2021 (C-389/19 P), which shows that an authorisation decision remains open to legal challenge after it is granted.
4. Restriction: Annex XVII and the Entries That Hit Plastics#
Restriction is the fast route and the hard one: an Annex XVII entry sets a concentration limit for a named substance in a named use or article type, it applies from a fixed date, and there is no application procedure to escape it. Annex XVII entries are numbered up to 83, with entry 83, 2,4-dinitrotoluene, added most recently by Regulation (EU) 2026/859; unlike authorisation, a restriction needs no dossier from the company affected and carries no sunset date to apply for.
Thirteen Annex XVII entries reach plastic additives directly: entry 20 (organotins), entry 23 (cadmium), entries 28 to 30 (CMR substances supplied to the general public in mixtures), entries 46 and 46a (nonylphenol and its ethoxylates), entry 50 (8 polycyclic aromatic hydrocarbons), entry 51 (DEHP, DBP, BBP, DIBP), entry 52 (DINP, DIDP, DNOP), entry 63 (lead in PVC), entry 68 (C9 to C14 PFCAs), entry 70 (D4, D5 and D6 siloxanes), entry 78 (synthetic polymer microparticles), entry 79 (PFHxA) and entry 82 (PFAS in firefighting foams). Restriction is the fast route in practice too: entry by entry, with the derogations, the full picture is set out on REACH Annex XVII restrictions on plastic additives.
Entry 78 is the restriction most likely to reach every compounder, regardless of the additive family they use, because it does not target a hazard class but a physical form: synthetic polymer microparticles. Pellets, flakes and powders used at industrial sites carry a derogation from the concentration limit itself, but from 17 October 2025 suppliers of those materials must provide instructions for use and disposal, a standard entry 78 statement, the quantity or concentration of polymer present, and the generic polymer identity. Annual reporting to ECHA on the same materials is due by 31 May, starting in 2026 for manufacturers and industrial downstream users of feedstock pellets, flakes and powders, and from 2027 for other suppliers. Additive-side products caught by these duties include micronised polyethylene and polypropylene waxes, PTFE micropowder, PMMA and silicone beads, and expandable microspheres, all of which are polymeric powders in their own right before they are additives.
Which Plastic Additives Does REACH Already Control?#
REACH already names plastic additives from 16 families, from ortho-phthalate plasticizers and lead heat stabilizers to benzotriazole UV absorbers, brominated flame retardants, cadmium pigments and the polymer powders caught by the microplastics entry. The table below lines up, in the site's standard family order, every substance group REACH has already identified, the exact instrument and entry number behind it, the limit or effect that follows, and the date it started to apply. No new fact appears in the table: every value repeats a claim already established in the registration, evaluation, authorisation and restriction sections above, arranged by family instead of by process.
| # | Family | Substances | Instrument and entry | Limit or effect | From | Guide |
|---|---|---|---|---|---|---|
| 1 | Ortho-phthalate plasticizers | DEHP, DBP, BBP, DIBP | Candidate List 2008 and 2010; Annex XIV entries 4 to 7 (sunset 21 Feb 2015); Annex XVII entry 51 | 0.1 % by weight of the plasticised material, individually or combined, in all articles | 7 Jul 2020 | phthalate restrictions worldwide |
| 2 | Ortho-phthalate plasticizers in toys | DINP, DIDP, DNOP | Annex XVII entry 52 | 0.1 %, only in toys and childcare articles that can be placed in the mouth. DINP is not banned in the EU | 16 Jan 2007 | see row 1 |
| 3 | Lead heat stabilizers | Tribasic lead sulfate, dibasic lead phosphite, dibasic lead stearate, C16-18 lead salts | Candidate List 19 Dec 2012; Annex XVII entry 63 | Below 0.1 % Pb in PVC articles; recovered rigid PVC up to 1.5 % until 28 May 2033 | 29 Nov 2024 | lead in PVC: REACH restriction (entry 63) |
| 4 | Organotin heat stabilizers | DOTE, the DOTE/MOTE reaction mass, dibutyltin and dioctyltin compounds | Annex XIV entries 58 and 59 (sunset 1 May 2025); Annex XVII entry 20 | 0.1 % Sn by weight in listed consumer articles | 1 Jan 2012 and 1 May 2025 | organotin restrictions: REACH entry 20 |
| 5 | Benzotriazole UV absorbers | UV-320, UV-327, UV-328, UV-350; UV-326 and UV-329 | Annex XIV entries 51 to 54 (sunset 27 Nov 2023); Candidate List 23 Jan 2024 for UV-326 and UV-329 | Use in the EU needs an authorisation after the sunset date | 27 Nov 2023 | benzotriazole UV absorbers: SVHC, Annex XIV and POPs status |
| 6 | Brominated flame retardants | HBCDD, decaBDE, TBBPA, BTBPE, TBPH, DBDPE | Annex XIV entry 3 (HBCDD); Candidate List 2012, 2023 and 5 Nov 2025 | SVHC duties above 0.1 % w/w in an article | Various | EU restriction of aromatic brominated flame retardants |
| 7 | Chlorinated paraffins | SCCP, MCCP | Candidate List 28 Oct 2008 and 8 Jul 2021 | SVHC duties above 0.1 % w/w; both are also POPs | 2008 and 2021 | POPs in plastics |
| 8 | Phosphorus flame retardants and phosphate plasticizers | TCEP, trixylyl phosphate, triphenyl phosphate | Annex XIV entries 13 and 47; Candidate List 7 Nov 2024 for triphenyl phosphate | Authorisation after sunset; SVHC duties for triphenyl phosphate | 2015, 2023, 2024 | triphenyl phosphate |
| 9 | Antioxidants | Antioxidant 2246 (DBMC), TNPP containing 0.1 % or more 4-nonylphenol | Candidate List 17 Jan 2022 and 16 Jul 2019 | SVHC duties above 0.1 % w/w | 2019 and 2022 | SVHC Candidate List |
| 10 | Crosslinking peroxides and silanes | Dicumyl peroxide, tris(2-methoxyethoxy)vinylsilane | Candidate List 27 Jun 2024 and 17 Jan 2022; Annex XVII entries 28 to 30, Appendix 6 | SVHC duties; not to be supplied to the general public in mixtures above the concentration limit | 2022 and 2024 | dicumyl peroxide |
| 11 | Lead and cadmium pigments | Lead chromate, lead sulfochromate yellow (PY34), lead chromate molybdate sulfate red (PR104), cadmium sulphide | Annex XIV entries 10 to 12 (sunset 21 May 2015); Annex XVII entry 23 | Below 0.01 % Cd by weight in the listed plastics; authorisation for the lead chromates | 21 May 2015 and 10 Dec 2011 | lead chromate |
| 12 | Carbon black and extender oils | 8 polycyclic aromatic hydrocarbons | Annex XVII entry 50 | 1 mg/kg each in rubber or plastic parts with skin or mouth contact; 0.5 mg/kg in toys and childcare articles | 27 Dec 2015 | carbon black in plastics |
| 13 | Blowing agents | Azodicarbonamide | Candidate List 19 Dec 2012 (respiratory sensitiser) | SVHC duties above 0.1 % w/w | 19 Dec 2012 | azodicarbonamide (ADCA) |
| 14 | Fluoropolymer processing aids and PTFE | C9 to C14 PFCAs; PFHxA and related substances | Annex XVII entries 68 and 79 | 25 ppb sum and 260 ppb related (entry 68); 25 ppb and 1,000 ppb (entry 79) | 25 Feb 2023 and 10 Oct 2026 | PFAS restrictions and plastic additives |
| 15 | Silicone release agents and processing aids | D4, D5 and D6 cyclosiloxanes | Candidate List 27 Jun 2018; Annex XVII entry 70 | 0.1 % in consumer and professional mixtures | 6 Jun 2026 | named only |
| 16 | Polymeric powder additives and waxes | Micronised PE and PP waxes, PTFE micropowder, PMMA and silicone beads, expandable microspheres | Annex XVII entry 78 | 0.01 % by weight; industrial-site derogation with information duties from 17 Oct 2025 and annual reporting by 31 May from 2026 | 17 Oct 2023, staged | EU microplastics restriction (REACH entry 78) |
A Candidate List entry is not a ban. It creates the communication, notification and database duties in the next section. An Annex XIV entry stops a use after its sunset date unless an authorisation is granted. Only an Annex XVII entry is a direct limit.
Each substance named above has its own regulatory matrix in the plastic additives database, and the full plastic additives database cross-references every entry in this table against its dosage, its function and every other rule that applies to it.
What Must You Do When an Additive Is on the SVHC Candidate List?#
Four duties follow automatically the day an additive enters the SVHC Candidate List, and none of them waits for an authorisation decision: communication to recipients, notification to ECHA, a SCIP entry and a safety data sheet on request. In order of how soon each one falls due:
- Communication to recipients (Article 33), immediately on Candidate List inclusion
- Notification to ECHA (Article 7(2)), within 6 months of inclusion
- SCIP database entry (Article 9(1)(i) of the Waste Framework Directive), before the article is placed on the market
- Safety data sheet on request (Article 31(3)), for a qualifying mixture
| Duty | Legal basis | Trigger | Deadline |
|---|---|---|---|
| Communication to recipients | Article 33 | 0.1 % w/w or more of a Candidate List substance in an article | Immediately on Candidate List inclusion; consumer requests answered within 45 days |
| Notification to ECHA | Article 7(2) | 0.1 % w/w or more and more than 1 tonne a year per actor | Within 6 months of Candidate List inclusion |
| SCIP database entry | Article 9(1)(i), Waste Framework Directive | 0.1 % w/w or more of a Candidate List substance in an article | Since 5 January 2021, before the article is placed on the market |
| Safety data sheet on request | Article 31(3) | 0.1 % or more of a Candidate List substance in a non-classified mixture | On request |
These four duties sit outside the authorisation timeline entirely: a substance can carry them for years while its Annex XIV fate is still undecided. The SVHC Candidate List itself grows in batches, normally in January and June, so the current total and the last inclusion date are not fixed figures; they are kept current on our SVHC Candidate List page, along with the full list of plastic additives it names. Candidate List status also reaches beyond REACH: it defines a "substance of concern" under the Ecodesign for Sustainable Products Regulation, a definition the Packaging and Packaging Waste Regulation reuses without change.
Communication Duties: Article 33, SCIP and the Safety Data Sheet#
Article 33 obliges the supplier of an article that contains a Candidate List substance above 0.1 % by weight to pass on enough information for safe use, and at minimum the name of the substance. The obligation runs down the supply chain in stages that mirror the legal objects REACH already defines: the additive supplier tells the compounder, the compounder tells the converter, and the converter tells the brand owner, because each one supplies a different mixture or article and each duty resets at that boundary. A consumer who asks a supplier whether an article contains a Candidate List substance above 0.1 % is entitled to an answer within 45 days, free of charge, without buying anything.
The SCIP database adds a second, more structural duty on top of Article 33. Since 5 January 2021, any supplier placing an article containing a Candidate List substance above 0.1 % by weight on the EU market must notify that article to ECHA's SCIP database before it reaches the market, under Article 9(1)(i) of the Waste Framework Directive; the notification exists so that waste operators, not only downstream buyers, know what a discarded article contains.
A safety data sheet fills a narrower gap: Article 31(3) requires one on request for a mixture that is not itself classified as hazardous but contains 0.1 % or more of a Candidate List substance. What the sheet must contain, and how it differs from the labelling triggered by CLP classification, is set out on safety data sheets and GHS labels for plastic additives.
What Is a REACH Declaration of Conformity or a REACH Certificate?#
REACH issues no certificate: a "REACH declaration of conformity" is a supplier statement, not a regulatory document, and its value depends entirely on what it says. What actually exists under REACH is the Article 33 information duty, the registration itself, and, where a mixture qualifies, the safety data sheet described above; none of the three is a certificate and none carries an official seal. A statement worth relying on names the Candidate List substances present above 0.1 % by weight, states the registration status of each substance for the buyer's intended use, and gives the SCIP reference where the item in question is an article. Because the Candidate List changes in January and June, that statement is only useful if it is dated; an undated declaration cannot be checked against the list it claims to reflect.
The 0.1 % Rule Applies to Each Component Article, Not the Whole Product#
The 0.1 % threshold is calculated on each component article, not on the finished product, so diluting a restricted plasticizer across the total weight of an appliance is not a defence. This reading comes from the Court of Justice of the European Union in C-106/14 (FCD and FMB, 10 September 2015), summarised in the industry as "once an article, always an article": a complex product assembled from several component articles stays several articles for REACH purposes, even after assembly, and each component is checked against 0.1 % on its own weight rather than against the weight of the whole.
A plastics example makes the arithmetic concrete. A single appliance built from a plasticized gasket, a cable jacket and a moulded housing contains three separate articles under this reading, not one. A gasket that weighs a small fraction of the appliance's total mass can still breach the 0.1 % threshold entirely on its own, because the calculation never spreads its plasticizer content across the housing or the cable jacket next to it. Averaging the additive load across the finished product, a common but incorrect shortcut, understates the true concentration in the one component that actually carries it.
What Does ECHA Know About Plastic Additives Under REACH?#
ECHA's Plastic Additives Initiative maps 418 additives that are registered under REACH above 100 tonnes a year, and the largest single function in it is not a stabilizer or a plasticizer but pigments, with 127 substances. The exercise reuses the additive definition from Article 3(7) of Regulation (EU) No 10/2011, the EU food-contact plastics regulation, and applies it inside REACH's own registration data, which is why a dataset built for one regulation ends up describing another. It sorts every registered use into 11 polymer categories, Polyolefin-I, Polyolefin-II, soft PVC, rigid PVC, PUR, ABS, PET, PMMA, PA, PC and expandable polystyrene, so one additive can appear against several categories at once.
| Function in ECHA's mapping list | Substances | Share of the 418 | Family hub on this site |
|---|---|---|---|
| Pigment | 127 | 30.4 % | Pigments and colorants |
| Other function | 74 | 17.7 % | Various |
| Plasticiser | 66 | 15.8 % | Plasticizers |
| Flame retardant | 39 | 9.3 % | Flame retardants |
| Heat stabiliser | 27 | 6.5 % | Heat stabilizers |
| Antioxidant | 26 | 6.2 % | Antioxidants |
| Other stabiliser | 22 | 5.3 % | UV and other stabilizers |
| Light stabiliser | 16 | 3.8 % | UV stabilizers |
| Antistatic agent | 16 | 3.8 % | Antistatic agents |
| Nucleating agent | 5 | 1.2 % | Nucleating and clarifying agents |
| Total | 418 | 100 % |
Lubricants and fillers were excluded from the exercise because few registrations report a use in plastic articles, so their absence is a scoping decision, not a sign that they are unregistered.
The 418 rows are a lower bound, not a full inventory of plastic additives in commercial use. The mapping covers only registrations above 100 tonnes a year, so any additive used below that threshold, however common, is absent from it by design. ECHA's own summary describes the count as "over 400" rather than the exact 418 the row-by-row data supports, and the source read for this page is an archived copy of the ECHA page taken on 28 August 2025, so a newer ECHA update could move the individual counts without changing the overall shape of the list.
How REACH Fits the Other Plastic Additive Regulations#
REACH is the horizontal layer of EU chemicals law: it decides what may be made, imported and used as a substance, and the product rules then decide, separately, what may go into a food package, a toy, an electronic enclosure or a medical device. CLP, Regulation (EC) No 1272/2008, sits alongside REACH as the other horizontal layer, supplying the hazard classifications that REACH's own Annex XVII entries and the product rules both draw on. Food contact, packaging, toys, electronics and medical devices form the vertical layer: each one reuses REACH and CLP categories but adds its own positive list, migration limit or product-specific rule on top. A Stockholm Convention listing can override REACH entirely: decaBDE left Annex XVII when it moved to the POPs Regulation, and UV-328 now carries both an Annex XIV entry and a POPs listing at the same time. Every one of these plastic additive regulations, horizontal and vertical alike, traces back to the same registration REACH created in the first place, and all five layers of plastic additive regulations are indexed on the parent guide.
What Is the Difference Between RoHS and REACH?#
RoHS and REACH overlap on four phthalates and diverge on everything else: RoHS, Directive 2011/65/EU, restricts 10 substances in electrical and electronic equipment per homogeneous material, while REACH covers every substance in every sector and measures the same 0.1 % against the component article. RoHS Annex II sets a 0.1 % limit for lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP and DIBP, and a 0.01 % limit for cadmium, each calculated against a homogeneous material, the smallest single material that can be mechanically separated from a product, rather than against a component article as REACH does. The four phthalate limits have applied in general electrical and electronic equipment since 22 July 2019, and in medical devices, in-vitro diagnostic devices and monitoring and control instruments since 22 July 2021.
REACH covers considerably more ground than that overlap suggests. It applies to every sector, not only electronics, it creates the Article 33 and SCIP communication duties that RoHS does not, and it can add a substance through the Candidate List or Annex XVII years before RoHS Annex II is amended to match it. RoHS and plastic additives sets out the full 10-substance list, the homogeneous-material test and every compliance route an electronics compounder needs alongside this page.
Where REACH Stops: Food Contact, CLP and Product Rules#
REACH does not authorise anything for food contact: an additive that is registered, unlisted as an SVHC and unrestricted can still be unlawful in a food-contact plastic, because Regulation (EU) No 10/2011 is a positive list and anything not on it is prohibited. The food-contact regulation works entirely separately from REACH's own duties: it assigns each authorised substance an FCM number, sets a generic specific migration limit of 60 mg/kg where no substance-specific limit applies, an overall migration limit of 10 mg/dm2 (60 mg/kg for infant food), and a functional-barrier detection limit of 0.01 mg/kg for substances kept from the food side by a barrier layer. EU 10/2011 covers the full Union list, every migration limit and the functional-barrier route in detail.
CLP, Regulation (EC) No 1272/2008, supplies the harmonised classifications that both REACH and the product rules build on; without a CLP classification, several Annex XVII entries, including entries 28 to 30 on CMR substances in consumer mixtures, would have nothing to trigger against. Delegated Regulation (EU) 2023/707 added new hazard classes to CLP, among them endocrine disruption for human health and for the environment, persistent-bioaccumulative-toxic (PBT), very-persistent-very-bioaccumulative (vPvB), persistent-mobile-toxic (PMT) and very-persistent-very-mobile (vPvM); these apply to substances from 1 May 2025 and to mixtures from 1 May 2026, and each new class can in turn justify a future Candidate List entry.
Product rules add a final layer on top of both. The Ecodesign for Sustainable Products Regulation defines a "substance of concern" starting from the Candidate List, a definition the Packaging and Packaging Waste Regulation reuses without changing it, so a REACH Candidate List entry now has consequences under product law that have nothing to do with REACH's own four processes. The new hazard classes are explained on CLP classification of plastic additives.
REACH Dates for Plastic Additives in 2026 and 2027#
Six dated REACH obligations fall on plastics between May 2026 and October 2027, and the two nearest are both compounding-plant duties: the recovered-PVC loop closes on 28 May 2026 and the first microplastics report is due to ECHA by 31 May 2026.
| Date | REACH instrument | What applies | Who it hits | Status |
|---|---|---|---|---|
| 28 May 2026 | Annex XVII entry 63 | Recovered rigid PVC from categories (a) to (d) may return only into those same categories | Recyclers and compounders using recovered PVC | Dated |
| 31 May 2026 | Annex XVII entry 78 | First annual report to ECHA on synthetic polymer microparticles | Manufacturers and industrial downstream users of feedstock pellets, flakes and powders | Dated |
| 6 Jun 2026 | Annex XVII entry 70 | D4, D5 and D6 cyclosiloxanes limited to 0.1 % in consumer and professional mixtures | Silicone release agent and processing aid suppliers | Dated |
| 10 Oct 2026 | Annex XVII entry 79 | PFHxA and related substances limited in consumer textiles, footwear, paper food-contact material, consumer mixtures and cosmetics | Fluoropolymer processing aid and PTFE suppliers | Dated |
| 31 May 2027 | Annex XVII entry 78 | Second annual reporting round, extended to other industrial users and suppliers | Wider set of polymer powder suppliers | Dated |
| 17 Oct 2027 | Annex XVII entry 78 | Next staged reporting date, for rinse-off cosmetics | Cosmetics formulators, not a plastics-compounding date | Dated |
| Not dated | 13th Annex XIV recommendation | UV-326, UV-329, triphenyl phosphate and photoinitiator 379 proposed for authorisation | Benzotriazole UV absorber and phosphate ester suppliers | PENDING |
| Not dated (dossier expected Dec 2026) | Aromatic brominated flame retardant restriction | Annex XV restriction dossier | Brominated flame retardant suppliers | PENDING |
| Not dated | Universal PFAS restriction | Restriction covering the PFAS class | Fluoropolymer and PFAS-containing additive suppliers | PENDING |
| Not dated | PVC and additives investigation follow-up | Commission response to ECHA's November 2023 investigation, which recommended a restriction on ortho-phthalate plasticisers and organotin stabilisers rather than on PVC itself | PVC compounders | PENDING |
Four further items touch plastics but carry no fixed date: the final 13th Annex XIV recommendation, the Annex XV dossier on aromatic brominated flame retardants, the universal PFAS restriction and the Commission's follow-up to ECHA's PVC and additives investigation are all still pending, and none of them should be read as already in force.
How Do You Check the REACH Status of One Additive? 6 Steps#
Check the REACH status of a plastic additive in 6 steps: identify it by CAS number, confirm the registration covers your use, check the Candidate List, check Annex XIV, check Annex XVII for your article type, then recalculate the 0.1 % per component article.
- Identify the substance by CAS and EC number, not by trade name, because one trade name can cover a reaction mass or a group entry.
- Check whether it is registered for your use, and ask the supplier for the registration that covers that specific use rather than any registration of the same substance.
- Check the SVHC Candidate List, including group entries such as "PFBS and its salts" and "fatty acids, C16-18, lead salts", which catch substances that are never listed individually.
- Check Annex XIV for a latest application date and a sunset date, and confirm whether the sunset date has already passed for your use.
- Check Annex XVII for an entry that covers your article type, and read its derogations, because entry 51 exempts food-contact materials, medical devices and equipment covered by RoHS.
- Recalculate the 0.1 % threshold on each component article separately, then write the dated supplier statement described earlier on this page.
Trade names are the most common failure point in this process. "DOP" and "dioctyl phthalate" in trade usage both mean DEHP, CAS 117-81-7, not DNOP, CAS 117-84-0, a different phthalate with a different Annex XVII entry. DOTP, also called DEHT, CAS 6422-86-2, is a terephthalate and not an ortho-phthalate at all, so entry 51 does not reach it. Chimassorb 944 carries two CAS numbers depending on jurisdiction, 71878-19-8 in the EU and 70624-18-9 in the US, and Tinuvin 292 and Tinuvin 765 are the same reaction mass, CAS 1065336-91-5, sold under two trade names. Running the same 6 checks automatically, rather than by hand for every additive in a formulation, is what the additive regulatory status checker does.
What to Do When an Additive You Use Is Restricted: Selecting a Replacement#
A restriction is a formulation problem before it is a legal one, and the replacement has to survive the same 6 checks that the restricted additive failed. Two substitutions are already settled in plastics formulation practice. DEHP in flexible PVC is replaced by DOTP, DINCH, TOTM or DINP, depending on the application; none of those four substances appears on the Candidate List today. Lead heat stabilizers are replaced by calcium-zinc systems, which together with calcium-organic systems now account for 83 % of EU stabilizer use, according to VinylPlus's 2023 summary of its contribution to ECHA's PVC and additives investigation.
Choosing a replacement only to leave a Candidate List entry behind is how regrettable substitution happens: a replacement selected on that basis alone can carry the same hazard under a different CAS number. The full framework for how to select plastic additives runs the replacement through the same 6-step check as the original, plus its food-contact and product-rule status, before it goes into a formulation.
Does a REACH Restriction Mean the Additive Is Toxic?#
A REACH restriction records a hazard and a use, not a verdict on toxicity: UV-326, UV-329, BTBPE, TBPH and DBDPE are on the Candidate List because they are very persistent and very bioaccumulative, not because they are classified as toxic to people. Three of the six Article 57 criteria, PBT, vPvB and the equivalent-level-of-concern catch-all, are hazard properties that a substance can meet without carrying any classified human health hazard at all; persistence and bioaccumulation describe what a substance does in the environment over time, not what it does inside a human body on contact. The reverse also happens, and just as publicly: the harmonised carcinogen category 2 classification of titanium dioxide was annulled by the General Court on 23 November 2022, and that annulment was upheld by the Court of Justice on 1 August 2025, so a hazard classification is not a permanent verdict either, in either direction. Which additives really carry a health classification, distinct from an environmental one, is set out on toxic plastic additives.
Is the European Union Banning Plastics?#
No: the European Union restricts named substances and named products, not plastics as a material, and the clearest example is oxo-degradable plastic, which has been banned since 3 July 2021 because of the additive in it, not because it is plastic. Every Annex XVII entry names a specific substance or substance group inside a defined article type; none of them names "plastic" as the restricted item. Article 5 of Directive (EU) 2019/904 bans products made from oxo-degradable plastic, a plastic formulated with a pro-degradant additive designed to fragment it, precisely because that additive behaviour was judged harmful, while ordinary plastic without that additive is unaffected by the same article. Entry 78 follows the same pattern on synthetic polymer microparticles deliberately added to a product, restricting the particle, not the polymer it is made from, with a derogation for industrial-site use.
What Happens to Legacy Additives Already in Products and Recycled Plastic?#
A REACH restriction applies from a date, so the additives it removes stay in the products already sold, and the clearest case is lead: recovered rigid PVC may still contain up to 1.5 % lead in listed building uses until 28 May 2033. That derogation, marked with the label "Contains at least 0.1 % lead" on the finished product, exists because rigid PVC window profiles and pipes stay in service for decades, and stripping every trace of a legacy stabilizer out of the recycling stream is not yet feasible at scale; the Commission reviews the derogation by 28 May 2028.
The pattern repeats across the wider recyclate stream. In a Swiss study of flooring, Wiesinger and colleagues (2024) found that 16 % of samples contained regulated chemicals above 0.1 % by weight, mainly lead and DEHP, both restricted for years before the products tested were made. Measured levels in recyclate, family by family, are on legacy additives in recycled plastic.
How REACH Changes Are Tracked: The Plastic Additives News Log#
This page carries a dated verification line because REACH moves in batches: the Candidate List is updated normally in January and June, and Annex XIV and Annex XVII change whenever an amending regulation reaches the Official Journal. Between those fixed points, an entry can still move: a substance can be identified under Article 59, a restriction dossier can clear the Member State Committee, or a POPs listing can take a substance out of Annex XVII entirely, as it did for decaBDE. This page's own plastic additives news tracking is how its verification date stays current between the January and June windows: every Candidate List batch and every amending regulation is logged in plastic additives news as it happens.
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