Lead in PVC is restricted across the European Union: since 29 November 2024, REACH Annex XVII entry 63 prohibits placing on the market any PVC article in which lead is present at or above 0.1 % by weight of the PVC material. That single line settles most formulations, so why does PVC carrying up to 1.5 % lead still reach building sites lawfully? The answer is the derogation for recovered rigid PVC, which runs in six named building uses until 28 May 2033.
The entry has four moving parts: one concentration limit, five dated obligations, six derogated uses and four excluded article groups. All of them were inserted as paragraphs 15 to 20 of entry 63 by Commission Regulation (EU) 2023/923 of 3 May 2023, which amended Annex XVII to Regulation (EC) No 1907/2006. That regulation is the operative instrument and the restriction dates from 29 November 2024, so neither the earlier restriction dossier nor any earlier political stage carries the duty. The four excluded groups are food contact materials, electrical and electronic equipment, packaging and toys, each governed by its own lead limit rather than by entry 63.
This page gives the compliance reading of entry 63 in the order a compounder needs it: what the restriction covers and which articles fall outside it, what the 0.1 % is measured against, the five dated obligations from 29 November 2024 to 28 May 2033, which recovered PVC may still contain lead and under what marking and evidence conditions, which lead-based additives the restriction removes from a PVC compound, a seven-step way to show compliance, the 7 EU rules that cap lead in an article containing PVC, and the calcium-zinc, organotin and organic systems that replaced lead.
Table T1: REACH entry 63 at a glance
| Field | Value |
|---|---|
| Instrument | Commission Regulation (EU) 2023/923 of 3 May 2023, amending Annex XVII to Regulation (EC) No 1907/2006 |
| Annex XVII entry and paragraphs | entry 63, paragraphs 15 to 20 |
| Substance scope | lead and its compounds, expressed as lead |
| Limit | at or above 0.1 % by weight, prohibited |
| Reference material | the PVC material of the article, not the whole article |
| Applies from | 29 November 2024 |
| Articles placed on the market before that date | not affected |
| Derogation, recovered rigid PVC | below 1.5 % lead, 6 listed uses, until 28 May 2033, marked Contains ≥ 0,1 % lead |
| Derogation, recovered flexible PVC | expired 28 May 2025 |
| Excluded article groups | food contact, electrical and electronic equipment, packaging, toys |
| Commission review | by 28 May 2028 |
All values from the Official Journal text of Commission Regulation (EU) 2023/923. Regulatory status verified 25 September 2026.
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What Does REACH Entry 63 Restrict, and Which Plastic Additives Does It Affect?#
REACH Annex XVII entry 63 prohibits placing on the market PVC articles that contain lead at or above 0.1 % by weight of the PVC material, which removes every lead-based heat stabilizer and every lead pigment from new European PVC, because a lead stabilizer only works at about 0.5 % by weight, five times the limit. The prohibition covers both placing on the market and use in PVC articles, and it names lead and its compounds together, expressed as lead.
A voluntary phase-out preceded the restriction and did not finish the job. The recital to Commission Regulation (EU) 2023/923 records that about 90 % of lead emissions from PVC articles in the European Union in 2016 came from imported articles, while the European producers organised under ESPA and VinylPlus had already completed their voluntary replacement of lead stabilizers by the end of 2015. The restriction therefore closes an import gap rather than a European production gap.
Lead salts never worked alone in a PVC compound. PVC loses hydrogen chloride slowly from 100 to 120 °C and degrades rapidly near 250 °C, and 0.1 % dehydrochlorination is already enough to cause unacceptable discoloration, so no PVC compound exists without a heat stabilizer working alongside the other plastic additives in the recipe, from lubricants and fillers to pigments. Lead salts were one family among the plastic additives in that package, and entry 63 reaches any additive in the compound that carries lead, whatever function it performs. Which articles does that duty actually bite on?
Which PVC articles entry 63 covers, and the 4 article groups it excludes#
Entry 63 covers every PVC article placed on the European Union market or used there, whatever its form and wherever it was made, with four groups of articles excluded because their lead content is governed by their own instruments. The scope is written around the material and the market, not around a sector, so a window profile, a cable sheath, a flooring sheet and an imported fitting are all inside it. The four excluded groups are listed below.
- Food contact materials and articles, covered by Regulation (EC) No 1935/2004
- Electrical and electronic equipment, covered by Directive 2011/65/EU (RoHS)
- Packaging, covered by Directive 94/62/EC
- Toys, covered by Directive 2009/48/EC
Excluded is not unregulated. Each of those four instruments sets its own lead limit on its own reference material, and the comparison section below puts the four values side by side, because exclusion from entry 63 leaves food-contact PVC and a PVC cable inside a laptop under a lead limit of their own rather than under none. One further exemption sits inside the entry itself: PVC-silica separators in lead-acid batteries are exempt until 28 May 2033, which is an exemption with an end date rather than a permanent carve-out, and it covers the separator only.
Does entry 63 apply to PVC articles placed on the market before 29 November 2024?#
No: PVC articles placed on the market before 29 November 2024 are not caught by entry 63, which is why the Official Journal text names 28 November 2024 as the last day of the previous regime. Existing stock that was already placed on the market stays lawful and may move through the distribution chain. Anything newly placed on the market from 29 November 2024 must comply, and that includes an identical article from an unchanged mould and an identical article imported from outside the European Union. The date of application is 29 November 2024 in every case, and no other date carries the duty.
What the 0.1 % limit is measured against: the PVC material, not the article#
The 0.1 % is measured against the PVC material of the article and not against the article as a whole, so a window with a steel reinforcement and a PVC profile is judged on the profile alone. Naming the reference material correctly changes the result in every composite part, because diluting a lead-bearing profile with the mass of a non-PVC component does not bring the article into compliance.
Three neighbouring instruments measure against three different materials: entry 63 against the PVC material, Annex XVII entry 23 against the plastic material for cadmium, and the RoHS Directive 2011/65/EU against each homogeneous material. The practical rule that follows is to assess a multi-material part per PVC component and a multilayer PVC part per layer wherever the entry itself distinguishes layers, as it does for decks, interior profiles and multilayer pipes. This reference states what the law measures and prescribes no sampling convention, because no sampling rule for separating the PVC material is in our verified data set.
Does the limit cover lead pigments as well as lead stabilizers?#
Yes: entry 63 limits lead and its compounds as elemental lead in the PVC material, so a lead chromate pigment counts towards the same 0.1 % as a lead stabilizer. The source of the lead inside the compound is irrelevant to the calculation. The chrome-yellow pigments had in any case left the European market earlier and by a different legal route: lead chromate (CAS 7758-97-6), lead sulfochromate yellow PY34 (CAS 1344-37-2) and lead chromate molybdate sulfate red PR104 (CAS 12656-85-8) entered the Candidate List on 13 January 2010 and then Annex XIV as entries 10 to 12 with a sunset date of 21 May 2015, and the authorisation granted in 2016 was annulled by the General Court in case T-837/16 of 7 March 2019, with the appeal dismissed in case C-389/19 P on 25 February 2021. The authorisation history of lead chromate and its two chrome-yellow derivatives is set out on its own page.
The 5 Entry 63 Deadlines from 29 November 2024 to 28 May 2033#
Entry 63 sets 5 dated obligations: the restriction applies from 29 November 2024, the derogation for recovered flexible PVC ended on 28 May 2025, the closed-loop condition for recovered rigid PVC started on 28 May 2026, the Commission must review the derogation by 28 May 2028, and the recovered rigid PVC derogation ends on 28 May 2033. The same 2033 date also ends the exemption for PVC-silica separators in lead-acid batteries.
Table T2: The 5 dated obligations of entry 63
| Date | What applies | Who it binds | Status |
|---|---|---|---|
| 29 November 2024 | Lead at or above 0.1 % by weight of the PVC material may not be placed on the market in a PVC article | Manufacturers, importers and distributors of PVC articles | applied |
| 28 May 2025 | The derogation for articles containing recovered flexible PVC ends | Recyclers and compounders using recovered flexible PVC | applied |
| 28 May 2026 | Recovered rigid PVC from derogated categories (a) to (d) may be used only for new articles of those same categories | Recyclers, profile and sheet extruders | applied |
| 28 May 2028 | The Commission must review the recovered-PVC derogation | European Commission | scheduled by entry 63 |
| 28 May 2033 | The 1.5 % derogation for recovered rigid PVC ends, and the exemption for PVC-silica separators in lead-acid batteries ends | Recyclers, building-product makers, battery makers | scheduled by entry 63 |
Status as of 18 October 2026. All dates from the Official Journal text of Commission Regulation (EU) 2023/923.
Three of the five dates have already passed, so the live obligations for a compounder are the closed-loop channelling of recovered rigid PVC and the 2033 expiry, and both belong in the quality plan as re-check dates rather than as one-off actions.
Which Recycled PVC May Still Contain Lead?#
Only recovered rigid PVC may still contain lead, below 1.5 % by weight of the recovered rigid PVC, in 6 listed building uses and only until 28 May 2033. The permission is use-bound: outside the six uses, recovered rigid PVC meets the same 0.1 % limit as virgin material, and inside them it must still carry a marking and documentary evidence.
The derogation exists because of what Europe built. Lead salts went into European rigid PVC profiles, sheets and pipes for decades, so post-consumer window and pipe streams carry legacy lead that cannot be extracted from the material, and the derogation keeps that material inside a controlled loop instead of sending it to landfill or incineration. Recycled plastics carry their own additive demand, and restabilizing a post-consumer stream is the subject of additives for recycled plastics, which covers the antioxidant and stabilizer package that recyclate needs whatever metal it contains. The 1.5 % is measured against the recovered rigid PVC fraction, not against the finished article and not against the whole compound, which is the distinction most often lost in summaries of the entry.
Table T3: The 6 derogated recovered rigid PVC uses
| # | Derogated use | Condition in the entry | Lead limit | Closed loop from 28 May 2026 | Ends |
|---|---|---|---|---|---|
| (a) | Exterior profiles and sheets, excluding decks | none beyond the use restriction | below 1.5 % of the recovered rigid PVC | yes | 28 May 2033 |
| (b) | Decks | the recovered PVC must be in a middle layer that is fully covered | below 1.5 % | yes | 28 May 2033 |
| (c) | Concealed spaces | the article is not accessible in normal use | below 1.5 % | yes | 28 May 2033 |
| (d) | Interior profiles | surface layer with lead below 0.1 % | below 1.5 % | yes | 28 May 2033 |
| (e) | Multilayer pipes, not for drinking water | the recovered PVC must be in the middle layer | below 1.5 % | no | 28 May 2033 |
| (f) | Fittings, not for drinking water | none beyond the use restriction | below 1.5 % | no | 28 May 2033 |
All six uses additionally require the marking Contains ≥ 0,1 % lead. The limit applies to the recovered rigid PVC, not to the finished article. Source: Official Journal text of Commission Regulation (EU) 2023/923.
The 6 recovered rigid PVC uses that keep the 1.5 % derogation until 28 May 2033#
The derogation covers 6 uses of recovered rigid PVC: exterior profiles and sheets other than decks, the covered middle layer of decks, concealed spaces, interior profiles carrying a surface layer below 0.1 % lead, the middle layer of multilayer pipes not intended for drinking water, and fittings not intended for drinking water. Each use carries its own condition, in the order the Official Journal sets them.
- (a) Exterior profiles and sheets, decks excluded. No condition applies beyond the use itself, and the exclusion of decks is part of the use, not a separate rule.
- (b) Decks. The recovered PVC has to sit in a middle layer that is fully covered by other material.
- (c) Concealed spaces. The article is not accessible during normal use.
- (d) Interior profiles. The surface layer of the profile contains lead below 0.1 %, while the recovered core may run up to the 1.5 % cap.
- (e) Multilayer pipes not intended for drinking water. The recovered PVC has to sit in the middle layer of the pipe.
- (f) Fittings not intended for drinking water. No condition applies beyond the use itself.
One design logic runs through all six. Lead-bearing recyclate is allowed only where it is not touched and not in contact with drinking water, which is why four of the six require either a covering layer, a concealed position or a non-potable application, and why the two pipe-side uses are both written as "not intended for drinking water".
A derogated use is a legal permission, not a formulation. The compounding question that follows, how a lead-bearing rigid stream is restabilized, how the phthalate legacy that travels with the same material is handled, and what the derogation means for recyclate pricing, belongs to recycled PVC, where the formulation side of the derogated stream is covered in full.
The closed-loop condition that applies from 28 May 2026#
Since 28 May 2026, recovered rigid PVC that comes from the derogated categories (a) to (d) may be used only to make new articles in those same categories, which turns the profile and sheet stream into a closed loop. The condition attaches to the origin of the material, not to its lead content.
Operationally, the recycler has to know which derogated category a bale came from and keep that stream separate through sorting, grinding and compounding, because a profile regrind can no longer be sold into a pipe or a fitting application. Categories (e) and (f), the multilayer non-drinking-water pipes and the non-drinking-water fittings, are not channelled in the same way, as Table T3 records. The rule is a channelling obligation on where derogated material may go, not a recycled-content target and not a quota.
Why the recovered flexible PVC derogation ended on 28 May 2025#
The derogation for articles containing recovered flexible PVC ended on 28 May 2025, so every flexible PVC article placed on the European Union market now has to meet the 0.1 % limit in full, whatever its recycled content. The Official Journal text set no lead concentration cap for this derogation while it ran, and none may be assumed from the rigid figure.
Soft PVC streams that carry legacy lead, such as old flooring and cable compound, therefore have no lawful route into new flexible articles in the European Union above the general limit. The flexible recyclate question has become a sorting and dilution question rather than a derogation question, which is a harder problem than it sounds, because the lead in a 1990s cable compound is distributed through the material and not concentrated in a layer that can be removed.
Marking and documentary evidence for derogated recovered PVC#
Every article placed on the market under the recovered rigid PVC derogation carries the marking Contains ≥ 0,1 % lead, reproduced with the comma decimal separator used in the Official Journal. The wording is fixed by the entry and is not a paraphrase that a supplier may reformulate into "contains lead" or "0.1 % Pb". The evidence set that sits behind the marking has four parts.
- The marking on the article or its packaging, in the exact Official Journal wording
- Documentary evidence that the PVC is recovered rigid PVC
- A statement of the derogated category the article falls into, because the closed-loop rule since 28 May 2026 depends on it
- The supplier declaration and the safety data sheets for the compound
Our verified data set holds the string and the duty, and nothing about format: entry 63 gives no font size, no placement rule, no durability test and no certification scheme for the marking, so this reference prescribes none and names no certification body.
Which Lead-Based Plastic Additives Does Entry 63 Remove from PVC?#
Entry 63 removes three groups of lead-based plastic additives from new European PVC: the basic lead salts used as primary heat stabilizers, the lead soaps that worked as combined stabilizer and lubricant, and the lead chromate pigments. Seven lead entities sit behind those three groups in the Candidate List record, six compounds and the metal itself.
The function those compounds performed is specific. PVC releases hydrogen chloride from 100 to 120 °C, a basic lead salt binds it, and the lead chloride formed is only weakly Lewis-acidic, so the degradation does not turn autocatalytic the way a zinc chloride burn does. The trade-offs were a weaker early colour than a tin stabilizer, because labile-chlorine substitution by lead is weak, and very good electrical properties in cable insulation, which is why lead stabilizers persisted longest in wire and cable. The mechanism, the six compounds and the lead-free comparison are set out on lead stabilizers.
Levels are given here only as the sourced ranges. Lead for heat stabilization is generally 0.05 to 5 wt% of the PVC, the range reported by Wiesinger and co-workers in 2024, and the archived ECHA plastic additives mapping exercise gives about 2 wt% as the typical content of tetrabasic lead sulfate in soft and rigid PVC. No phr value for a lead compound is in our verified data set, so none appears on this page.
Table T4: The lead compounds entry 63 reaches
| Compound | CAS | EC | Function in PVC | Candidate List | Recommended for Annex XIV on 21 Oct 2019 | Substance page |
|---|---|---|---|---|---|---|
| Tribasic lead sulfate (TBLS) | 12202-17-4 | 235-380-9 | primary heat stabilizer, HCl scavenger | 19 Dec 2012, Art. 57(c) | no | tribasic lead sulfate |
| Tetrabasic lead sulfate | 12065-90-6 | 235-067-7 | heat stabilizer, legacy | 19 Dec 2012, Art. 57(c) | no | tetrabasic lead sulfate |
| Dibasic lead phosphite (DBLP) | 12141-20-7 | 235-252-2 | primary heat stabilizer with phosphite antioxidant function | 19 Dec 2012, Art. 57(c) | yes | dibasic lead phosphite |
| Dibasic lead stearate (DBLS) | 12578-12-0 | 235-702-8 | lead soap, stabilizer plus lubricant | 19 Dec 2012, Art. 57(c) | yes | lead stearate and dibasic lead stearate |
| Fatty acids, C16-18, lead salts | 91031-62-8 | 292-966-7 | lead soap | 19 Dec 2012, Art. 57(c) | yes | covered there |
| Dibasic lead phthalate | 69011-06-9 | 273-688-5 | heat-resistant PVC cable, legacy | 19 Dec 2012, Art. 57(c) | yes | no own page; covered on the lead stabilizers page |
| Lead (metal) | 7439-92-1 | 231-100-4 | not an additive; the element the entry measures | 27 Jun 2018, Art. 57(c) | not applicable | no own page |
(1) Neutral lead distearate (CAS 1072-35-1, EC 214-005-2) is not individually on the Candidate List; the listed entry is fatty acids, C16-18, lead salts. (2) The ECHA recommendation of 21 October 2019 covered seven lead compounds but not tribasic or tetrabasic lead sulfate, and none of them was added to Annex XIV.
Each compound's identity, hazard classification and regulatory matrix sits in the plastic additives database.
How Do You Show That a PVC Compound Complies with Entry 63? 7 Steps#
Show compliance in 7 steps: list the lead-bearing ingredients, decide which instrument owns the article, define the reference material, convert every dosage to one basis, separate any recovered PVC fraction, collect the evidence, and set the re-check dates. Entry 63 sets the limit; the sequence below is this reference's recommended way to prove it.
- List every lead-bearing ingredient in the formulation by CAS number, including the stabilizer one-pack, the pigments, the filler and any recovered PVC fraction, because entry 63 counts elemental lead from all of them.
- Decide which instrument owns the article first: food contact materials, electrical and electronic equipment, packaging and toys are outside entry 63 and carry their own lead limits.
- Define the reference material as the PVC material of the article, assessed per component and, where the entry distinguishes layers, per layer.
- Convert every dosage to the same basis, using wt% equal to the phr of the ingredient divided by the total phr of the formulation and multiplied by 100, then sum the elemental lead contributed by each lead-bearing ingredient from its molecular formula and molar mass.
- Separate any recovered PVC fraction and test it against the derogation list, its 1.5 % cap, the closed-loop channelling since 28 May 2026 and the end date of 28 May 2033.
- Collect the evidence: a supplier declaration naming entry 63, the safety data sheets, documentary evidence of recovered origin, the marking artwork where the derogation applies, and an analytical result for the PVC material.
- Set re-check dates for 28 May 2028 and 28 May 2033, and for the January and June Candidate List update windows, because the same material is also assessed against the Candidate List and Annex XIV.
Step 4 carries no worked numeric example on this page because the elemental lead mass fraction of each compound is not in our verified data set, so the method is given and the arithmetic is left to the formulation, with the molecular formula and molar mass of each compound held on its substance page. The phr to wt% conversion itself, and the calculator that performs it, are documented on our PHR conversion page and in the PHR calculator. Step 6 asks what must be proven and names no technique, no standard number and no detection limit, because no analytical method for lead in a plastic material is in this reference's verified data set.
Check one additive against every list at once with the additive regulatory status checker.
Which Other Rules Cap Lead in a PVC Article?#
Entry 63 is one of 7 EU rules that cap lead in an article containing PVC, and the one that applies depends on what the article is: a window profile is judged by entry 63, a cable in a laptop by RoHS, a blister pack by the packaging and food-contact rules, and a toy by the toy rules. The comparison matters because the four excluded article groups of entry 63 are exactly the groups where another instrument takes over, each with its own reference material and its own date.
Table T5: The instruments that cap lead in an article containing PVC
| Instrument | What it limits | Limit | Reference material or scope | Applies from | Read more |
|---|---|---|---|---|---|
| REACH Annex XVII entry 63 (Reg. (EU) 2023/923) | lead and its compounds in PVC articles | at or above 0.1 % prohibited | the PVC material | 29 Nov 2024 | this page |
| REACH Annex XVII entry 23 (Reg. (EU) No 494/2011) | cadmium in listed plastics, including PVC | below 0.01 % Cd; recovered rigid PVC up to 0.1 % in listed building uses | the plastic material | 10 Dec 2011 | REACH Annex XVII restrictions (linked below) |
| RoHS, Directive 2011/65/EU | lead in electrical and electronic equipment | 0.1 % Pb (cadmium 0.01 %) | each homogeneous material | in force | RoHS and plastic additives |
| PPWR, Regulation (EU) 2025/40 | lead, cadmium, mercury and hexavalent chromium in packaging | 100 mg/kg as the sum of the four | packaging and packaging components | 12 Aug 2026 | EU Packaging and Packaging Waste Regulation (PPWR) |
| Regulation (EU) No 10/2011, Annex II | lead migrating from plastic food contact materials | not detectable | migration into food or simulant | in force | EU 10/2011 |
| Toy Safety Regulation (EU) 2025/2509 | substances with a harmonised CMR classification in toys | prohibition of CMR 1A, 1B and 2 substances | toy materials | 1 Aug 2030 (repealing Directive 2009/48/EC) | EU Toy Safety Regulation |
| Drinking-water contact rules | additives and materials in contact with drinking water | positive lists and national schemes | the product in contact with drinking water | in force | plastic additives in drinking-water contact |
| Recycled plastics rules | recycled plastic for food contact and recycled content | see the instrument | per instrument | per instrument | recycled plastics regulations |
Entry 63 does not apply to the article groups covered by the instruments in rows 3 to 6; see the exclusion list above. Row 2 is listed as the cadmium parallel to entry 63, with the same recovered-rigid-PVC construction, and not as a lead limit. Verified 25 September 2026.
Where entry 63 sits in REACH Annex XVII and the wider plastic additive regulations#
Entry 63 is one of the restrictions in Annex XVII to Regulation (EC) No 1907/2006 that reach a substance a compounder adds to a plastic, and it is the only one written specifically around PVC. Annex XVII entries are numbered up to 83, and the other entries that touch a plastic compound, from organotins in entry 20 to PFHxA in entry 79, are indexed on REACH Annex XVII restrictions.
A restriction is not the only REACH instrument that reaches an additive, and the three differ in what they oblige. A restriction bans a use outright at a stated limit, Candidate List inclusion creates information duties, and Annex XIV creates an authorisation requirement for the listed use. The Candidate List holds 253 entries as of its last update on 4 February 2026 and Annex XIV holds 59, so the restriction route touches a far smaller set of substances than the information route.
Lead in PVC is one case inside a much larger body of plastic additive regulations. Every instrument that governs an additive, from food contact to persistent organic pollutants, is mapped in plastic additive regulations, which is the entry point when the question is which rule owns a given article rather than how entry 63 reads.
RoHS, PPWR, food-contact and drinking-water limits on lead#
RoHS sets the strictest geometric basis of the four: 0.1 % lead in each homogeneous material of electrical and electronic equipment under Directive 2011/65/EU, which is a smaller unit than the PVC material of entry 63 and therefore a harder test for a thin PVC cable sheath. The RoHS cadmium limit on the same basis is 0.01 %. RoHS does not ban lead in PVC as such: it applies to equipment, entry 63 applies to PVC articles, and the exclusion of electrical and electronic equipment from entry 63 keeps the two apart.
Packaging and food contact split into a composition limit and a migration limit, which are two different kinds of value. The Packaging and Packaging Waste Regulation, Regulation (EU) 2025/40, caps lead, cadmium, mercury and hexavalent chromium at 100 mg/kg as the sum of the four in packaging and packaging components, applying from 12 August 2026, and it is the sum that is capped rather than any single metal. Food-contact plastics are governed instead by Annex II to Regulation (EU) No 10/2011, under which lead must not be detectable in migration into food or a food simulant.
Toys and drinking water complete the set. The Toy Safety Regulation (EU) 2025/2509 applies from 1 August 2030, repealing Directive 2009/48/EC, and prohibits substances with a harmonised CMR classification in categories 1A, 1B and 2 in toy materials. Drinking-water contact is governed by positive lists and national schemes rather than by one concentration figure, which is why two of the six entry 63 derogations, the multilayer pipes and the fittings, exclude drinking-water applications by their own wording.
SVHC listing, Annex XIV and why REACH restricted lead in PVC instead of authorising it#
Lead in PVC ended up as a restriction rather than an authorisation: the six lead stabilizer substances went onto the Candidate List on 19 December 2012 as toxic for reproduction under Article 57(c), ECHA recommended seven lead compounds for the Authorisation List on 21 October 2019, none of them was added, and the Commission closed the gap with entry 63 instead. Lead metal itself followed onto the Candidate List on 27 June 2018, and every plastic additive on the SVHC Candidate List is listed there with its inclusion date.
The distinction still matters after the restriction, because the Candidate List duties run on their own basis and are not switched off by entry 63. An article with a component containing a listed lead compound above 0.1 % w/w still triggers communication to recipients under Article 33, with consumer requests answered within 45 days, notification to ECHA under Article 7(2) above 0.1 % w/w and above one tonne a year per actor within six months of inclusion, and an entry in the SCIP database, which has been running since 5 January 2021. Each component is assessed on its own under the "once an article, always an article" principle established by the Court of Justice in case C-106/14 of 10 September 2015.
The authorisation route was available and was not used. The lead compounds were recommended for Annex XIV on 21 October 2019 and never added, so none of them is on the Authorisation List and no sunset date applies to them. The substances that did reach the REACH Annex XIV Authorisation List, with their sunset dates, are listed separately.
What applies in the United States: Proposition 65 lead listings#
In the United States, lead and lead compounds are listed under California Proposition 65, for cancer since 1 October 1992 and, for lead, with a developmental and reproductive endpoint since 27 February 1987, on the OEHHA list edition of 31 July 2026. A Proposition 65 listing creates a warning duty rather than a concentration limit, which makes it a different kind of instrument from entry 63.
Lead-stabilized PVC also remains a live import question rather than a closed chapter. Lead stabilizers still held 25.1 % of the global PVC heat stabilizer market in 2023 against about 50 % for calcium-based systems and 15.4 % for tin, on a market-research split for that year, so an EU buyer sourcing PVC articles outside Europe is buying from a market where lead systems are still in production. The warning duty and the safe-harbor levels are set out on California Proposition 65.
What Replaces Lead Stabilizers in PVC? Calcium-Zinc, Organotin and Organic Systems#
Three systems replace lead in PVC: calcium-zinc, calcium-organic and organic-based packages, which together make up 83 % of European PVC stabilizer use on VinylPlus figures from June 2023, and organotin, which dominates rigid PVC in North America. No commercial one-pack is recommended here and no supplier brand is named, because this page is supplier-neutral.
Table T6: Lead-free replacement routes
| System | Chemistry | Typical PVC uses | Level in the formulation | Node page |
|---|---|---|---|---|
| Calcium-zinc | calcium and zinc soaps with co-stabilizers | rigid pipe, profile, sheet, flexible film and flooring | total stabilizer 1 to 5 % of the formulation | calcium-zinc stabilizers |
| Organotin | methyltin and other organotin mercaptides | rigid PVC, standard in North American pipe | methyltin 0.3 to 1.0 phr in US pressure pipe | organotin stabilizers |
| Co-stabilizers and organic-based packages | polyols, beta-diketones, hydrotalcite, aminouracil and other heavy-metal-free components | the long-term component of lead-free pipe, profile and cable packages | part of the same 1 to 5 % total | PVC co-stabilizers |
Calcium-zinc and calcium-organic systems together account for 83 % of EU PVC stabilizer use (VinylPlus, June 2023). Dosage figures are the sourced values in this reference's data set; no figure is a supplier recommendation.
The European switch was finished long before the law required it. ESPA records EU-15 lead stabilizer consumption falling from 127,156 tonnes in 2000 to 30,708 tonnes in 2010, with calcium-based stabilizers rising by 29,472 tonnes between 2007 and 2014 across the EU-27 plus Norway, Switzerland and Turkey, and the voluntary replacement by ESPA members was complete by the end of 2015, nine years before entry 63 applied. The full comparison of calcium-zinc, tin and organic systems, with dosage ranges, sits on PVC heat stabilizers.
One consequence a reformulator feels is physical rather than regulatory. The total stabilizer level stays in the 1 to 5 % band on ECVM figures whichever route is chosen, so the switch is not a dosage jump, but a calcium-based stabilized dry blend runs about 2 % lower in density than the lead-stabilized blend it replaces, a figure claimed by the supplier Baerlocher, which shifts gravimetric dosing and output calculations on an existing line. The rest of the package, from the lubricant to the impact modifier, is set out in additives for PVC.
Is Lead-Stabilized PVC Still a Problem in Buildings and Recyclate?#
Lead-stabilized PVC is still a live issue in two places: the installed stock of windows, pipes and cables built before the restriction, and the recyclate that comes back from it, where 16 % of 151 new PVC floorings on the Swiss market were found to contain regulated chemicals above 0.1 wt%, mainly lead and DEHP. Marie Wiesinger, Zhanyun Wang and Stefanie Hellweg at ETH Zürich tested those 151 new PVC floorings and reported the result in Environmental Science and Technology in 2024, attributing the lead and DEHP content to recycled PVC.
What the classification record supports is a statement about hazard, not about exposure. The lead stabilizers carry reproductive-toxicity classifications, tribasic lead sulfate as Repr. 1A with H360Df and H372 or H373, which is the Article 57(c) ground on which the six substances were listed in 2012, and the control mechanism the European Union chose is the restriction with its derogation conditions rather than a consumer precaution. Lead is one of four legacy additives in recycled plastic, alongside brominated flame retardants, cadmium and phthalates, that a recycler has to design around.
How much lead is still found in new PVC products#
In the most detailed survey available, 16 % of 151 new PVC floorings sampled on the Swiss market contained regulated substances above 0.1 wt%, mainly lead and DEHP, which the authors attributed to recycled PVC. A further 29 % of the same 151 samples contained other ortho-phthalates above 0.1 wt%.
The detection pattern in the same 151 samples shows that the stabilizer switch has happened: zinc was detected in 96 %, barium in 72 % and tin in 58 %, which is the signature of calcium-zinc, barium-zinc and organotin stabilization rather than lead. The study measured content and not lawfulness, since an article's legal position under entry 63 depends on its date, its use and its derogation status. Lead sits alongside the other restricted substances on toxic plastic additives.
Does PVC pipe contain lead?#
A new PVC pipe placed on the European Union market must contain less than 0.1 % lead in its PVC material, and the only exception is recovered rigid PVC in the middle layer of a multilayer pipe that is not intended for drinking water, allowed until 28 May 2033. Drinking-water pipe has no lead derogation at all under entry 63, by the wording of the six derogated uses.
Pipe is also where the global question sits, because about 75 % of India's roughly 3,700 kilotonnes of PVC consumption in 2021 went into pipes and fittings, on figures published by a supplier in that market. The stabilizer and drinking-water compliance picture for pipe is on additives for PVC pipe.
Is PVC with lead stabilizers safe to touch?#
The lead compounds used as PVC stabilizers are classified as toxic for reproduction, which is the legal ground on which they were listed, and the European restriction works on their content in the article rather than on contact with it. This reference states classifications and legal limits and does not quantify dermal exposure from a finished article, because no such value is in its verified data set.
What the Commission must review by 28 May 2028#
Entry 63 obliges the Commission to review the recovered-PVC derogation by 28 May 2028, five years before it expires, which is the one date on this page where the law could still change. The review can touch the 1.5 % cap, the six derogated uses, the closed-loop channelling of categories (a) to (d) and the 2033 end date, and the battery-separator exemption runs to that same 2033 date.
A review obligation with a deadline is not a forecast, so this page states no expected outcome, in either direction, and reports no stakeholder position.
How this page is updated: regulatory watch and news#
This page is re-checked against the Official Journal and the ECHA lists at every Candidate List update window in January and June, and whenever an amending regulation touches entry 63. Each change is recorded with its date in plastic additives news.