Evidence map›Paper›PMID 33851225›Full record

ReviewArchives of toxicology2021

Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies.

Francesca Pistollato, Federica Madia, Raffaella Corvi, Sharon Munn, Elise Grignard, Alicia Paini, Andrew Worth, Anna Bal-Price, Pilar Prieto, Silvia Casati and 3 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Archives of toxicology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing 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

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

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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

13 authors.

Francesca PistollatoDirectorate F-Health, Consumers and Reference Materials, Unit F3 Chemicals Safety and Alternative Methods, European Commission, Joint Research Centre (JRC), Via E. Fermi, 2749. TP126, 21027, Ispra, VA, Italy.
Federica MadiaDirectorate F-Health, Consumers and Reference Materials, Unit F3 Chemicals Safety and Alternative Methods, European Commission, Joint Research Centre (JRC), Via E. Fermi, 2749. TP126, 21027, Ispra, VA, Italy.
Raffaella CorviDirectorate F-Health, Consumers and Reference Materials, Unit F3 Chemicals Safety and Alternative Methods, European Commission, Joint Research Centre (JRC), Via E. Fermi, 2749. TP126, 21027, Ispra, VA, Italy.
Sharon MunnDirectorate F-Health, Consumers and Reference Materials, Unit F3 Chemicals Safety and Alternative Methods, European Commission, Joint Research Centre (JRC), Via E. Fermi, 2749. TP126, 21027, Ispra, VA, Italy.
Elise GrignardDirectorate F-Health, Consumers and Reference Materials, Unit F3 Chemicals Safety and Alternative Methods, European Commission, Joint Research Centre (JRC), Via E. Fermi, 2749. TP126, 21027, Ispra, VA, Italy.
Alicia PainiDirectorate F-Health, Consumers and Reference Materials, Unit F3 Chemicals Safety and Alternative Methods, European Commission, Joint Research Centre (JRC), Via E. Fermi, 2749. TP126, 21027, Ispra, VA, Italy.
Andrew WorthDirectorate F-Health, Consumers and Reference Materials, Unit F3 Chemicals Safety and Alternative Methods, European Commission, Joint Research Centre (JRC), Via E. Fermi, 2749. TP126, 21027, Ispra, VA, Italy.
Anna Bal-PriceDirectorate F-Health, Consumers and Reference Materials, Unit F3 Chemicals Safety and Alternative Methods, European Commission, Joint Research Centre (JRC), Via E. Fermi, 2749. TP126, 21027, Ispra, VA, Italy.
Pilar PrietoDirectorate F-Health, Consumers and Reference Materials, Unit F3 Chemicals Safety and Alternative Methods, European Commission, Joint Research Centre (JRC), Via E. Fermi, 2749. TP126, 21027, Ispra, VA, Italy.
Silvia CasatiDirectorate F-Health, Consumers and Reference Materials, Unit F3 Chemicals Safety and Alternative Methods, European Commission, Joint Research Centre (JRC), Via E. Fermi, 2749. TP126, 21027, Ispra, VA, Italy.
Elisabet BerggrenDirectorate F-Health, Consumers and Reference Materials, Unit F3 Chemicals Safety and Alternative Methods, European Commission, Joint Research Centre (JRC), Via E. Fermi, 2749. TP126, 21027, Ispra, VA, Italy.
Stephanie K BoppDirectorate F-Health, Consumers and Reference Materials, Unit F3 Chemicals Safety and Alternative Methods, European Commission, Joint Research Centre (JRC), Via E. Fermi, 2749. TP126, 21027, Ispra, VA, Italy.
Valérie ZuangDirectorate F-Health, Consumers and Reference Materials, Unit F3 Chemicals Safety and Alternative Methods, European Commission, Joint Research Centre (JRC), Via E. Fermi, 2749. TP126, 21027, Ispra, VA, Italy. valerie.zuang@ec.europa.eu.ORCID http://orcid.org/0000-0003-1302-8769

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The EU Directive 2010/63/EU   on the protection of animals used for scientific purposes and other EU regulations, such as REACH and the Cosmetic Products Regulation advocate for a change in the way toxicity testing is conducted. Whilst the Cosmetic Products Regulation bans animal testing altogether, REACH aims for a progressive shift from in vivo testing towards quantitative in vitro and computational approaches. Several endpoints can already be addressed using non-animal approaches including skin corrosion and irritation, serious eye damage and irritation, skin sensitisation, and mutagenicity and genotoxicity. However, for systemic effects such as acute toxicity, repeated dose toxicity and reproductive and developmental toxicity, evaluation of chemicals under REACH still heavily relies on animal tests. Here we summarise current EU regulatory requirements for the human health assessment of chemicals under REACH and the Cosmetic Products Regulation, considering the more critical endpoints and identifying the main challenges in introducing alternative methods into regulatory testing practice. This supports a recent initiative taken by the International Cooperation on Alternative Test Methods (ICATM) to summarise current regulatory requirements specific for the assessment of chemicals and cosmetic products for several human health-related endpoints, with the aim of comparing different jurisdictions and coordinating the promotion and ultimately the implementation of non-animal approaches worldwide. Recent initiatives undertaken at European level to promote the 3Rs and the use of alternative methods in current regulatory practice are also discussed.

Indexed as

AnimalsAnimal Testing AlternativesCosmeticsEuropean UnionHumansInternational CooperationRisk AssessmentToxicity TestsCosmetics3RsAlternatives to animal testingCosmetic ingredientsCosmetic productsCosmetic products regulationEU regulatory requirementsHuman healthIndustrial chemicalsREACH

Identifiers

PMID33851225
PMCPMC8166712

What OpenQuestion holds

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LicenceCC BY
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.