The last resort requirement under REACH: From principle to practice.

Autor: Macmillan DS; Humane Society International/Europe, Av. des Arts 50, 1000, Bruxelles, Belgium. Electronic address: dmacmillan@hsi.org., Bergqvist A; Global Product Compliance (Europe) AB, Ideon Beta 5, Scheelevägen 17, 223 63, Lund, Sweden., Burgess-Allen E; Procter & Gamble, Reading, United Kingdom., Callan I; Innospec Limited, Oil Sites Road, Ellesmere Port, Cheshire, CH65 4EY, United Kingdom., Dawick J; Innospec Limited, Oil Sites Road, Ellesmere Port, Cheshire, CH65 4EY, United Kingdom., Carrick B; Kenvue, Johnson & Johnson Consumer Services EAME Ltd, 50-100 Holmers Farm Way, High Wycombe, HP12 4EG, United Kingdom., Ellis G; DSM-Firmenich, Rue de la Bergere 7, Satigny, Switzerland., Ferro R; Unilever, Via Lever Gibbs 3, Casalpusterlengo, LO, Italy., Goyak K; ExxonMobil Biomedical Sciences, Inc., 1545 US Route 22 East, Annandale, NJ, 08801, United States., Smulders C; Shell, Global Solutions B.V., Den Haag, the Netherlands., Stackhouse RA; Sasol, 12120 Wickchester Lane, Houston, TX, 77079, United States., Troyano E; Procter & Gamble, Mason, OH, United States., Westmoreland C; Safety & Environmental Assurance Centre, Unilever, Colworth Science Park, Sharnbrook, United Kingdom., Ramón BS; ECETOC, 4 Avenue E. Van Nieuwenhuyse (Bte 6), B-1160, Brussels, Belgium., Rocha V; Givaudan, 717 Ridgedale Ave, East Hanover, NJ, 07936, United States., Zhang X; Procter & Gamble, Mason, OH, United States.
Jazyk: angličtina
Zdroj: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 Feb; Vol. 147, pp. 105557. Date of Electronic Publication: 2023 Dec 23.
DOI: 10.1016/j.yrtph.2023.105557
Abstrakt: REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is a European Union regulation that aims to protect human health and the environment from the risks posed by chemicals. Article 25 clearly states that: "[i]n order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort." In practice, however, the standard information requirements under REACH are still primarily filled using animal studies. This paper presents examples illustrating that animal testing is not always undertaken only as a last resort. Six over-arching issues have been identified which contribute to this: (1) non-acceptance of existing animal or non-animal data, (2) non-acceptance of read-across, (3) inflexible administrative processes, (4) redundancy of testing, (5) testing despite animal welfare concerns and (6) testing for cosmetic-only ingredients. We, members of the Animal-Free Safety Assessment (AFSA) Collaboration, who work together to accelerate the global adoption of non-animal approaches for chemical safety assessment, herein propose several recommendations intended to aid the European Commission, the European Chemicals Agency and registrants to protect human health and the environment while avoiding unnecessary animal tests - truly upholding the last resort requirement in REACH.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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