Evidence map›Paper›PMID 42369420›Full record

ArticleNAM journal2025

Highlighting best practices to advance next-generation risk assessment of cosmetic ingredients.

Eric Vaillancourt, Alaa Afdal Mohamed, Jay Ansell, Takao Ashikaga, Ahmed Ayad, Hadeel Ayman, Marize Valadares Campos, Han-Sheng Chien, Arianna Giusti, Masato Hatao and 18 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in NAM journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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.

Eric VaillancourtHealth Canada, Healthy Environments and Consumer Safety Branch, 269 Laurier Ave. W., Ottawa, Ontario K1A 0K9, Canada.
Alaa Afdal MohamedEgyptian Drug Authority (EDA), Egypt.
Jay AnsellUS Personal Care Products Council (PCPC), 555 13 Street NW, WA, DC 20004, USA.
Takao AshikagaNational Institute of Health Sciences (NIHS), Japan.
Ahmed AyadChamber of Pharmaceutical Industries, Cosmetics and Medical Devices, Federation of Egyptian Industry (CPCMD), Egypt.
Hadeel AymanEgyptian Drug Authority (EDA), Egypt.
Marize Valadares CamposBrazilian Health Regulatory Agency (ANVISA), Gerência-Geral de Cosméticos e Saneantes, Setor de Indústria e Abastecimento (SIA), Trecho 5, Área Especial 57, CEP 71205-050, Brasília, DF, Brazil.
Han-Sheng ChienTaiwan Food and Drug Administration (TFDA), Chinese Taipei.
Arianna GiustiCosmetics Europe, The Personal Care Association, Avenue Herrmann Debroux 40, 1160 Brussels, Belgium.
Masato HataoJapan Cosmetic Industry Association (JCIA), Metro City Kamiyacho 6F, 5-1-5, Toranomon, Minato-ku, Tokyo 105-0001, Japan.
Frances HillOffice for Product Safety and Standards (OPSS), UK.
Abeer KhattabEgyptian Drug Authority (EDA), Egypt.
Reinhard KreilingClariant Produkte (Deutschland) GmbH, Am Unisyspark 1, 65843, Sulzbach, Germany.
Ah Young LeeKorean Cosmetics Association (KCA), Republic of Korea.
Miao LiUS Food and Drug Administration (US FDA), 5001 Campus Drive, College Park, MD 20740, USA.
Pinpin LinNational Health Research Institutes, Taiwan.
Yen-Chun LinTaiwan Food and Drug Administration (TFDA), Chinese Taipei.
Victor MencarelliIndependent Beauty Association (IBA), United States, 14901 Quorum Drive, Suite #630, Addison, TX 75254, USA.
Stanley MilsteinUS Food and Drug Administration (US FDA), 5001 Campus Drive, College Park, MD 20740, USA.
Beta P MontemayorCosmetics Alliance Canada, 420 Britannia Road East, Suite 102, Mississauga, ON L4Z 3L5, Canada.
Carolina Motter CatarinoAssociation of the Cosmetic, Toiletry and Fragrance Industry (ABIHPEC), Av. Paulista, 1313 Cerqueira César, São Paulo, SP 01311-000, Brazil.
Rawda NegmEgyptian Drug Authority (EDA), Egypt.
Gladys OuédraogoL'Oréal, Research and Development, Paris, France.
Eun Jae ParkMinistry of Food and Drug Safety (MFDS), Republic of Korea.
Mustafa VarçinCosmetics Europe, The Personal Care Association, Avenue Herrmann Debroux 40, 1160 Brussels, Belgium.
Tzu-Yi YangTaiwan Food and Drug Administration (TFDA), Chinese Taipei.
Yu Janet ZangUS Food and Drug Administration (US FDA), 5001 Campus Drive, College Park, MD 20740, USA.
Matthew Philip DentUnilever Safety, Environmental and Regulatory Science, Sharnbrook, Bedfordshire, MK44 1LQ, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Public expectations and regulatory demands have driven a paradigm shift in cosmetic ingredient safety assessment. Next-generation risk assessment (NGRA) and new approach methodologies (NAMs) provide an opportunity to implement alternative procedures which are more ethical and biologically-relevant, have the potential to become more cost-effective and time-efficient, and are at least as protective of human health as traditional, animal-based approaches. However, the sheer number and diversity of the rapidly-evolving NAMs currently available can be confusing and overwhelming to safety assessors. To successfully transition from principles to routine application, NAMs must gain acceptance within safety assessment communities. Harmonizing NAMs and establishing standardized risk assessment workflows are paramount to gaining regulatory acceptance. Consequently, the International Cooperation on Cosmetics Regulation (ICCR) has tasked a team of scientists from regulatory authorities and the cosmetic industry to define best practices which align with the ICCR principles of NGRA for cosmetic ingredients, to help advance the acceptance and use of NAMs in cosmetic safety assessment and, where applicable, regulatory decision-making.

Indexed as

Cosmetic ingredient safetyCosmetics risk assessmentNew approach methodologiesNext-generation risk assessmentNon-animal approaches

Identifiers

PMID42369420
PMCPMC13288993

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.