Regulatory Framework

From a regulatory point of view, the main driver for improving sustainability within the European Union has been the Waste Framework Directive (EU Directive 2008/98/EC). Other European Directives impact specific sectors, such as the European Directives on End-of-Life Vehicles, Packaging and Waste Electric and Electronic Equipment (WEEE). In addition, many Member States restrict disposal of plastics in landfill through national regulation.

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.

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
ECHA worked on the restrictions under consideration for PVC containing lead compounds.
In their opinions, respectively adopted on 5 December 2017 and 15 March 2018, ECHA’s Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) confirmed that recycling should be considered as an appropriate risk management measure. They proposed a revision of the lead content limits for articles containing recycled PVC, to 1% for soft PVC and up to 2% for rigid PVC. A condition for these revised limits would be that, in soft applications and in specific rigid applications, the lead-containing recycled PVC be entirely encapsulated within a layer of virgin PVC.

In 2018, RDC Environment carried out an evaluation study, Technology and Economic Feasibility of Soft PVC Encapsulation. This study concluded that, while technically feasible for sheets (multilayers), the cost of encapsulation would be prohibitively expensive except for higher-value products. For most of the remaining products (traffic management, roofing tiles, boots for professional use), the technical feasibility of encapsulating the recyclates within layers of virgin PVC is unknown or at least not readily available. Most probably, it is excessively expensive.

In November 2019, the REACH Committee accepted the European Chemical Agency’s (ECHA) proposal of the lead-content limits revision for articles containing recycled PVC, with a derogation period of 15 years, to be reviewed after 7.5 years. The draft regulation was sent for scrutiny to the European Parliament and Council. On 21 January 2020, the European Parliament ENVI Committee adopted a motion for resolution objecting to the draft EU Commission regulation, considering it incompatible with the aim and content of the REACH Regulation. On 12 February 2020, a plenary session of the European Parliament voted in favour of this resolution objecting to the draft Commission regulation. The draft proposal was then returned to the Commission for review.

Cadmium Restriction
EU Commission Regulation 494/2011 set a limit for polymers of 100 ppm of cadmium, with a derogation of up to 1,000 ppm allowed in specified rigid PVC construction products for cadmium originating from recyclates. These limits were scheduled to be reviewed by 31 December 2017.

In 2016, the European Commission asked ECHA to carry out a review of the cadmium restrictions by September 2017. As part of this review, ECHA contracted VITO, which had already in 2009 developed an impact assessment of various possible options to reconcile the recycling of PVC waste containing legacy cadmium with the restrictions of Annex XVII of REACH. The VITO study was completed in May 2017.

On 02 June 2021, the European Chemicals Agency (ECHA) published its report evaluating the current concentration limits for cadmium in recycled PVC. The report was commissioned by the EU Commission and now serves as a basis for possible further action. The 108-page paper deals with the exemption for the restriction of cadmium and its compounds in products containing recycled PVC. The restriction includes a general limit of 0.01% by weight for cadmium compounds. However, certain uses containing recycled PVC are allowed to be placed on the market with a higher concentration value of 0.1% by weight.

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.

An online database of polymers and applications has been developed to support PVC recyclers to comply with the REACH requirements. This tool enables recyclers to access the necessary ‘Safety Data Sheets for Recyclers’ ( and published guidance documents.

DEHP Authorization

The authorization to use recycled PVC with DEHP under certain conditions was granted on April 20, 2016 and published in OJ by the commission 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.

The Restriction of Hazardous Substances (RoHS) Directive restricts use of hazardous substances in electrical and electronic equipment. The maximum concentration values tolerated by weight in homogeneous materials are the following for PVC relevant substances: 0.1 % for lead and 0.01 % for cadmium. The phthalates DEHP, BBP, DBP and DIBP are also restricted with a 0.1 % concentration limit, as from 22nd July 2019 (22nd July 2021 in the case of medical devices).

A methodology for the identification and assessment of additional substances to be potentially included in the list of restricted substances has been developed by consultant Öko Institut on behalf of the EU Commission. Two substances relevant for PVC, namely antimony trioxide and medium chain chlorinated paraffins are among the first set of substances to be evaluated under this new methodology.

An exemption for cadmium and lead in windows equipped with electrical devices has been requested for profiles containing recycled PVC. The Commission assured industry it will be aligned on the REACH restrictions.

Circular EconomyRegulatory Framework