Evidence map›Paper›PMID 34389358›Full record

ArticleRegulatory toxicology and pharmacology : RTP2021

Paving the way for application of next generation risk assessment to safety decision-making for cosmetic ingredients.

M P Dent, E Vaillancourt, R S Thomas, P L Carmichael, G Ouedraogo, H Kojima, J Barroso, J Ansell, T S Barton-Maclaren, S H Bennekou and 18 more

Abstract read
In one paragraph

Article in Regulatory toxicology and pharmacology : RTP, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  13. Key attributes of health and environmental risk decision-making: A scoping review.Risk analysis : an official publication of the Society for Risk Analysis · 2025
    Article
  14. Review
  15. Article
  16. Advancing systemic toxicity risk assessment: Evaluation of a NAM-based toolbox approach.Toxicological sciences : an official journal of the Society of Toxicology · 2025
    Article
  17. Review
  18. Incorporating new approach methods (NAMs) data in dose-response assessments: The future is now!Journal of toxicology and environmental health. Part B, Critical reviews · 2025
    Review
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

M P DentUnilever Safety and Environmental Assurance Centre, Sharnbrook, Bedfordshire, MK44 1LQ, UK. Electronic address: matthew.dent@unilever.com.
E VaillancourtHealth Canada, Healthy Environments and Consumer Safety Branch, 269 Laurier Ave. W., Ottawa, ON K1A 0K9, Canada. Electronic address: eric.vaillancourt@canada.ca.
R S ThomasCenter for Computational Toxicology and Exposure, U.S. Environmental Protection Agency, Research, Triangle Park, NC, 27711, USA. Electronic address: thomas.russell@epa.gov.
P L CarmichaelUnilever Safety and Environmental Assurance Centre, Sharnbrook, Bedfordshire, MK44 1LQ, UK. Electronic address: paul.carmichael@unilever.com.
G Ouedraogol'Oréal, Research and Development, Paris, France. Electronic address: gouedraogo@rd.loreal.com.
H KojimaNational Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, 158-8501, Tokyo, Japan. Electronic address: h-kojima@nihs.go.jp.
J BarrosoEuropean Commission, Joint Research Centre (JRC), Ispra, VA, Italy. Electronic address: joao.barroso@ec.europa.eu.
J AnsellUS Personal Care Products Council (PCPC), 1620 L St. NW, Suite 1200, Washington, D.C, 20036, USA. Electronic address: ansellj@personalcarecouncil.org.
T S Barton-MaclarenHealth Canada, Healthy Environments and Consumer Safety Branch, 269 Laurier Ave. W., Ottawa, ON K1A 0K9, Canada. Electronic address: tara.barton-maclaren@canada.ca.
S H BennekouNational Food Institute, Technical University of Denmark (DTU), Copenhagen, Denmark. Electronic address: shobe@food.dtu.dk.
K BoekelheideDepartment of Pathology and Laboratory Medicine, Brown University, Providence, RI, USA. Electronic address: kim_boekelheide@brown.edu.
J EzendamNational Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands. Electronic address: janine.ezendam@rivm.nl.
J FieldHealth Canada, Healthy Environments and Consumer Safety Branch, 269 Laurier Ave. W., Ottawa, ON K1A 0K9, Canada. Electronic address: john.field@canada.ca.
S FitzpatrickUS Food and Drug Administration (US FDA), Center for Food Safety and Applied Nutrition (CFSAN), 5001 Campus Drive, College Park, MD, 20740, USA. Electronic address: suzanne.fitzpatrick@fda.hhs.gov.
M HataoJapan Cosmetic Industry Association (JCIA), Metro City Kamiyacho 6F, 5-1-5, Toranomon, Minato-ku, Tokyo, 105-0001 Japan. Electronic address: hatao@jcia.org.
R KreilingClariant Produkte (Deutschland) GmbH, Am Unisyspark 1, 65843, Sulzbach, Germany. Electronic address: reinhard.kreiling@clariant.com.
M LorenciniGrupo Boticário, Research & Development, São José dos Pinhais, Brazil. Electronic address: marciolo@grupoboticario.com.br.
C MahonyProcter & Gamble Technical Centres Ltd, Reading, RG2 0RX, UK. Electronic address: mahony.c@pg.com.
B MontemayorCosmetics Alliance Canada, 420 Britannia Road East Suite 102, Mississauga, ON L4Z 3L5, Canada. Electronic address: bmontemayor@cosmeticsalliance.ca.
R Mazaro-CostaDepartament of Pharmacology, Universidade Federal de Goiás, Goiânia, GO, 74.690-900, Brazil. Electronic address: mazaro@ufg.br.
J OliveiraBrazilian Health Regulatory Agency (ANVISA), Gerência de Produtos de Higiene, Perfumes, Cosméticos e Saneantes, Setor de Indústria e Abastecimento (SIA), Trecho 5, Área Especial 57, CEP 71205-050, Brasília, DF, Brazil. Electronic address: julcemara.oliveira@anvisa.gov.br.
V RogiersVrije Universiteit Brussel, Brussels, Belgium. Electronic address: Vera.Rogiers@vub.be.
D SmegalUS Food and Drug Administration (US FDA), Center for Food Safety and Applied Nutrition (CFSAN), 5001 Campus Drive, College Park, MD, 20740, USA. Electronic address: deborah.smegal@fda.hhs.gov.
R TaalmanCosmetics Europe, Avenue Herrmann-Debroux 40, 1160 Auderghem, Belgium. Electronic address: rtaalman@cosmeticseurope.eu.
Y TokuraAllergic Disease Research Center, Chutoen General Medical Center, Kakegawa, Japan. Electronic address: tokura@med.uoeh-u.ac.jp.
R VermaUS Food and Drug Administration (US FDA), Center for Food Safety and Applied Nutrition (CFSAN), 5001 Campus Drive, College Park, MD, 20740, USA. Electronic address: rajeshwar.verma@fda.hhs.gov.
C WillettHumane Society International, Washington, DC, USA. Electronic address: kwillett@humanesociety.org.
C YangTaiwan Cosmetic Industry Association (TWCIA), 8F No. 136, Bo'ai Rd., Zhongzheng Dist., Taipei City, 100, Taiwan, ROC. Electronic address: k77982@kao.com.tw.

Funding

Intramural EPA EPA999999
6 · The paper itself

Abstract

Next generation risk assessment (NGRA) is an exposure-led, hypothesis-driven approach that has the potential to support animal-free safety decision-making. However, significant effort is needed to develop and test the in vitro and in silico (computational) approaches that underpin NGRA to enable confident application in a regulatory context. A workshop was held in Montreal in 2019 to discuss where effort needs to be focussed and to agree on the steps needed to ensure safety decisions made on cosmetic ingredients are robust and protective. Workshop participants explored whether NGRA for cosmetic ingredients can be protective of human health, and reviewed examples of NGRA for cosmetic ingredients. From the limited examples available, it is clear that NGRA is still in its infancy, and further case studies are needed to determine whether safety decisions are sufficiently protective and not overly conservative. Seven areas were identified to help progress application of NGRA, including further investments in case studies that elaborate on scenarios frequently encountered by industry and regulators, including those where a 'high risk' conclusion would be expected. These will provide confidence that the tools and approaches can reliably discern differing levels of risk. Furthermore, frameworks to guide performance and reporting should be developed.

Indexed as

Animal Testing AlternativesConsumer Product SafetyCosmeticsRisk AssessmentCosmeticsIn silicoIn vitroNext generation risk assessmentNon-animal approaches

Identifiers

PMID34389358
PMCPMC8547713

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.