On May 8, 2023, the Official Journal of the European Union L123 published (EU) 2023 923 to amend Annex XVII of the REACH Regulation (1907 2006 EC) on lead and its compounds in PVC, which came into effect on the 20th after the official gazette.
1) On 16 December 2016, the European Chemicals Agency ("the Agency") submitted, at the request of the Commission, a document ("Annex XV Document") pursuant to Article 69(1) of Regulation (EC) No 1907 2006 demonstrating that articles produced by vinyl chloride polymers or copolymers ("PVCs") containing lead stabilizers directly or indirectly cause human exposure to lead during their life cycles. In the Appendix XV file, the agency recommends that if the lead concentration is equal to or greater than 01%, which restricts the release or use of lead in articles produced by PVC. Considering that the lead compound is about 0 by weightPVC cannot be effectively stabilized at concentrations of 5%, and the proposed concentration limit should ensure that the deliberate addition of lead compounds as stabilizers during PVC compounding does not occur in the EU in the EU. It has also included in the Annex XV file a number of derogations from this recommended limitation, in particular for PVC articles containing **PVC. The use of "*" falls within the meaning of "material**" within the meaning of Article 3(15a) of Article 3 of Directive 2008 98 EC of the European Parliament and of the Council.
2) Lead is a toxic substance that affects the development of the nervous system, causes chronic kidney disease, and adversely affects blood pressure. Although no thresholds have been established for neurodevelopmental and renal effects in children, according to the European Food Safety Agency, current human exposure to lead from food and other ** levels still exceeds tolerable exposure levels and leads to neurodevelopmental dysplasia in children.
3) Lead stabilizers increase the thermal stability of PVC in compounding and product production. They also prevent PVC photodegradation. The EU industry voluntarily phased out the use of lead stabilizers in PVC composites and PVC products, reporting that the process was successfully completed in 2015. PVC products containing lead, especially construction products, have a long lifespan and a lifespan of more than a few decades, after which they become waste at the time of disposal and may be carried out, possibly by reintroducing lead into the product through PVC. Annex XV dossier shows that 90% of the total estimated emissions of lead from PVC products in the EU in 2016 were attributable to imported PVC products as a result of the EU's phase-out of lead stabilizers.
4) To facilitate the enforcement of the proposed limit, it is appropriate to limit any lead present in PVC, regardless of its intended function.
5) On December 5, 2017, the agency's Risk Assessment Committee (RAC) adopted a final opinion, concluding that the agency's proposed restriction is the most appropriate Union-wide measure to address the risks posed by lead compounds present as stabilizers in PVC products, effective in reducing such risks, practicality and monitorability.
6) RAC proposes to prohibit the use of lead in PVC products at any concentration. RAC also agrees with the IAEA that derogations should be imposed on PVC articles containing ** polyvinyl chloride. However, RAC recommends that higher lead content limits of 2% and 1% by weight should be set for certain PVC products containing rigid PVC and flexible PVC, respectively. The proposal takes into account an estimate that an alternative to such items, i.e., the disposal of PVC waste through landfilling and incineration, would increase emissions to the environment without reducing the risk. The different limits proposed take into account the estimated average lead content of hard PVC and soft PVC waste in 2013, the expected impact on ** amounts, and the fact that soft PVC is known to release more lead than hard PVC. The fact that the weight of PVC in the final item may reach 100% is duly taken into account, considering the high content of **PVC in some items.
7) On 15 March 2018, the IAEA's Committee for Socio-Economic Analysis ("SEAC") adopted its Final Opinion, which concluded that the IAEA's proposed restrictions, modified by RAC and SEAC, are the most appropriate Union-wide measures to address the identified risks in terms of their socio-economic benefits and socio-economic costs. SEAC has reached this conclusion based on the best available evidence, taking into account the properties of lead as a non-threshold toxic substance and its effects on human health, as well as the affordability of the costs associated with the proposed limits. SEAC believes that there are appropriate alternatives that are widely available and already in use within the Alliance. The Committee also considered the cost-effectiveness of this restriction. Finally, it concludes that even the limited impact on human health in terms of IQ loss is enough to offset the cost of the restrictions.
8) SEAC agrees with the recommendation in the Annex XV dossier that the concentration of lead in PVC will be reduced sufficiently between 2035 – 2040 to allow PVC products containing **PVC to comply with the proposed general lead concentration limit 01%。Therefore, the derogation from certain PVC articles containing **PVC should be applied for 15 years after the restriction takes effect. SEAC further agreed that the applicable period should be reassessed within 10 years of the entry into force of the restriction in order to take into account uncertainty about the future trend of the amount of PVC waste used for ** and its lead content. In line with the objectives of the 2015 EU Action Plan for the Circular Economy to promote the recycling of non-toxic materials and maintain a high level of protection for human health and the environment, the Commission considers that the restriction should be 7The applicable period will be reassessed within 5 years.
9)The IAEA Enforcement Information Exchange Forum was consulted on the proposed restriction and the comments of the Forum were taken into account, resulting in a revised description of the scope and derogation of the proposed restriction.
10) On 26 April 2018, the IAEA submitted its final observations to the Committee on RAC and SEAC.
11) Taking into account the Annex XV dossier and the opinions of the RAC and SEAC, and taking into account the fact that there is an unacceptable risk to human health from lead in PVC articles, the European Commission has proposed a draft Commission to regulate the use of any concentration of lead and its compounds in PVC articles and placed in PVC articles on the market in which the concentration of lead and its compounds is equal to or greater than 0,1% by weight of PVC materials (the "Bill"). The draft regulation was approved by the Committee established pursuant to Article 133 of Regulation (EC) No 1907 2006 on 20 November 2019.
12) In accordance with the regulatory review procedure referred to in Article 133(4) of Regulation (EC) No 1907 2006, the Plenary Session of the European Parliament adopted a resolution against the draft Regulation on 12 February 2020. As a result, the European Commission did not adopt the draft regulation.
13) In its resolution, the parliament asked the committee to remove the derogation from **PVC, as this would lead to the transfer of lead to new products. Parliament also called for the removal of derogations from two lead pigments under the REACH authorisation system. In addition, the Committee was asked to remove the proposed marking requirement for PVC articles containing PVC because it considered it to be misleading and did not reflect a higher lead content of PVC than newly produced PVC. Finally, the Parliament requested the Commission to shorten the proposed transition period in order to apply the provisions of the Regulations.
14) The Committee carefully assessed the resolution of Parliament and recognized the need to address certain concerns. In addition, it believed that lead in PVC products posed an unacceptable risk to human health and needed to be addressed across the Union. In this context, the Commission decided to amend some provisions of the draft statute to reflect the arguments put forward by the Parliament and to take into account the relevant new data received from institutions and stakeholders.
15)In particular, the Committee was of the view that clean** technologies that could remove residues of concern, including lead, from PVC wastes should be encouraged. However, current technologies can reduce, but not completely eliminate, the remnants. Therefore, it is necessary to set 0 not only for products placed on the market, but also for the use of lead and its compounds in PVCA 1% lead concentration limit by weight in order to allow PVC materials placed on the market to contain less than 0 lead1% of items, as well as allowing continued use in PVC materials containing lead below this limit. For example, PVC materials that are chemically or solvent-dissolved, which contain very small amounts of lead.
16) As a means of limiting lead residues in new products, the derogation of PVC products containing ** flexible PVC should be removed from the draft regulations. However, economic operators should have 24 months to adapt to the new requirements.
17) However, for certain PVC articles containing ** hard PVC, a derogation provision should be provided to strike an appropriate balance between the overall long-term benefits of recycling these materials and the overall long-term health problems associated with that ** material. According to industry reports, the average lead concentration in hard PVC is less than 1 due to the conventional mixing of pre- and post-consumer waste5%, so the allowable lead concentration limit in rigid PVC should be reduced from 2% by weight to 15%。To prevent the possible leaching of lead and the formation of lead-containing dust, the hard PVC in the derogatory article should be completely encased in newly produced PVC, PVC or other suitable materials with a lead content of less than 0 by weight, except for derogatory items that cannot be accessed during normal use1%。In addition, the Committee agrees with Parliament that the health protection benefits of restrictive measures should be realized more quickly. Accordingly, the period of derogation should be reduced from 15 to 10 years. The review of the derogation shall take place no later than five years after the entry into force of the limitation. The review should include verification of trends in lead concentrations in PVC, the availability of appropriate decontamination technologies and the socio-economic impact of the cancellation of impairments, taking into account risks to human health and the environment.
18) In order to limit the presence of lead extracted from hard PVC in certain known items, hard PVC from profiles and plates of buildings and civil works if the lead content exceeds 0 by weight of PVC1%, it can only be used to produce new PVC profiles and panels for the same purpose. Combined with appropriate marking obligations, this should ensure the identification of lead-containing products and facilitate future decontamination activities. It should also promote separate collection and **PVC pipes (which are very few at the moment**), because pipe producers who currently use PVC from profiles and plates to produce new pipes will need to replace it with another PVC**. However, in order to allow economic operators sufficient time to establish specialized PVC waste collection and procurement, if required, from other **procurement** of PVC other than profiles and sheets, this obligation shall be implemented 36 months after the entry into force of this regulation.
19) For law enforcement purposes, as well as to ensure that professionals and consumers are fully aware of the possible risks, PVC articles containing ** hard PVC if their lead content is equal to or greater than 0 percent of the weight of the PVC material1%, it should be marked. This will also facilitate the separate collection of lead-containing waste.
20) Considering that it is difficult to determine whether the PVC in the article comes from the country of origin, the PVC article that benefits from the reduction of PVC content in the PVC should be able to prove the origin of the material by submitting documentary evidence. In the European Union, there are several certification schemes based on the EN 15343:2007(10) technical specification that can be used by ** vendors to support ** traceability declarations for **PVC. Given that law enforcement agencies lack the appropriate practical means to verify PVC-related requirements in imported articles, such requirements should be substantiated by independent third-party certification.
21) The specific pejorative connotations of the previously proposed lead pigments "lead thiochromate yellow" and "lead molybdate sulfate chromate red" should be removed from the draft regulations. In view of recent case law (11) and the intention of the Agency to submit a file on the limitations of the risks associated with the use of these two lead pigments in accordance with article 69 (2) of Regulation (EC) No 1907 2006, the Committee considers that derogations are no longer necessary.
22) In view of the low risk and lack of suitable alternatives, PVC-silica separators in lead-acid batteries should be exempted for 10 years after the entry into force of this regulation, after which suitable alternatives are expected to be available.
23) To avoid double regulation, exemptions should be made for articles that already have Regulation (EC) No 1907 2006 or other EU regulations regulating lead content in PVC.
24) Since the EU industry has not used lead stabilizers in PVC since 2015, 18 months is considered sufficient time for most economic operators to be able to adapt to the new requirements, dispose of their stocks and communicate relevant information about the restrictions in their **chain. In addition, the restriction should not apply to PVC products placed on the market before the end of that period, as this would create considerable enforcement difficulties.
25) Therefore, Regulation (EC) No 1907 2006 should be amended accordingly.
26) The measures provided for in this Regulation are in accordance with the opinion of the Commission established pursuant to Article 133 of Regulation (EC) No 1907 2006.
This Regulation has been adopted:
Article 1. Annex XVII of Regulation (EC) No 1907 2006 is amended in accordance with the Annex to this Regulation. Article 2.
This regulation enters into force on the 20th day after its publication in the Official Journal of the European Union.
The Regulations as a whole are binding and directly applicable to all Member States. May 3, 2023 in Brussels.
In June 2022, the European Commission drafted a regulation to amend Annex XVII of Regulation (EC) No 1907 2006 of REACH to add the following requirements on lead and lead compounds to the 63rd restriction on lead and lead compounds. The European Commission plans to approve this proposed amendment in the fourth quarter of 2022.
15.Must not be used in articles produced from polymers or copolymers (PVC) of vinyl chloride.
16.If the concentration of lead in PVC material (expressed as lead metal) is equal to or greater than 01% by weight, the PVC item must not be placed on the market.
17.Paragraphs 15 and 16 will be implemented from the corresponding date after 24 months + 1 day after the entry into force of this amended regulation.
18.As an exemption, paragraphs 15 and 16 do not apply to the following PVC articles containing recycled hard PVC until the corresponding date after 10 years after the entry into force of this amended regulation. Provided that the concentration of lead in recycled rigid PVC (in metal) is less than 15% by weight and the recycled rigid PVC has been covered with newly produced PVC or other material, and the lead concentration (in metal) of the overlay is less than 01% by weight:
a) Profiles and panels for the exterior of buildings and civil works, excluding decks and terraces;
b) profiles and panels for decks and terraces, provided that the recycled PVC is used in the middle layer and is completely covered by a layer of newly produced PVC or other materials;
c) Profiles and panels for concealed spaces or voids in buildings and civil works (inaccessible during normal use, excluding during repairs, e.g. cable ducts);
d) Profiles and panels used in the interior of the building, except that, after installation, the entire surface of the profile or panels facing the area of use of the building shall be made of newly produced PVC or other materials;
e) Multi-layer pipes (excluding drinking water pipes), provided that the recycled PVC is used in the middle layer and is completely covered by a layer of newly produced PVC or other materials;
f) Fittings, excluding fittings for drinking water pipes.
Hard PVC** in the categories mentioned in points (a) to (d) can only be used to produce new items in any of these categories.
PVC articles containing recycled hard PVC with a concentration of lead in PVC (as metal) equal to or greater than 01% by weight, the dealer of the PVC article should ensure that the "contains lead" is clearly and indestructibly marked "contains lead" before placing the item on the market. If it is not possible to label the article due to the nature of the article, it should be marked on the packaging.
Dealers of PVC articles containing recycled hard PVC** shall submit written supporting documents upon request from the law enforcement authorities of the Member States to prove the authenticity of the PVC claims in these products. Traceability and ingredient certificates issued by institutions, such as those issued in accordance with EN 15343:2007 or equivalent recognized standards, can be used to certify the authenticity of such claims for PVC articles produced in the EU. Claims of PVC in imported articles should be accompanied by a certificate of traceability and composition issued by an independent third-party agency to provide equivalent evidence.
By the corresponding date after 5 years after the entry into force of this amended regulation, the European Commission will review the requirements of this paragraph in the light of new scientific information and, where appropriate, amend accordingly.
19.As an exemption, paragraphs 15 and 16 do not apply to:
a) PVC-silica separators in lead-acid batteries, exempted until the corresponding date after 10 years after the entry into force of this amended regulation;
b) Items covered by paragraph 1 and the exemption conditions in paragraphs 2 to 5 are met. and items covered by paragraph 7 and meet the exemption conditions in paragraphs 8 and 10;
c) Items within the scope of the following directives and regulations:
i) Food Contact Materials (FCM) Regulation (EC) No 1935 2004;
ii) RoHS Directive 2011 65 EU;
iii) Packaging Directive 94 62 EC;
iv) Toy Safety Directive 2009 48 EC.
20.As an exemption, paragraph 16 does not apply to PVC articles placed on the market within 24 months of the entry into force of this amended regulation.
Current Annex XVII Item 63 Lead and its compounds ec231-100-4 cas.7439-92-1 Restrictions:
1.If any individual part of a jewelry product contains a lead content greater than or equal to 005% (weight percentage), it must not be placed on the market or used in the market.
2.In relation to Article 1:
i) "Jewellery Products" includes jewellery and imitation jewellery and headwear, including:
a) bracelets, necklaces and rings;
b) Precious jewelry; c) watches and wristbands;
d) Brooches and cufflinks.
ii) "Any individual part" shall include all materials used in the manufacture of the Jewellery and shall apply equally to any individual part of the Jewellery article.
3.Clause 1 also applies to individual parts of a piece of jewellery where they are intended to be placed on the market or added to the manufacture of jewellery.
4.As an exemption, Article 1 does not apply to:
a) Crystal glass as defined in Council Directive 69 493 EEC (Annex I and Class 4 of **);
b) the internal components of a watch product that are not accessible to consumers;
c) Precious and ornamental stones that are not synthetic or recycled (CN code 7103 under Regulation (EEC) No 2658 87), unless they are treated with lead or lead compounds or mixtures containing such substances;
d) Enamel, defined as a vitrified mixture obtained by the melting, vitrification or sintering of minerals at a temperature of at least 500 °C.
5.As an exemption, Clause 1 does not apply to jewellery products that were first placed before 9 October 2013 and jewellery products manufactured before 10 December 1961.
6.By 9 October 2017, the Committee shall reassess the viability of alternatives to Articles 1-5 above and the limits for lead in Article 1 in relation to articles in question, taking into account the latest scientific information, and, if necessary, revise this clause in the light of the relevant information.
7.Under normal and reasonably foreseeable circumstances, the lead content (in terms of lead) in articles that can be placed in the mouth of children and in accessible parts is greater than or equal to 005%, shall not be put on the market or ** for public use. This limit does not apply when the amount of lead emitted in an article or accessible parts of an article, whether or not it contains a coating, has been proven to be less than 005 g cm2 h (equivalent to 0.)05μg/g/h）；At the same time, for articles containing coatings, it is necessary to ensure that the amount of lead released by the coating does not exceed the upper limit for at least 2 years under normal and reasonably foreseeable circumstances. For the purposes of this paragraph, objects and accessible parts may be placed in a child's mouth on the basis that the dimensions of one side of the article are less than 5 cm, or that one of its detachable or protruding parts is less than 5 cm in size.
8.As an exemption from Section 7, the following products are exempt:
a) jewellery items that are already controlled in Article 1;
b) crystal glass as defined in Annex I (Categories 1, 2, 3 and 4) of the EU Directive 69 493 EEC;
c) Non-synthetic or recycled precious stones and ornamental stones (CN code 7103, under Regulation (EEC) No2658 87), unless it is treated with lead or lead compounds or mixtures containing such substances;
d) Enamel, defined as a vitrified mixture obtained by the melting, vitrification or sintering of minerals at a temperature of at least 500 °C.
e) keys and locks, including padlocks;
f) musical instruments; g) Articles or parts of articles composed of brass if the concentration of lead (in terms of lead) in brass does not exceed 05% (mass fraction);
h) the tip of the writing instrument;
i) religious articles;
j) portable zinc-carbon batteries and button cells;
k) Items within the following ranges:
i)Directive 94 62 EC EU Packaging Directive;
ii) Regulation (EC) No 1935 2004 EU Food Contact Materials Regulation; (iii) Directive 2009 48 EC Toy Safety Directive; (*iv) Directive 2011 65 EU RoHS 20。(*
9.By 1 July 2019, the Committee shall reassess the viability of alternatives to Articles 7 and 8(e), (f), (i) and (j) in the light of the latest scientific and technical information, as well as the limits for lead in Article 7 (including the integrity requirements of coatings) in Article 7 in relation to articles, and, if necessary, revise these Articles in the light of relevant information.
10.As an exemption, products that were first placed on the market before 1 June 2016 are exempt from Article 7.
11.After February 15, 2023, it is forbidden to do any of the following in the wetland or within 100 meters of the wetland:
a) Shoot bullets containing more than or equal to 1% lead by weight of metal;
b) Carrying such ammunition in or in connection with wet shooting. For the purposes of paragraph 1;
c) "Within 100 m of the wetland" means a distance of 100 m from any boundary point of the wetland;
d) "Shooting in a wetland" means shooting in or within a 100-metre area of a wetland;
e) Shooting in a wetland or within 100 metres of a wetland is considered to be a shooting at or in connection with a shooting at a person who is carrying a firearm unless the person has evidence that he or she is engaged in another type of shooting. The limitation in paragraph 1 of this Article shall not apply to Member States that have notified the Committee of their intention to opt for that restriction in accordance with Article 12.
12.Member States with wetlands that occupy 20% or more of their total territory (excluding water area) may elect to prohibit the following acts on a global scale from 15 February 2024 in lieu of the restrictions set out in Article 11, subparagraph 1:
a) placing on the market ammunition with a lead content greater than or equal to 1 per cent by weight of metal;
b) the firing of such bullets;
c) Carrying such ammunition in or in connection with the shooting.
Any Member State wishing to opt for the restrictions set out in paragraph 1 of this Article shall notify the Committee by August 15, 2021, and in a timely manner by August 15, 2023, of the content of the measures it has taken. The Committee shall immediately make these notifications of intent and the details of the measures public.
13.In the case of Articles 11 and 12:
a) "Wetland" means natural or artificial, permanent or temporary marshland, peatland or water area, with still or flowing fresh, brackish or saline water bodies, including sea areas with a depth of not more than 6 metres at low tide;
b) "Bullet" means a bullet used or intended to be used in a single shot or magazine of a shotgun;
c) "Shotgun" means a smoothbore gun, excluding **;
d) "Shooting" means shooting with a shotgun;
e) "Carrying" means carrying or transporting by a person or by other means;
f) in determining whether a person is involved in carrying a firearm or ammunition in connection with the shooting;
i) all the circumstances of the case should be taken into account;
ii) It should be considered that the person carrying the bullet and the shot are not necessarily the same person. 14.Member States may retain the provisions on restricting lead in bullets to protect the environment and human health by 15 February 2021 and are more stringent than those in Article 11. Member States should immediately inform the Committee of the content of these provisions. The Committee shall make the contents of these provisions public without delay. (*ojl326,29.12.1969,p.36.(*ojl170,30.6.2009,p.1.(*oj l174,1.7.2011,p.88.
**：eur-lex.europa.eu