Three-tiered approach for standard information requirements for polymers requiring registration under REACH

• Published in: Regulatory toxicology and pharmacology Vol. 144; p. 105495
• Main Authors: Otte, Jens C., Hollnagel, Heli Miriam, Nagel, Christiane, Gerhardt, Renata Friederike, Wohlleben, Wendel, Vallotton, Nathalie, Schowanek, Diederik, Sanders, Gordon, Frasca, Joe M., Mahale, Tushar, Pemberton, Mark, Hidding, Bjoern, Landsiedel, Robert
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.10.2023
• Subjects: Bioavailability; Exposure; Hazard; Information requirements; Polymers; REACH; Risk; Tiered-testing; REACH; Tiered-testing; Risk; Exposure; Information requirements; Bioavailability; Polymers; Hazard
• ISSN: 0273-2300; 1096-0295
• DOI: 10.1016/j.yrtph.2023.105495

Polymers are a very large class of chemicals comprising often complex molecules with multiple functions used in everyday products. The EU Commission is seeking to develop environmental and human health standard information requirements (SIRs) for man-made polymers requiring registration (PRR) under a revised Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation. Conventional risk assessment approaches currently used for small molecules may not apply to most polymers. Therefore, we propose a conceptual three-tiered regulatory approach for data generation to assess individual and groups of polymers requiring registration (PRR). A key element is the grouping of polymers according to chemistry, physico-chemical properties and hazard similarity. The limited bioavailability of many polymers is a prominent difference to many small molecules and is a key consideration of the proposed approach. Methods assessing potential for systemic bioavailability are integral to Tier 1. Decisions for further studies are based on considerations of properties and effects, combined with systemic bioavailability and use and exposure considerations. For many PRRs, Tier 1 data on hazard, use and exposure will likely be sufficient for achieving the protection goals of REACH. Vertebrate animal studies in Tiers 2 and 3 can be limited to targeted testing. The outlined approach aims to make use of current best scientific evidence and to reduce animal testing whilst providing data for an adequate level of protection. •Conventional risk assessment approaches under REACH may not be suitable to polymers.•Tiered information requirements can reduce animal testing whilst maintaining adequacy.•Polymer grouping, and assessment of systemic bioavailability, are key aspects of the tiered approach.•Use of New approach methodologies (NAMs) can be applied as part of the tiered testing.•Tier 1 information, which excludes vertebrate testing, may be sufficient for many polymers.