Regulatory Framework

Legacy additives are substances that are no longer used in new PVC products but that can be present in recycled PVC. Since the use of legacy additives may be restricted by legislation, VinylPlus is committed to addressing the issue in cooperation with regulatory authorities.

Research on legacy additives

Over the years, VinylPlus has contributed to discussions on legacy additives by supporting research and a considerable number of studies.
In 2017, studies commissioned by VinylPlus focused particularly on lead, in relation to ECHA’s proposal to restrict the use of recyclates containing it.
They covered modelling (by FABES) and risk assessments (by ARCHE Consulting) of lead migration, as well as a cost-benefit analysis of recycling PVC applications containing lead (by RDC Environment).

The FABES study Modelling Migration of Lead Compounds from Monolayer Unplasticised Polyvinylchloride Sewer Pipes connecting Houses with the Public Sewer System showed that the lead concentration in water decreases very rapidly after a few hours, and that the total depletion of lead in a pipe takes “much more than 100 years”.
Modelling on Lead Migration from Plasticised PVC into Water, another study by FABES, showed no difference in leaching amounts between thick and thin P-PVC samples. This is because, even in the thin P-PVC sample, the lead compound depletion did not reach the median area of the sample. A further FABES study, Modelling on Lead Migration from Various Rigid PVC Applications, provided data for the risk assessments of lead migration commissioned to ARCHE Consulting.

The study Risk Assessment of Lead Migration during Service Life of Articles containing Recycled PVC in a typical City of 10,000 Inhabitants by ARCHE Consulting concluded that “the local contributions due to combined leaching of lead from all uses of recycled PVC are negligible compared to the regional lead background concentrations for water, sediment and soil stemming from other sources”. It showed “the absence of risks for the environment and for indirect exposure of humans via the environment”.
A second risk assessment by ARCHE found that the migration of lead is so negligible that there are no risks via dermal or oral exposure to lead migrating out of products made from PVC recyclate.

RDC Environment’s cost-benefit analysis of recycling PVC applications containing lead concluded that from the economic viewpoint, recycling PVC waste is environmentally preferable and more economically efficient than incinerating or landfilling it; that recycling PVC waste creates more jobs than incineration or landfill; and that the human health impact due to lead leaching from recycled PVC applications is small compared to the environmental, economic and job-creation benefits. To complete the socio-economic assessment, further analysis by RDC evaluated the cost-efficiency of avoided lead emissions without derogation and of the socio-economic impact of hazardous waste regulations applying to PVC waste.

Lead restriction

On 3 May 2023, the European Commission adopted a REACH restriction on lead and its compounds in PVC.
This restriction bans the import of lead-containing PVC products from third countries where lead is still used as a stabiliser, and sets a way forward to enable the recycling of PVC products containing legacy lead additives in a manner which safeguards human health and the environment.
Additionally, the industry is given time through derogations to adjust to the new rules, ensuring the continuity of recycling and enabling the industry’s contribution to the EU’s circular economy.

What does the restriction say? 

The final text contains the following provisions:

General restriction: A restriction of PVC articles if the concentration of lead is equal to or greater than 0,1 % by weight of the PVC material.
This will apply 18 months + 1 day following the regulation’s entry into force.

Derogation: The above restriction shall not apply for 10 years to the following PVC articles containing recovered PVC, provided the concentration of lead is lower than 1,5 % by weight of the recovered rigid PVC:

• • • profiles and sheets for exterior applications in buildings and civil engineering works, excluding decks and terraces;
    • 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;
    • 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)
    • 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;
    • 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;
    • fittings, excluding fittings for pipes for drinking water.

    Closed loop recycling: 36 months after entry into force, categories of articles in points (a) to (d) shall only be used for the production of new articles of any of those categories

    Labelling: 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 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.

    Recycled waste streams may contain cadmium. The placing on the market of polymers containing cadmium is restricted by an amendment (Regulation 494/2011 of 20 may 2011) of Annex XVII of REACH. This amendment allows higher cadmium content in rigid construction products if the cadmium originates from recycling. The industry is working with the relevant EU authorities to ensure that recycling activities remain sustainable while complying with the current regulatory regime.

     

    DEHP Authorization

    The authorization to use recycled PVC with DEHP under certain conditions was granted on April 20, 2016 and published in the European Commission’s Official Journal by on June 16, 2016.
    It concerns the formulation of recycled soft poly(vinyl chloride – PVC) containing DEHP in compounds and dry-blends and authorizes the industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce PVC articles except: toys and childcare articles, erasers, adult toys (sex toys and other articles for adults with intensive contact with mucous membranes), household articles smaller than 10 cm that children can suck or chew on, consumer textiles/clothing intended to be worn against the bare skin, cosmetics and food contact materials regulated under sector-specific Union legislation.

    The authorization was granted in accordance with Article 60(4) of Regulation (EC) No 1907/2006: the socioeconomic benefits outweigh the risk to human health arising from the use of the substance and there are no suitable alternative substances or technologies in terms of their technical and economic feasibility for the applicants and some of their downstream users. It expired in February 2019.

    In Summer 2017, Vinyloop (which announced closure of its business in Ferrara in June 2018) and Plastic Planet submitted a review report to ECHA in view of the extension of the authorization for recycled PVC containing DEHP. In September 2018 both RAC and SEAC recommended the extension of the authorization for another 7 years (link), however the EU Commission has not yet published its final decision.

    In 2020, European Plasticisers contributed to the European Commission public consultation on amending the Authorisation List (Annex XIV of REACH) entries by adding the four phthalates DEHP, BBP, DBP and DIBP for their endocrine disrupting properties. Since these four phthalates were already on Annex XIV for the same adverse effects (reproductive effects), European Plasticisers expressed concern for the over-regulation of these substances. Once the European Commission decides on the amendment, some previously REACH-exempted uses will require authorisation. For example, if DEHP is listed as an endocrine disruptor for the environment, authorisation applications will have to be submitted for it to be used in food-contact materials and medical devices.

     

    Low Molecular Weight Phthalates Restriction

    The European Commission has adopted a Decision to amend the REACH Regulation and restrict the use of the phthalates, DEHP, BBP, DBP and DIBP in consumer products on the EU market  (Commission Regulation (EU) 2018/2005 of 17 December 2018, link). The regulation was published in Official Journal on January 7, 2019, and the transition period to comply with proposed measures is 18 months (until July 7, 2019). According to the legislation,  which will take effect from 8 July 2020, the four substances will be restricted to a concentration equal to or below 0.1% by weight individually or in any combination in any plasticised material in articles used by consumers or in indoor areas.

    In June 2019, the European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) issued guidelines for the use of DEHP in medical devices as included in the new medical device regulation (Regulation (EU) 2017/745), which will enter into force on 26 May 2020.

    In December 2019, EFSA issued an update of the risk assessment of the phthalates DBP, BBP, DEHP, DINP and DIDP for use in food-contact materials. EFSA’s CEP Panel concluded that “current exposure to these five phthalates from food is not a concern for public health”. Nevertheless, on a temporary basis, it adopted a group TDI (tolerable daily intake) limit of 50 µg/kg of body weight (bw) per day for the combined total intake of DBP, BBP, DEHP, DINP, and confirmed a TDI of 150 µg/kg of bw per day for DIDP.

    As of 7 July 2020, the use of the low molecular weight orthophthalates DEHP, DBP, DIBP and BBP has been restricted in articles produced in or imported to Europe. They cannot be used in a concentration greater than or equal to 0.1% by weight of the plasticised material.

    Phthalates risk assessment

    The updated EFSA risk assessment of the phthalates DBP, BBP (Butyl benzyl phthalate), DEHP (Di(2-ethylhexyl) phthalate), DINP and DIDP for use in food-contact materials (December 2019), concluded that “current exposure to these five phthalates from food is not a concern for public health” (source). Nevertheless, based on the limited scope of the mandate and the uncertainties identified, the EFSA’s CEP Panel considered that the current assessment of the five phthalates, individually and collectively, should be on a temporary basis. Further evaluations of a broad range of plasticisers (39 in total) are now in progress. In November 2020, EFSA received a new mandate from the EU Commission and will now address the limitations of the work carried out in the previous mandate; prioritise and identify phthalates, structurally similar substances and replacement substances; and establish a protocol for dietary exposure assessment to and hazard assessment of the prioritised substances. European Plasticisers will keep providing data and other relevant information as appropriate.