Regulatory

Plasticisers have been subject to extensive testing and rigorous risk assessments. Since the implementation of REACH, more than 50 substances with plasticising properties have been registered. Specific plasticisers are restricted under EU REACH (Annex XVII) or are subject to REACH Authorisations (Annex XIV). Most of the modern plasticisers are neither classified as hazardous nor are they regulated, meaning they are safe to be used.

The industry’s current use of plasticisers is the result of a careful and technically sound selection of substances and an ongoing substitution process. Over the last three decades, the industry has been shifting from low-molecular-weight (LMW) ortho-phthalates, which are listed as Substances of Very High Concern (SVHC), to safer high-molecular weight (HMW) ortho-phthalates and other plasticisers.

Substances which are identified as SVHC are placed on the REACH Candidate List and then prioritised for inclusion in the REACH Authorisation List (Annex XIV of REACH). These substances are then subject to application for Authorisation for specific uses. Currently, the REACH Authorisation lists 14 phthalates including:

DEHP Di(2-ethylhexyl) phthalate; DBP (Dibutyl phthalate); DIBP (Di-isobentyl phthalate); BBP (Benzyl butyl phthalate); 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich; bis(2-methoxyethyl) phthalate; DNPP (dipentyl phthalate).

Since 1999 certain phthalates including DINP, DIDP, and DNOP may not be used as substances or in mixtures, in concentrations greater than 0,1 % by weight of the plasticised material intended for toys and childcare articles – Decision 1999/815/EC. And this decision has been prolonged several times until the permanent restriction was published in Directive 2005/84/EC. The restriction ended up with other regulations in Annex XVII, entries 51 and 52 of REACH (Reg (EU) No 1907/2006. Commission regulation (EU) 2018/2005 added DiBP to the entry 51 of Annex XVII.

In addition, since November 2020, the concentration limit for certain plasticisers in consumer clothing, footwear and textile amounts to 1 000 mg/kg (individually or in combination with other phthalates in Annex XVII of REACH).

In 2022, the European Commission published the Restrictions Roadmap under the Chemicals Strategy for Sustainability. As set under the Restrictions Roadmap, the European Chemicals Agency (ECHA) published the investigation report in November 2023. Information on plasticisers in polyvinylchloride (PVC). In light of the investigation, European Plasticisers highlights the importance of ensuring regulatory predictability for the value chain and stands prepared to assist the European authorities in the assessment of PVC and PVC Additives.

As set out in the EU’s Medical Devices Regulation, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) developed guidelines on the benefit-risk assessment of the presence of phthalates. First published in 2019, the guidelines are now undergoing assessment and update.

With the exemption of medical devices, under the Restriction of Hazardous Substances Directive (RoHS) the use of BBP, DBP, DEHP and DIBP is not allowed in some products with an electrical and electronic component.

Plasticisers, including DIBP, BBP, DEHP and DINP, are also regulated in plastic materials and articles intended to come into contact with food. In 2019, the European Food Safety Authority (EFSA) updated the risk assessment for the phthalates DBP, BBP, DEHP, DINP and DIDP for use in food contact materials, leading to proposed Tolerable Daily Intakes (TDIs) for phthalates on a temporary basis. In addition, EFSA concluded that the current exposure to these five phthalates from food is not a concern for public health. In 2020, EFSA was tasked to re‐evaluate the potential risks to public health related to the presence of plasticisers and address the limitations present in the previous mandate.