EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  draft  
 
COMMISSION REGULATION (EU) No …/..  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council as regards lead and its compounds in PVC  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) No …/..  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council as regards lead and its compounds in PVC  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the 
Council of 18  December 2006 concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending 
Directive 1999/45/EC and repealing 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/EC1, and in particular Article 
68(1) thereof,  
Whereas:  
(1) On 16 December 2016 , the European Chemicals Agency (‘the Agency’) submitted , at 
the request of the Commiss ion, a dossier2 pursuant to Article 69( 1) of Regulation (EC) 
No 1907/2006  (‘the Annex XV dossier’) , demonstrat ing that releases of lead  from 
articles produced from polymers or copolymers of vinyl chloride ( ‘PVC ’) containing  
lead stabilisers, during their life -cycle, contribute directly and indirectly to human 
exposure to lead. 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 o f lead is equal to or greater than 0,1 % by weight of the PVC material . 
Considering that lead compounds cannot stabilise PVC in an effective way at 
concentrations below approximately 0,5  % by weight, the concentration limit proposed 
should ensure that the intentional addition of lead compounds as stabilisers during 
PVC compounding can no longer occur in the Union. 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 Council3.     
(2) Lead is a toxic substance which affects the development of the nervous s ystem, 
produces chronic kidney disease and has adverse effects on blood pressure. A lthough 
no threshold for neurodevelopmental effects in children and for renal effects has been 
established , according to the European Food Safety Agency  the current human 
                                                 
1 OJ L 396, 30.12.2006, p . 1. 
2 https://echa.europa.eu/documents/10162/e70aee23 -157b -b2a4 -2cae-c42a1278072c  (report);  
https://echa.europa.eu/documents/10162/cc1c37a8 -22f9-7a7a -cb33 -5c29edba7094  (annex)  
3 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste 
and repealing certain Directives  (OJ L 312 22.11.2008, p. 3) . EN 2  EN exposure to lead from food and other sources still exceeds the tolerable exposure 
levels and leads to adverse neurodevelopmental effects in children4.  
(3) Lead stabilisers increase the thermal stability of PVC  during compounding and article 
production . 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 th at process was successfully completed in 20155. PVC 
articles containing lead, espec ially construction products, have long service lives, 
remaining in use for periods exceeding several decades, after which they become 
waste upon disposal and may undergo  recycl ing, 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 . 
(4) To facilitate the enforcement of the  proposed restriction, it is appropriate to restrict  
any lead present in PVC regardless of its intended function    
(5) On 5 December  2017, the Agency’s Committee for Risk Assessment (‘RAC’) adopted 
its final opinion6, concluding that the restriction proposed by the Agency  is the most 
appropriate Union -wide measure to address  the identified risks posed by lead 
compounds present as stabilisers in PVC articles  in terms of effectiveness in reducing  
such risks , practicality and monitorability .  
(6) RAC proposed to comp letely ban the use of lead in PVC articles . RAC  also agreed 
with the Agency that a derogation should be laid down for PVC articles containing 
recovered PVC. RAC however proposed that higher lead content limits for certain 
PVC articles containing recovered rigid and flexible PVC should be established, 
respectively, at 2  % and 1  % by weight. That proposal took account of the estimation 
that the alternative to recycling such articles, i.e. disposal of PVC waste via landfilling 
and incineration, would increase the emissions to the environment and not reduce the 
risk. The different limits proposed took into account the estimated average lead 
content of rigid and flexible PVC waste in 2013, the expected impact on recycling 
volumes and the fact that the release of lead from flexible PVC is known to be higher 
compared to the one from rigid PVC. Due account was taken of the fact that some 
articles have a high content of recovered PVC that may reach 100 % by weight of the 
PVC in the final article.  
(7) On 15 March 2018 , the Agency’s Committee for Socio -Economic Analysis (‘SEAC’) 
adopted its final opinion7 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 identif ied risk, in terms of its socioeconomic benefits and 
socioeconomic costs. SEAC reached th at 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 a ffordability of the costs associated with the 
proposed restriction . SEAC considered  that there are suitable alternatives  widely 
                                                 
4 EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on Lead in Food. 
EFSA Journal 2010; 8(4):1570.      
5 VinylPlus progress report of 201 7, p. 14; see  
https://vinylplus.eu/uploads/downloads/VinylPlus_Progress_Report_2017.pdf .  
6 https://echa.europa.eu/documents/10162/86b00b9e -2852 -d8d4 -5fd7-be1e747ad7fa . 
7  https://echa.europa.eu/documents/10162/86b00b9e -2852 -d8d4 -5fd7-be1e747ad7fa  EN 3  EN 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 .  
(8) SEAC agreed  with the proposal in the Annex XV dossier that, considering the 
projected evolution of the concentration of lead in recovered PVC, th at 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 article s 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 regardin g 
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 Economy8 
to promote non -toxic material cycles and preserve the high level of protection for 
human health and the environment, the Commission consider ed that that period of 
application should be reassessed within 7.5 years  from the entry into force of the 
restricti on. 
(9) 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 .  
(10) On 26 April 2018 , the Agency submitted the  final opinions of RAC and SEAC  to the 
Commission .  
(11) 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 
and placing on the market of lead and its compounds in PVC articles  (“the draft 
regulation”) . The draft regulation  received a favourable opinion of the Committee 
establishe d under Article 133 of Regulation (EC) No 1907/2006 on 20 November 
2019 .  
(12) 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 20209. Consequently , the 
draft regulation  was not adopted by the Commission.  
(13) In its resolution, the Parliament asked the Commission  to remove the derogation s for 
recovered  PVC , as it would lead  to the carry -over of lead into new products. The 
Parliament  also reques ted the removal of the derogation for the two lead pigments 
subject to the authorisation regime under REACH . Furthermore, the Commission was 
asked to delete  the proposed marking requir ements for PVC articles containing 
recovered PVC  as it considered it misleading and not reflecting  that recovered PVC  
                                                 
8 Communication from the Commission to the European Parliament, the Council, the European 
Economic and Social Committee and the Committee of the Regions. Closing The Loop - An EU A ction 
Plan for the Circular Economy. COM/2015/0614 final.  
9  European Parliament resolution of 12 February 2020 on the draft Commission regulation amending 
Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the 
Regi stration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards lead and its 
compounds ( OJ C 294, 23.7.2021, p. 2).  EN 4  EN contains higher amounts of lead than newly produced  PVC . Finally, the  Parliament  
asked the Commission to reduce the proposed transitional period for when the 
provisions of the regulation shall apply . 
(14) The Commission has carefully assessed the resolution of the Parliament  and 
acknowledges the need to address certain  concerns. In addition, it considers that there 
is still an unacceptable risk to human health from lead in PVC articles, which needs to 
be addressed on a Union -wide basis. Against this background , the Commission 
decided  to amend  some  of the provisions  of the draft regulation  to reflect the 
arguments brought forward by the Parliament and take into account relevant new data 
received from the Agency and stakeholders . 
(15) 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 . 
(16) However, a derogation for 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 or other suitable 
material , unless the derogated article is inaccessible during normal use . In addition, t he 
Commission agrees with the Parliament that the benefits to health protection to be 
achieved with  the restriction should be pursued faster. Consequently, t he 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 verify ing trend s regarding  lead concentration in recovered PVC , 
the availability of adequate decontamination techniques and the socio -economic 
impact  of removing the derogation , considering  the risk to human health  and to the 
environment .  
(17) 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 
contain ing 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 provision should also ensure the identification  of 
lead-containing products and facilitate future decontamination activities.  
(18) 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 above 0,1  % by weight  of the 
PVC . This s hould also facilitate the separate collection of lead -containing waste.  
(19) Considering the difficulties to determine if PVC in articles is of recovered origin, 
suppliers of PVC articles benefitting from derogations associated to their content in 
recovered PV C should be able to prove the recovered origin of the material by 
presenting documentary evidence. In the Union, several certification schemes , all of EN 5  EN which are based on technical specifications  in EN 15343:200710, are available to 
recyclers to support clai ms on the traceability of recovered PVC. Given the lack of 
suitable practical means for enforcement authorities to verify recovery claims 
associated to recovered PVC  in imported articles, such claims should be substantiated 
via independent third party cert ification.    
(20) 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 law11 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 . 
(21) A derogation for PVC -silica separators in lead batteries should be  set out, in view of 
the low risks and the lack of suitable alternatives. According to information submitted 
by producers of those PVC separators, suitable alternatives will be available in 
approximately 10 years  from the entry into force of the restriction.   
(22) 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.  
(23) Economic operators should be granted a period of 24 months in order to be able to 
adapt to the new requirements, dispose of their stock and communicate relevant 
information on the restriction within the ir 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.  
(24) Regulation (EC) No 1907/2006 should th erefore be amended accordingly.  
(25) 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 , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance wit h the Annex to 
this Regulation.  
Article  2 
This Re gulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
                                                 
10 Standard EN 15343:2007 on Plastics - Recycled Plastics - Plastics recycling traceability and assessment 
of conformity and recycled content, approved by the European Committee for Standardization on 
2 November 2007 . 
11  European Commission v Kingdom of Sweden , Case C -389/19 P, ECLI:EU:C:2021:131.  EN 6  EN Done at Brussels,  
 For the  Commission  
 The President  
 Ursula von der Leyen