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CPSR Updates: How Often Should a Cosmetic Product Safety Assessment Be Reviewed?

22 hours ago
9 min read

How often should a CPSR be updated?


“How often should a CPSR be updated?” is a common question among regulatory professionals and cosmetic product safety assessors. The answer cannot be reduced to an annual deadline or a single review interval that applies to every product.


Regulation (EC) No 1223/2009 requires the Cosmetic Product Safety Report (CPSR) to be kept up to date in light of relevant additional information that becomes available after the product has been placed on the market. It does not set a universal CPSR review frequency. The process must therefore identify relevant new information, assess its significance and determine whether it warrants a review of the safety assessment.


What does the EU Cosmetics Regulation require?


Article 10(1)(c) of Regulation (EC) No 1223/2009 specifies that the Responsible Person must ensure that:

“the cosmetic product safety report is kept up to date in view of additional relevant information arising subsequent to placing the cosmetic product on the market.”


Article 11(2) states that “the product information file shall contain the following information and data, updated as appropriate”, including, under point (b), “the cosmetic product safety report referred to in Article 10(1)”. The Regulation therefore provides for updates when necessary, without imposing a universal review frequency applicable to all products.


In practice, companies should establish a documented monitoring and review process suited to their products, ingredients and organisation. A planned periodic review can contribute to this process, but it does not replace the assessment of new information that may affect safety.


What events can trigger a CPSR review?


Several categories of information may lead to a safety assessment being reconsidered. The aim is not to amend every file automatically whenever new information appears, but to assess whether that information is reliable, relevant and likely to affect the conclusions for the product concerned.


Regulatory developments

Some regulatory developments, even when they do not directly concern cosmetics legislation, may warrant further investigation of a substance. An authorisation or restriction under another regulatory framework may be a signal that the available toxicological data should be reviewed. For example, a proposal for, or a new harmonised classification under Annex VI to the CLP Regulation may be accompanied by data relevant to hazard characterisation. It may be appropriate to examine these elements before the classification is formally adopted, taking into account the stage of the process, the robustness of the data and their relevance to cosmetic safety assessment. A regulatory development does not, however, automatically require a toxicological profile or CPSR to be amended.


New toxicological data

New scientific evidence may also justify a review, whether it comes from a study, an assessment report or a scientific opinion. For example, opinions from the European Scientific Committee on Consumer Safety (SCCS) or the US-based Cosmetic Ingredient Review (CIR), including draft or preliminary opinions, may raise questions that warrant examination.

Whether and how they are taken into account depends on the available content, the stage of the process and the strength of the evidence; their publication does not automatically mean that a profile must be amended.


Information from cosmetovigilance

Cosmetovigilance data may reveal a signal concerning a finished product and trigger an investigation, including a review of relevant toxicological literature. Cosmetovigilance is not a COSMETICK feature: it is an external source of information that may lead the teams concerned to reassess relevant knowledge and safety assessments, for example in relation to an ingredient’s skin irritation or skin sensitisation potential.


From new information to an updated toxicological profile


A new publication, scientific opinion or regulatory development does not automatically lead to a change in a toxicological profile. Information must be assessed in terms of reliability, relevance and scientific significance. Depending on the findings, a review may confirm an alert, qualify its significance, add a result that contradicts previous conclusions, expand the available knowledge or refine a toxicological reference value (TRV). The purpose of a review is to reflect the state of knowledge, not to incorporate every new item of information mechanically.


In COSMETICK, a profile review may be considered following relevant regulatory developments, for example, a new harmonised classification, a restriction or a change in the rules applicable to an ingredient, or new toxicological knowledge. An SCCS or CIR opinion, whether in preparation, preliminary or final, may justify reviewing a profile if its content is relevant. Questions raised during safety assessments carried out by CEHTRA toxicologists and Safety Assessors may also prompt further investigation of the available data and a review of a profile.


This approach combines monitoring of published knowledge with practical experience in formula safety assessment. Depending on the evidence reviewed, the process may confirm an alert, reduce the extent of concern, incorporate contradictory findings or refine a toxicological reference value. The decision to amend a profile is based on a scientific assessment of the relevance of the information.


When a profile is updated, what is the impact on existing CPSRs?


Updating a toxicological profile and revising a CPSR are two distinct steps. When a profile changes, it is necessary to determine whether that change has implications for products containing the substance. The assessment must be performed on a case-by-case basis, taking into account the formula, concentration, exposure, conditions of use and conclusions of the original assessment.


When new data do not materially change the conclusions

An update may confirm previous conclusions or provide further detail without materially changing the safety assessment. In that case, an amendment to the CPSR may not necessarily be required; the decision should be based on the relevance of the information to the product concerned.


When a new concern is identified

New data may, for example, suggest a potential for skin sensitisation that had not previously been identified. The emergence of a new concern should trigger a review of potentially affected existing CPSRs, so that its impact on the safety conclusions can be assessed case by case. The analysis should consider the strength and consistency of the evidence, the substance concentration, exposure, conditions of use and the reasoning underpinning the original assessment.


Following this review, the original conclusions may remain valid, further investigations may be needed, or the assessment may have to be revised. The existence of a signal does not, in itself, determine the final conclusion, but it does warrant an assessment of its potential impact.


When a toxicological reference value changes

A new study or reassessment of the available data may justify changing the NOAEL (no-observed-adverse-effect level) used as a reference value. All other things being equal, an increase in the NOAEL may lead to a higher Margin of Safety (MoS), whereas a decrease may reduce the MoS calculated for certain formulas.


A lower NOAEL may therefore prompt a review of the relevant CPSRs to determine whether the margins of safety remain adequate. Conversely, an increase does not remove the need to assess the relevance of the change in the context of the product. In either case, the impact must be assessed in light of all the data and assumptions used in the safety assessment.


COSMETICK provides structured toxicological profiles and tools to support formula safety assessment. Any statement about impact analysis functionality or the automatic identification of affected CPSRs must be aligned precisely with the functions actually available in the version of the tool shown to users.


Figures illustrating profile updates in COSMETICK


In 2025, 60% of the toxicological profiles CEHTRA toxicologists worked on were updates to existing profiles. In 2026, this proportion reached 70%. This figure represents the share of profiles handled during the year that were updates, not the proportion of the entire database that was updated during the year.


COSMETICK provides access to more than 5,200 toxicological profiles, over 70% of which relate to cosmetic ingredients, as well as more than 2,600 ecotoxicological profiles. In 2026, the average time required to create a new toxicological profile was eight days, according to indicators provided by CEHTRA. The reference period and calculation method for this indicator should be confirmed before publication.


The increase from 60% to 70% illustrates the growing role of updating existing profiles in CEHTRA’s scientific work, alongside the creation of new profiles. It reflects the need to take account of new scientific data, regulatory developments and questions raised during safety assessments.


Examples of toxicological profile updates


Phenethyl benzoate: a new warning highlighting a potential skin sensitisation concern

The toxicological profile for PHENETHYL BENZOATE (CAS No. 94-47-3) was enhanced with the addition of an “Allergy” warning following the identification of relevant information in the Assessment of Regulatory Needs report published by the European Chemicals Agency (ECHA) in 2026.


In this report, phenethyl benzoate is included in the “Benzoates” group, which is considered to present a known or potential skin sensitisation hazard. However, ECHA indicates that no EU-wide Risk Management Measure (RRM) is currently considered necessary. Adding this warning in COSMETICK makes the point of concern visible to users. When assessing a formula containing this ingredient, users can identify the signal directly in the formula analysis table and then consult the toxicological profile for further information.


This example illustrates how a profile update can make a relevant scientific or regulatory signal visible even when it does not lead to a new regulatory restriction. The warning is a point for the assessor to consider; it is not proof that an allergic reaction will occur under the product’s conditions of use.


Bakuchiol: making a regulatory foresight signal visible during formula assessment

When the toxicological profile for BAKUCHIOL (CAS No. 10309-37-2) was updated in 2023 to incorporate information from the Assessment of Regulatory Needs report published by the European Chemicals Agency (ECHA), a new point of concern was added.


In the report, bakuchiol is included in the “4-Hydrocarbylphenols (other than styrenated phenols)” group, identified as presenting a known or potential endocrine-disrupting hazard. The report considers possible identification as a Substance of Very High Concern (SVHC) and/or harmonised classification and labelling (CLH), potentially followed by a restriction if the hazards are confirmed. This is an early regulatory signal based on a toxicological concern. It is intended to prompt the safety assessor to exercise vigilance and supports CEHTRA’s ongoing profile review work; it is not confirmation of a hazard or evidence that a restriction has been adopted.


In COSMETICK, this information is incorporated into the toxicological profile as a colour-coded tag. When a formula containing bakuchiol is assessed, the corresponding warning also appears on the ingredient row in the formula analysis table. Users can therefore identify the issue directly in their analysis and consult the toxicological profile to examine the available information. This connection between the scientific profile and warnings makes points requiring attention visible and helps toxicologists determine whether further investigation may be needed.


Pentylene glycol: new data help complete the assessment of developmental toxicity

The toxicological profile for PENTYLENE GLYCOL (CAS No. 5343-92-0) was updated following the integration of new studies conducted on the substance itself as part of its REACH registration dossier. These studies include studies performed in accordance with OECD Test Guidelines TG 471, TG 421, TG 443 and TG 414. Previously, the profile relied in part on read-across data from 1,2-butanediol and 1,2-hexanediol. Incorporating new data specific to pentylene glycol made it possible to remove these indirect data and address a data gap relating to reproductive and developmental toxicity.


The objective was not simply to increase the amount of available data, but to complete the assessment of an essential aspect of safety: potential effects on the development of the unborn child. The dossier now contains data needed to cover this aspect of the toxicological assessment, which had not previously been documented sufficiently.


This example illustrates how updating a toxicological profile can address a scientific data gap and broaden the range of effects that can be assessed using substance-specific data rather than data obtained by analogy with other substances.


Florazon: refining the irritation potential based on human data

The toxicological profile for Florazon (INCI: ETHYL 2,2-DIMETHYLHYDROCINNAMAL), a fragrance ingredient, was updated using data from the scientific literature. This review helped refine its irritation potential and identified a concentration of 3% as non-irritating in a human patch test, according to the RIFM Fragrance Raw Materials Monographs.

This example illustrates the value of reviewing scientific data: updating a profile does not only involve adding new alerts or changing toxicological reference values. It can also improve the characterisation of a local effect and clarify results observed under a specific test protocol.


Establishing an ongoing safety monitoring process

Keeping safety assessments up to date requires an organised process: monitor relevant information, assess its scientific significance, update profiles when justified, and then examine the potential impact on the assessments of the products concerned.


CEHTRA WATCH can support the monitoring of scientific and regulatory developments that may warrant investigation. COSMETICK provides structured, regularly reviewed toxicological profiles and tools to support formula safety assessment. The two solutions are complementary: CEHTRA WATCH helps identify relevant information, while COSMETICK supports the review of toxicological knowledge and formula assessment.


The aim is not to revise every CPSR automatically whenever a new publication appears. It is to establish a traceable process for determining which information matters, which assessments may be affected and what action is needed.


Conclusion

Updating a safety assessment or CPSR is not a matter of following a fixed schedule. The EU Cosmetics Regulation requires the report to be kept up to date in view of relevant additional information arising after the product has been placed on the market. In practice, this means identifying new information, assessing its scientific significance and determining whether the safety conclusions remain valid for the product concerned.


By combining regularly reviewed toxicological profiles with tools that support formula safety assessment, COSMETICK helps support this work. Keeping toxicological knowledge up to date is not simply about adding data: it also means critically reviewing the evidence, understanding its implications and assessing its potential impact on product safety.


Regulatory references and useful links

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