Lead and its compounds in PVC to Annex XVII of Regulation (EC) No 1907/2006 of the European Parliament and Council

Insights:-

The Commission of Europe, regarding the European Union’s Treaty on the Functioning of the Union,

Regulation (EC) No 1907/2006 of the European Parliament and Council of December 18, 2006, regarding the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), creating a European Chemicals Agency, revising Directive 1999/45/EC, annulling Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94, as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC, and 2000/21/EC

At the request of the Commission, the European Chemicals Agency (‘the Agency’) submitted a dossier pursuant to Article 69(1) of Regulation (EC) No 1907/2006 (‘the Annex XV dossier’) on 16 December 2016 showing that lead releases from articles made from polymers or copolymers of vinyl chloride (‘PVC’) containing lead stabilisers contribute directly and indirectly to human lead exposure. The Agency suggested in the Annex XV dossier to restrict the placing on the market or use of lead in articles produced from PVC if the concentration of lead is equal to or greater than 0,1 % by weight of the PVC material. 

Since lead compounds cannot stabilize PVC at concentrations below 0.5 % by weight, the proposed concentration limit should prevent the Union from intentionally adding lead compounds as stabilisers during PVC compounding. The Agency also included in the Annex XV dossier a number of derogations to this suggested restriction, notably for PVC articles containing recovered PVC. ‘Recovered’ is used in line with the definition of ‘material recovery’ in Article 3, point 15a, of Directive 2008/98/EC of the European Parliament and of the Council

Lead poisons the neurological system, causes chronic renal disease, and raises blood pressure. Although no threshold for neurodevelopmental effects in children and for renal effects has been established, according to the European Food Safety Agency the current human exposure to lead from food and other sources still exceeds the tolerable exposure levels and leads to adverse neurodevelopmental effects in children

Lead stabilisers improve PVC compounding and article thermal stability. They also protect PVC against photo-degradation. Industry in the Union voluntarily phased out the use of lead stabilisers in PVC compounding and PVC articles and reported that that process was successfully completed in 2015. PVC articles containing lead, especially construction products, have long service lives, remaining in use for periods exceeding several decades, after which they become waste upon disposal and may undergo recycling, potentially re-introducing lead into products via the recovered PVC. The Annex XV dossier showed that 90 % of the estimated total emissions of lead from PVC articles in the Union in the year 2016 was attributable to imported PVC articles, due to the phase-out of lead stabilisers in the union.

To make the proposed restriction easier to enforce, lead in PVC should be limited regardless of its purpose.

In its final opinion, adopted on December 5, 2017, the Agency’s Committee for Risk Assessment (or “RAC”) concluded that, in terms of practicality, monitorability, and effectiveness in reducing the risks associated with lead compounds used as stabilisers in PVC articles, the restriction suggested by the Agency is the most suitable Union-wide measure to address those risks.

RAC suggested outlawing the use of lead in PVC products at any concentration. Additionally, RAC concurred with the Agency that PVC products that incorporate recovered PVC should be exempt. However, RAC suggested setting higher lead content limitations of 2% and 1% by weight, respectively, for specific PVC products that incorporate recovered rigid and flexible PVC. That suggestion took into consideration the assessment that disposing of PVC trash through landfilling and incineration, as an alternative to recycling such articles, would raise environmental emissions rather than lower risk.The various suggested restrictions were based on the calculated average lead content of rigid and flexible PVC waste in 2013, the anticipated effect on recycling volumes, and the fact that flexible PVC is known to release more lead than rigid PVC. The fact that some items include a high percentage of recovered PVC up to 100% by weight of the PVC in the finished article was duly noted.

On 15 March 2018, the Agency’s Committee for Socio-Economic Analysis (‘SEAC’) adopted its final opinion in which it concluded that the restriction proposed by the Agency, as modified by both RAC and SEAC, was the most appropriate Union-wide measure to address the identified risk, in terms of its socioeconomic benefits and socioeconomic costs. SEAC reached that conclusion based on best available evidence, taking into account the properties of lead as a non-threshold toxic substance and its impact on human health, and the affordability of the costs associated with the proposed restriction. SEAC considered that there are suitable alternatives widely available and already used in the Union. It also considered the cost-effectiveness of the restriction. Finally, it concluded that even limited human health impacts in terms of intelligence quotient loss, would be sufficient to break even with the costs of the restriction.

SEAC agreed with the proposal in the Annex XV dossier that, considering the projected evolution of the concentration of lead in recovered PVC, that concentration would decrease sufficiently by 2035 – 2040 to allow PVC articles containing recovered PVC to comply with the proposed general lead concentration limit of 0,1 %. Therefore, the derogation for certain PVC articles containing recovered PVC should apply for 15 years from the entry into force of the restriction. SEAC further agreed that, in order to account for the uncertainty with respect to the future trends regarding the amount of PVC waste going to recycling and its lead content, that period of application should be reassessed within 10 years from the entry into force of the restriction. In line with the aim of the 2015 EU Action Plan for the Circular Economy to promote non-toxic material cycles and preserve the high level of protection for human health and the environment, the Commission considered that that period of application should be reassessed within 7,5 years from the entry into force of the restriction.

The Agency’s Forum for Exchange of Information on Enforcement was consulted on the proposed restriction and its opinion was taken into account, resulting in a modified description of the scope and of the derogations from the proposed restriction.

On 26 April 2018, the Agency submitted the final opinions of RAC and SEAC to the Commission.

Taking into account the Annex XV dossier and the opinions of RAC and SEAC, and considering that there is an unacceptable risk to human health from lead in PVC articles, the Commission proposed a draft Commission regulation restricting the use of any concentration of lead and its compounds in PVC articles and the placing on the market of lead and its compounds in PVC articles in a concentration equal to or greater than 0,1 % by weight of the PVC material (“the draft regulation”). The draft regulation received a favourable opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006 on 20 November 2019.

In accordance with the regulatory procedure with scrutiny referred to in Article 133(4) of Regulation (EC) No 1907/2006, a resolution objecting to the draft regulation was adopted by the European Parliament plenary on 12 February 2020. Consequently, the draft regulation was not adopted by the Commission.

The Parliament requested in its resolution that the Commission eliminate the exceptions for recovered PVC since doing so would result in lead being carried over into new products. Additionally, the Parliament asked that the exception for the two lead pigments covered by the REACH authorization framework be lifted. Additionally, the Commission was requested to remove the proposed marking requirements for PVC products that contain recovered PVC because it believed that they were deceptive and failed to take into account the fact that recovered PVC has a greater lead content than newly produced PVC. Lastly, the Parliament requested that the Commission shorten the suggested transitional period during which the regulation’s provisions will take effect.

The Commission has given the Parliament’s resolution a thorough evaluation and recognizes that some issues need to be addressed. Furthermore, it believes that lead in PVC products continues to pose an intolerable risk to human health, which requires Union-wide action. In light of this, the Commission made the decision to revise a few of the draft regulation’s clauses in order to take into account pertinent new information obtained from the Agency and interested parties, as well as to reflect the arguments made by the Parliament.

In particular, the Commission considers that clean recycling technologies which allow the removal of legacy substances of concern, including lead, from PVC waste should be encouraged. Current recycling technologies, however, can reduce but not completely eliminate legacy substances. It is therefore necessary to set a concentration limit of 0,1 % of lead by weight not only for the placing on the market but also the use of lead and its compounds in PVC, in order to allow both the placing on the market of articles containing less than 0,1 % of lead by weight of the PVC material and the continued use in articles of PVC material containing lead below that limit, such as PVC material recovered through chemical recycling or solvent dissolution and containing very small amounts of lead.

As a means of limiting the carryover of lead in new products, the derogation for PVC articles containing recovered flexible PVC should be removed from the draft regulation. However, economic operators should be granted a 24-month period to adapt to the new requirements.

However, a derogation for certain PVC articles containing recovered rigid PVC should be laid down to achieve an appropriate balance between the overall long-term benefits from the circular use of those materials and the overall long-term health concerns relating to that recovered material. Following industry reports that the average lead concentration in recovered rigid PVC is below 1,5 % due to routine mixing of pre- and post-consumer waste, the allowed lead concentration limit in recovered rigid PVC should be reduced from 2 % to 1,5 % by weight. To prevent the possible leaching of lead and the formation of lead-containing dust, recovered rigid PVC in derogated articles should be entirely enclosed within a layer of newly produced PVC, recovered PVC or other suitable material that contains less than 0,1 % of lead by weight, unless the derogated article is inaccessible during normal use. In addition, the Commission agrees with the Parliament that the benefits to health protection to be achieved with the restriction should be pursued faster. Consequently, the duration of the derogation should be decreased from 15 to 10 years. A review of the derogation should take place at the latest 5 years after the entry into force of the restriction. The review should include verifying trends regarding lead concentration in recovered PVC, the availability of adequate decontamination techniques and the socioeconomic impact of removing the derogation, considering the risk to human health and to the environment.

To limit the presence of lead from recovered rigid PVC to certain known articles, rigid PVC recovered from profiles and sheets in buildings and civil engineering works and containing more than 0,1 % of lead by weight of the PVC should only be used to produce new PVC profiles and sheets for the same applications. In combination with appropriate marking obligations, this should ensure the identification of lead-containing products and facilitate future decontamination activities. It should also promote a separate collection and recycling of PVC pipes (currently rarely recycled), as pipe producers who currently use PVC recovered from profiles and sheets to produce new pipes will need to replace it with an alternative PVC source. However, in order to allow economic operators sufficient time to put in place dedicated PVC waste collection and recycling, re-organise their supply chains and, where needed, procure recovered PVC from other origin than profiles and sheets, this obligation should apply after 36 months from the entry into force of this Regulation.

For enforcement purposes and to ensure that professionals and consumers are adequately informed of possible risks, PVC articles containing recovered rigid PVC should be marked if they contain lead in a concentration equal or greater than 0,1 % by weight of the PVC material. This should also facilitate the separate collection of lead-containing waste.

Considering the difficulties to determine if PVC in articles is of recovered origin, suppliers of PVC articles benefitting from derogations associated with their content in recovered PVC should be able to prove the recovered origin of the material by presenting documentary evidence. In the Union, several certification schemes, all of which are based on technical specifications in EN 15343:2007, are available to recyclers to support claims on the traceability of recovered PVC. Given the lack of suitable practical means for enforcement authorities to verify recovery claims associated with recovered PVC in imported articles, such claims should be substantiated via independent third party certification.

The specific derogation previously proposed for the lead pigments “lead sulfochromate yellow” and “lead chromate molybdate sulfate red” should be removed from the draft regulation. In view of recent case law and the Agency’s intention to submit a restriction dossier pursuant to Article 69(2) of Regulation (EC) No 1907/2006 related to the risks stemming from the use of those two lead pigments, the Commission considers that that derogation has become unnecessary.

In view of the low risks and the lack of suitable alternatives, a derogation for PVC-silica separators in lead batteries should be set out for a period of 10 years from the entry into force of this Regulation, after which suitable alternatives are expected to be available.

To avoid double regulation, a derogation should be laid down for articles already covered by Regulation (EC) No 1907/2006 or other Union legislation regulating lead content in PVC.

As industry in the Union has not been using lead stabilisers in PVC since 2015, a period of 18 months is considered sufficient for most economic operators to be able to adapt to the new requirements, dispose of their stock and communicate relevant information on the restriction within their supply chains. Furthermore, the restriction should not apply to PVC articles already placed on the market before the end of that period, as that would give rise to considerable enforcement difficulties.

The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006.

Regulation adopted,

Article 1:- Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this Regulation.

Article 2:- This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

In entry 63, column 2, of Annex XVII to Regulation (EC) No 1907/2006, the following paragraphs are added:

15. Shall not be placed on the market or used in articles produced from polymers or copolymers of vinyl chloride (‘PVC’), if the concentration of lead is equal to or greater than 0,1 % by weight of the PVC material.

16. Paragraph 15 shall apply with effect from 29 November 2024.

17. By way of derogation, paragraph 15 shall not apply to PVC articles containing recovered flexible PVC until 28 May 2025.

18. By way of derogation, paragraph 15 shall not apply to the following PVC articles containing recovered rigid PVC until 28 May 2033, if the concentration of lead is lower than 1,5 % by weight of the recovered rigid PVC:

(a)profiles and sheets for exterior applications in buildings and civil engineering works, excluding decks and terraces;

(b)profiles and sheets for decks and terraces, provided that the recovered PVC is used in a middle layer and is entirely covered with a layer of PVC or other material for which the concentration of lead is lower than 0,1 % by weight;

(c)profiles and sheets for use in concealed spaces or voids in buildings and civil engineering works (where they are inaccessible during normal use, excluding maintenance, for example, cable ducts);

(d)profiles and sheets for interior building applications, provided that the entire surface of the profile or sheet facing the occupied areas of a building after installation is produced using PVC or other material for which the concentration of lead is lower than 0,1 % by weight;

(e)multi-layer pipes (excluding pipes for drinking water), provided that the recovered PVC is used in a middle layer and is entirely covered with a layer of PVC or other material for which the concentration of lead is lower than 0,1 % by weight;

(f)fittings, excluding fittings for pipes for drinking water.
From 28 May 2026, rigid PVC recovered from the categories of articles referred to in points (a) to (d) shall only be used for the production of new articles of any of those categories.
Suppliers of PVC articles containing recovered rigid PVC with a concentration of lead equal to or greater than 0,1 % by weight of the PVC material shall ensure, before placing those articles on the market, that they are visibly, legibly and indelibly marked with the statement: “Contains ≥ 0,1 % lead”. Where the marking cannot be provided on the article due to the nature of the article, it shall be on the packaging of the article.
Suppliers of PVC articles containing recovered rigid PVC shall submit to national enforcement authorities upon request documentary evidence to substantiate the claims on the recovered origin of the PVC in those articles. Certificates issued by schemes to provide proof of traceability and recycled content, such as those developed according to EN 15343:2007 or equivalent recognised standards, may be used to substantiate such claims for PVC articles produced in the Union. Claims made on the recovered origin of the PVC in imported articles shall be accompanied by a certificate that provides equivalent proof of traceability and recycled content, issued by an independent third party.
By 28 May 2028, the Commission shall review this paragraph in light of new scientific information and, if appropriate, modify it accordingly.

19. By way of derogation, paragraph 15 shall not apply to:

(a)PVC-silica separators in lead acid batteries, until 28 May 2033;

(b)articles covered by paragraph 1, in accordance with paragraphs 2 to 5, and by paragraph 7 in accordance with paragraphs 8 and 10;

(c)articles within the scope of:

(i)Regulation (EC) No 1935/2004;

(ii)Directive 2011/65/EU;

(iii)Directive 94/62/EC;

(iv)Directive 2009/48/EC.

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