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Out of REACH: environmental hazards of cosmetic

preservatives

Diana Kättström, Anna Beronius, Urban Boije af Gennäs, Christina Rudén &
Marlene Ågerstrand

To cite this article: Diana Kättström, Anna Beronius, Urban Boije af Gennäs, Christina Rudén
& Marlene Ågerstrand (06 Jan 2024): Out of REACH: environmental hazards of cosmetic
preservatives, Human and Ecological Risk Assessment: An International Journal, DOI:
10.1080/10807039.2023.2301073

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HUMAN AND ECOLOGICAL RISK ASSESSMENT: AN INTERNATIONAL JOURNAL
https://doi.org/10.1080/10807039.2023.2301073

Out of REACH: environmental hazards of cosmetic

preservatives
€ma, Anna Beroniusb, Urban Boije af Genn€asc, Christina Rud�ena, and
Diana K€attstro
Marlene Ågerstranda
a
Department of Environmental Science, Stockholm University, Stockholm, Sweden; bInstitute of
Environmental Medicine, Karolinska Institutet, Solna, Sweden; cSwedish Chemicals Agency, Sundbyberg,
Sweden

ABSTRACT ARTICLE HISTORY

The EU Cosmetic Products Regulation requires neither environmental Received 5 September 2023
data nor environmental risk assessment for individual ingredients or Accepted 10 December 2023
finished cosmetic products. Instead, it relies on REACH to address
KEYWORDS
environmental risks linked to cosmetic ingredients, including preserva­
CLP; REACH; cosmetic
tives. We investigated how the environmental risks of cosmetic preser­ preservatives; environmental
vatives are managed by REACH. We identified preservatives of hazards; one substance –
environmental concern and examined if any of these had been one assessment
selected for Substance Evaluation, proposed for or identified as an
SVHC, required authorization or were proposed for, or subject to,
restriction under REACH. More than half of the preservatives approved
under the Cosmetic Product Regulation, 70 of 137, were identified as
being of environmental concern according to the criteria set in this
study. Some of the approved preservatives were no longer produced
or used in the EU due to their hazardous properties. However, they
remained approved and may still enter the EU via the imported prod­
ucts. Our results also indicate that the environmental aspects of cos­
metic ingredients, including preservatives, are not efficiently managed
by REACH. Besides the known issues in REACH, we identified add­
itional areas in the interface between REACH, CLP and the Cosmetic
Products Regulation that call for improvement. Here, we provide prac­
tical suggestions in line with the Chemicals Strategy for Sustainability.
If implemented, these measures would strengthen the protection of
the environment from hazardous cosmetic ingredients.

Introduction
In 2020, the European Commission introduced the Chemicals Strategy for Sustainability,
an ambitious plan toward a toxic-free environment ([EC] European Commission 2020).
One of the specific aims of the strategy is to strengthen the EU chemicals legislation to
better protect human health and the environment. To achieve that, the Commission pro­
posed a line of measures, including strengthening requirements across legislations to

CONTACT Diana K€attstr€ om diana.kattstrom@aces.su.se Department of Environmental Science, Stockholm

University, Svante Arrhenius v€ag 8, 106 91 Stockholm, Sweden.
Supplemental data for this article can be accessed online at https://doi.org/10.1080/10807039.2023.2301073.
� 2024 The Author(s). Published with license by Taylor & Francis Group, LLC
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/
licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly
cited. The terms on which this article has been published allow the posting of the Accepted Manuscript in a repository by the author(s)
or with their consent.
2 D. KÄTTSTRÖM ET AL.

enable comprehensive environmental risk assessment and addressing regulatory inconsis­

tencies between the different pieces of chemicals legislation through a “one substance,
one assessment” approach (EC 2020). One such inconsistency concerns substances used
as ingredients in cosmetic products and their environmental impact (EC 2019).
Cosmetic products are everyday chemical mixtures for consumer use, such as tooth­
paste, soaps, shampoos, perfumes, and make-up. In the EU, cosmetic products are regu­
lated by a product-specific regulation, the Cosmetic Products Regulation (EC) 1223/
2009 ([EPCEU] European Parliament and Council of the European Union 2009). In
addition, the substances contained in cosmetic products fall under the two overarching
chemicals regulations: Regulation (EC) 1907/2006 concerning the Registration,
Evaluation, Authorization and Restriction of Chemicals (REACH) and Regulation (EC)
1272/2008 on Classification, Labeling and Packaging (CLP). More detailed information
about REACH, the CLP, and their processes is available in Supplementary materials.
The Cosmetic Products Regulation applies to finished cosmetic products and aims at
ensuring their safety for human health. This is achieved through a general prohibition
of the use of substances with carcinogenic, mutagenic, or reprotoxic (CMR) properties
in cosmetic products. Further, the use of other substances harmful to human health
may be restricted or prohibited under Annex II and III to the Cosmetic Products
Regulation. In addition, cosmetic ingredients used as UV filters, colorants, and preserva­
tives require a safety assessment by the Scientific Committee for Consumer Safety
(SCCS) and approval by the European Commission. Only the approved UV filters, colo­
rants, and preservatives may be used in cosmetic products. The safety of the remaining
ingredients is evaluated together with the safety of the finished product by the manufac­
turers or distributors in a so-called cosmetic product safety report. The report includes
information about the composition of the product, intended uses, exposure assessment,
and toxicological information on the ingredients. The report is not reviewed by, or sub­
mitted to, the authorities but should be made available upon request (EPCEU 2009).
The above measures only focus on the protection of human health. The Cosmetic
Products Regulation requires neither environmental data nor environmental risk assess­
ment for individual ingredients or finished products (EPCEU 2009). For example, pres­
ervatives, i.e. substances with antimicrobial properties used to prolong the shelf-life of
finished cosmetic products, are not evaluated for their environmental properties
(EPCEU 2009; EC 2018, 2023). This is despite their potential to negatively impact
aquatic systems if emitted into the environment via the wastewater (Nowak-Lange et al.
2022; Vale et al. 2022). Cosmetic preservatives specifically, have been implicated in
being able to affect the aquatic environment and contributing to the development of
antimicrobial resistance (Romero et al. 2017). In the EU, the environmental hazards of
cosmetic ingredients, including preservatives, should be considered through REACH
(EPCEU 2009). To identify environmentally hazardous substances, REACH (EPCEU
2006) provides criteria for persistent, bioaccumulative and toxic (PBT) and very persist­
ent, very bioaccumulative (vPvB) properties. Substances identified as PBT/vPvB may be
selected for Substance Evaluation to clarify whether or not the risks connected to their
use are adequately managed. If risk management measures are required, the substance
may be identified as a Substance of Very High Concern (SVHC), included on the
Candidate List for Authorization, and potentially also on the Authorization List or
 HUMAN AND ECOLOGICAL RISK ASSESSMENT: AN INTERNATIONAL JOURNAL 3

restricted (EPCEU 2006). However, a PBT/vPvB assessment is only performed for sub­
stances produced/imported in quantities of 10 tonnes or more per registrant and year
(EPCEU 2006), which means that substances with potential PBT/vPvB properties in
quantities under that limit may remain unidentified.
Classification under the CLP Regulation provides another option to identify environ­
mentally hazardous substances as it sets criteria for substances hazardous to the aquatic
environment i.e. Aquatic Acute and Aquatic Chronic (EPCEU 2008). REACH is closely
interlinked with the CLP Regulation and risk management tools available under
REACH often rely on classifications under the CLP. However, the regulatory obligations
under REACH for substances classified as Aquatic Acute/Aquatic Chronic under the
CLP Regulation are limited to requirements of additional information and inclusion of
exposure assessment and risk characterization into the chemical safety assessment
(EPCEU 2006). Recently, our new hazard classes were added to the CLP, three of which
are environmental. The European Commission is planning to revise REACH to include
new data requirements and regulatory obligations to facilitate classification of substances
into the new hazard classes and ensure their proper regulation (EC 2020). At the time
of writing, no timeline for the revision is available.
Since the Cosmetic Products Regulation does not consider the environmental impact
of the ingredients or finished products, remitting the management of the environmental
hazards to REACH has been identified as a regulatory inconsistency in the fitness check
carried out by the European Commission (EC 2019). However, according to the fitness
check report, the practical significance of this regulatory inconsistency was not possible
to determine due to insufficient input from the stakeholders (EC 2019). The aim of this
study was to investigate how environmental hazards associated with cosmetic preserva­
tives are managed under REACH. To explore this, we investigated if any of the
approved cosmetic preservatives were of environmental concern and if so, whether or
not they were subjected to Substance Evaluation, SVHC identification, Authorization
and Restriction.

Method
Selection of substances
Annex V to the Cosmetic Products Regulation lists all approved cosmetic preservatives
and constitutes the scope of substances included in this analysis. An entry in Annex V
may contain one or more unique substances. For this study, all substances with unique
EC and CAS numbers are regarded as separate, approved cosmetic preservatives, further
referred to as cosmetic preservatives.

Data sources and data collection

The European Chemicals Agency’s database was used as the data source (available from:
https://echa.europa.eu/sv/information-on-chemicals). The search and data collection was
performed using substance identifiers i.e., EC and CAS numbers. The following infor­
mation was collected for all substances: REACH registration status and tonnage, classifi­
cation for environmental (aquatic) hazards according to the CLP Regulation, the
4 D. KÄTTSTRÖM ET AL.

outcome of the PBT assessment, and the results of the biodegradation screening test in
water under REACH. In addition, it was checked whether the cosmetic preservatives
had been subjected to Substance Evaluation, identified as an SVHC, or a candidate for
authorization or restriction under REACH. All information was organized in an Excel
database. The data sources and the type of data collected are presented in Table 1. Data
were accessed from May 2022 to September 2022.

Data analysis: identification of cosmetic preservatives of environmental concern

and their risk management under REACH
The analysis proceeded in two steps. First, cosmetic preservatives hazardous to the
environment were identified. For the purpose of this study, we refer to these substances
as cosmetic preservatives of environmental concern. A preservative was considered to
be of environmental concern if it fulfilled any of the following criteria:

� Classified as Aquatic Acute or Aquatic Chronic of any category under the CLP
Regulation by self-classification or harmonized classification
� Determined to fulfill the criterion for P in the PBT assessment performed as part
of the Chemical Safety Assessment for substances in quantities above 10 tonnes
per year under REACH

Table 1. Data sources and type of data collected from the European Chemicals Agency’s database.
Data source
Annex V to the Cosmetic Products Regulation (EC) 1223/
2009 – approved cosmetic preservatives
C&L Inventory
REACH Substance Brief Profile
REACH registered substance factsheet
Community rolling action plan (CoRAP) list
Registry of restriction intentions until outcome
Annex XVII to REACH - list of substances subject to
authorization
Registry of SVHC intentions until outcome
Candidate List of substances of very high concern for
authorization
Annex XIV to REACH - restrictions on the manufacture,
placing on the market and use of certain dangerous
substances, mixtures and articles
Type of data collected
Name, EC and CAS number of all approved cosmetic
preservatives
Environmental hazard classification as Aquatic Acute
category 1 and/or Aquatic Chronic category 1, 2, 3 or
4 under the CLP Regulation (self-classification by at
least one notifier or harmonized classification) for all
identified preservatives. If a substance were classified
in more than one category, the highest classification
was chosen.
Registration status and annual tonnage reported in the
registration dossier under REACH
Outcome of the PBT assessment, outcome of the
biodegradation screening tests in water
Reason for inclusion and the outcome of the process of
substances that have been or will be evaluated by
ECHA under the process of Substances Evaluation
under REACH
Reason for inclusion and the outcome of the process of
substances that have been proposed for restriction
under REACH
Reason for inclusion and the outcome of the process of
substances restricted under REACH
Reason for inclusion and the outcome of the process of
substances that have been proposed for identification
as SVHC under REACH
Reason for inclusion and the outcome of the process of
substances identified as SVHC under REACH
Reason for inclusion and the outcome of the process of
substances that require aunder REACH
 HUMAN AND ECOLOGICAL RISK ASSESSMENT: AN INTERNATIONAL JOURNAL 5

� Determined to be not biodegradable in screening tests for biodegradation in

water submitted as part of the REACH dossier. Preservatives for which the
results of the ready biodegradation test concluded “under test conditions no bio­
degradation observed” were regarded as potentially persistent

The criteria were chosen based on available information under the CLP and REACH.
CLP identifies substances classified as Aquatic Acute and/or Aquatic Chronic as hazard­
ous to the environment. REACH mandates PBT assessment for substances in quantities
above 10 tonnes per year. However, persistence alone has important implications for
the behavior of chemicals in the environment (Cousins et al. 2019). Therefore, substan­
ces meeting the persistence (P) criteria in Annex XIII of REACH were considered to be
of environmental concern. In the absence of a full PBT assessment, a ’no biodegradation
observed’ result in the ready biodegradation test, submitted in the REACH dossier, was
considered as sufficient indication of persistence.
Next, for the identified cosmetic preservatives of environmental concern, we exam­
ined if they had been selected for Substance Evaluation, proposed for or identified as an
SVHC, required authorization or were proposed for, or subject to, restriction. If so, we
considered the justification for, and the regulatory outcome of the inclusion and/or
assessment.

Results
Identifying cosmetic preservatives of environmental concern
In total, Annex V of the Cosmetic Products Regulation lists 137 unique, approved, cos­
metic preservatives. For a full list see Supplementary Table 5. More than half of the
approved cosmetic preservatives, 70 of 137, were identified as being of environmental
concern (Figure 1). Of these, 13 fulfilled both the criteria for hazardous to the aquatic
environment and persistency/potential persistency criteria, 56 only fulfilled the criterion
for aquatic hazard, and one only fulfilled the criterion for persistency/potential
persistency.

Registration status and tonnages under REACH

Figure 2 shows the registration status and tonnages of the cosmetic preservatives of
environmental concern. Among the 70 cosmetic preservatives of environmental concern,
21 substances were not registered under REACH and thus had no regulatory obligations
to provide data or perform an assessment. Since a REACH registration is required for
all chemical substances produced or imported in annual quantities of one tonne and
above per registrant (EPCEU 2006), it can be assumed that the annual quantities of
these substances are below one tonne per registrant. Five of the 70 substances did not
have any obligations under REACH. One was due to it being registered for intermediate
use only and four due to ceased production. Further, six cosmetic preservatives of con­
cern were registered at annual tonnages of less than 10 tonnes per year. For these sub­
stances, the PBT assessment was not required.
6 D. KÄTTSTRÖM ET AL.

Figure 1. The number of cosmetic preservatives that are not considered to be of concern (n ¼ 67)
and those that fulfill at least one criterion as defined in this study to be considered of environmental
concern (n ¼ 70) of the total number of cosmetic preservatives (n ¼ 137). Cosmetic preservatives of
environmental concern are comprised of 56 substances that fulfill the criterion of hazardous to the
aquatic environment, 1 substance that fulfilled the criterion for persistency or potential persistency,
and 13 that fulfilled both of the criteria. More details are available from the Supplementary Table 4.

Figure 2. REACH registration status and total annual tonnage data for the 70 cosmetic preservatives
identified as cosmetic preservatives of environmental concern according to the criteria set in this study.

The remaining 38 substances were produced/imported at 10 tonnes or more per year

and were subject to PBT assessment. The PBT assessment was not available for eight of
the 38 substances, in four cases due to substances being inorganic and thus being
 HUMAN AND ECOLOGICAL RISK ASSESSMENT: AN INTERNATIONAL JOURNAL 7

exempted from the requirement. In the four remaining cases, the reason for not submit­
ting a PBT assessment was not clear to us.

Substance evaluation under REACH

Among the 49 cosmetic preservatives of environmental concern registered under
REACH, six were subjects to Substance Evaluation and are further described below and
in Table 2. Among those six, three were prioritized for substance evaluation based on
environmental concerns as well as human health concerns and one substance was pri­
oritized based on environmental concerns only.
Sodium metabisulphite (EC# 231-673-0, CAS# 7681-57-4) was evaluated in 2014 for
the concerns of being CMR, exposure to the environment, exposure of sensitive popula­
tions, high aggregated tonnage and wide dispersive use. The Substance Evaluation report
concluded that, based on the available hazard data, the substance was not of concern to
the environment, and that no further investigation was necessary. The evaluation was
concluded with the recommendation for harmonized classification under the CLP
Regulations as STOT SE (Specific target organ toxicity, single exposure) category 3 for
respiratory tract irritation based on acute toxicity data (Hungarian National Institute of
Chemical Safety 2015).
The evaluation for Methylparaben (EC# 202-785-7, CAS# 99-76-3) started in 2014
with the initial ground for concern including being CMR, potential endocrine disruptor,
being used in consumer products, exposure of sensitive populations, high aggregated
tonnage and wide dispersive use. The evaluating Member State Competent Authority
has requested further information before a conclusion could be made ([ECHA]
European Chemicals Agency 2016c). No conclusion has yet been made.
1-(4-Chlorophenyl)-3-(3,4-dichlorophenyl) urea, also called Triclocarban (EC# 202-
924-1, CAS# 101-20-2), was subjected to Substance Evaluation in 2019. The justification
included suspected reprotoxic and endocrine disrupting properties and wide dispersive
use. In addition to the above, the Substance Evaluation report ([ANSES] French Agency
for Food Environmental and Occupational Health and Safety 2020) lists microbial
resistance and non-approved use as a biocide as additional concerns that required inves­
tigation. The report concluded the need for updating the harmonized classification
under the CLP with Reprotoxic, based on effects on fertility and developmental effects
via lactation. Since there are currently no active registrants, all further follow-up actions
have been halted (ANSES 2020).
5-Chloro-2-(2,4-dichlorophenoxy) phenol, also called triclosan (EC# 222-182-2,
CAS# 3380-34-5) was evaluated in 2012 based on concerns of being a potential endo­
crine disruptor, suspected PBT/vPvB and high aggregated tonnage. The evaluation
resulted in a request for more information (ECHA 2014) which was later partially
annulled by the Board of Appeal of the European Chemicals Agency (ECHA 2016a).
No conclusion has yet been made.
1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one, also known as
climbazole (EC# 253-775-4, CAS# 38083-17-9) was evaluated in 2014 based on con­
cerns of being CMR, being used in consumer products and wide dispersive use. The
evaluation resulted in a request for additional information (ECHA 2016b) which was
 8

Table 2. Approved cosmetic preservatives subjected to Substance Evaluation under REACH, the initial grounds for concern, and the outcome of the
process.
Environmental hazard
classification under the
Annual tonnage CLP(S) self-classification, (H) Biodegradation in water - Assessment of the P
(tonnes per year) harmonized screening tests reported criterion reported in the PBT Year of evaluation and
Substance identity reported under REACH classification Under REACH assessment under REACH Initial grounds for concern Status and outcome
Sodium metabisulfite �100 000 to (S) Aquatic Chronic 3 Not applicable (inorganic) Not applicable 2014 Concluded: Suggested
EC# 231-673-0 <1 000 000 (inorganic) Suspected CMR harmonized classification
D. KÄTTSTRÖM ET AL.

CAS# 7681-57-4 Exposure of environment and labeling under

Exposure of sensitive the CLP
populations
High (aggregated) tonnage
Wide dispersive use
Methylparaben �100 to <1000 (S) Aquatic Chronic 2 Readily biodegradable Not P/vP 2014 Information requested
EC# 202-785-7 CMR
CAS# 99-76-3 Potential endocrine
disruptor
Consumer use
Exposure of sensitive
populations
High (aggregated) tonnage
Wide dispersive use
1-(4-Chlorophenyl)-3-(3,4- Not currently (S) Aquatic Acute 1 Readily biodegradable P 2014 Concluded: Evaluation
dichlorophenyl) urea manufactured (S) Aquatic Chronic 1 Suspected Reprotoxic terminated with the
EC# 202-924-1 Potential endocrine open concern due to
CAS# 101-20-2 disruptor lack of active registrants
Wide dispersive use
5-Chloro-2-(2,4- Not currently (H) Aquatic Acute 1 Inherently biodegradable Not P/vP 2019 Follow-up: Information
dichlorophenoxy) phenol manufactured (H) Aquatic Chronic 1 Potential endocrine requested
EC# 222-182-2 disruptor
CAS# 3380-34-5 Suspected PBT/vPvB
High (aggregated) tonnage
1-(4-Chlorophenoxy)-1- �10 to <100 (S) Aquatic Acute 1 Under test conditions no vP 2012 Follow-up: Information
(imidazol-1-yl)-3,3- (S) Aquatic Chronic 1 biodegradation observed Suspected CMR requested
dimethylbutan-2-one Consumer use
(climbazole) Wide dispersive use
EC# 253-775-4
CAS# 38083-17-9
Steartrimonium chloride �100 to <1000 (S) Aquatic Acute 1 Readily biodegradable Not P/vP 2018 Withdrawn, concerns
EC# 203-929-1 (S) Aquatic Chronic 1 Suspected PBT/vPvB resolved
CAS# 112-03-8 Exposure of environment
Wide dispersive use
 HUMAN AND ECOLOGICAL RISK ASSESSMENT: AN INTERNATIONAL JOURNAL 9

partially annulled by the Board of Appeal of the European Chemicals Agency (ECHA
2018) with some information requirements still pending (ECHA 2019).
Steartrimonium chloride (EC# 203-929-1, CAS# 112-03-8) was elected for the
Substance Evaluation in 2018 based on concerns of being PBT/vPvB, exposure to the
environment and wide dispersive use (Istituto Superiore di Sanit�a 2018) but later with­
drawn (Istituto Superiore di Sanit�a 2019). The withdrawal was a result of a conclusion
by the European Chemicals Agency that several quaternary ammonium compounds,
including steartrimonium chloride, were not PBT (Istituto Superiore di Sanit�a 2019)
(Table 2).

Substances of very high concern and the Candidate List for Authorization
Two of the cosmetic preservatives have been identified as SVHCs and included in the
Candidate List for Authorization. Both substances were identified as SVHCs on the
basis of human health concerns following REACH article 57(f) (Table 3).
Gularaldehyde, also known as glutaral (EC# 203-856-5, CAS# 111-30-8) was
included on the Candidate List for Authorization in 2021 due to its respiratory-sensitiz­
ing properties (ECHA 2021a). It was proposed to be included in the Authorization List
(ECHA 2023a) and currently awaits a decision.
Butyl 4-hydroxybenzoate (EC# 202-318-7, CAS# 94-26-8) was included on the
Candidate List for Authorization in 2020 due to its endocrine-disrupting properties
(ECHA 2020). As of August 2023, the substance has not been recommended for inclu­
sion in the Authorization List.

Restriction under REACH

One approved cosmetic preservative has been restricted under REACH, although it does
not have an active registration. The decision on the restriction of phenylmercury acetate
(EC#200-532-5, CAS# 62-38-4) was made in 2012 and entered into force in October
2017 (EC 2012). The restriction was a consequence of the Community Strategy

Table 3. Cosmetic preservatives of environmental concern identified as substances of very high con­
cern (SVHCs) under REACH, their environmental classification under the CLP Regulation, as well as
justification for inclusion in the Candidate List for Authorization.
Justification for
Biodegradation in Assessment of the P identification as
Substance identity Environmental hazard water - screening criterion reported in SVHC and inclusion
(name, EC number, classification tests reported Under the PBT assessment in the Candidate List
and CAS number) under CLP REACH under REACH for Authorization
Glutaraldehyde; (H) Aquatic Acute 1 Readily Not P/vP Respiratory
Pentane-1,5-dial (H) Aquatic Chronic 2 biodegradable sensitizing
EC# 203-856-5 properties (Article
CAS# 111-30-8 57(f) - human
health)
Butyl 4- (S) Aquatic Chronic 3 Readily Not required (low Endocrine disrupting
hydroxybenzoate (S) Aquatic Chronic 4 biodegradable tonnage) properties (Article
57(f) - human
EC# 202-318-7 health)
CAS# 94-26-8
10 D. KÄTTSTRÖM ET AL.

Concerning Mercury which communicated the need to reduce the levels of mercury in
the environment and lower human exposure due to the risks that it poses to human
health and the environment (EC 2012). The restriction covered the production, placing
on the market, and use of phenylmercury as a substance or in mixtures and articles
where the concentration of mercury is equal to or greater than 0.01% by weight (EC
2012). Regulation (EU) 2017/852 on mercury prohibits several uses of mercury, includ­
ing the use in cosmetic products other than as a preservative following the conditions
laid down by Annex V to the Cosmetic Products Regulation (EPCEU 2017).
According to Annex V to the Cosmetic Products Regulation, the use of phenylmer­
cury acetate and two other mercury-containing preservatives, thiomersal (CAS# 54-64-8,
EC# 200-210-4) and phenylmercury benzoate (CAS# 94-43-9, EC# 202-331-8), is
allowed in eye products with a maximum concentration of 0.007% for mercury in the
final product (EPCEU 2009). This means that these substances may continue to be used
in cosmetic products since the maximum allowed concentration in the finished product
is below the threshold of the restriction under REACH, and due to the exemption from
Regulation (EU) 2017/852 on mercury.

Discussion
Environmental risks of cosmetic products or their ingredients are neither assessed or
managed under the Cosmetic Products Regulation. Instead, these risks should be con­
sidered through REACH. This study aimed to investigate how REACH manages the
environmental hazards of the cosmetic preservatives approved under the Cosmetic
Products Regulation. The results showed that more than half of the approved cosmetic
preservatives were of environmental concern i.e., classified as toxic to the aquatic envir­
onment according to the CLP Regulation and/or persistent or potentially persistent
according to REACH. This indicates that environmentally hazardous substances may be
present in cosmetic products and justifies the need for environmental risk assessment
and management to protect the environment.
Substances evaluated under the Substance Evaluation, identified as SVHCs, as well as
substances restricted under REACH were also found among the identified cosmetic
preservatives of environmental concern. Moreover, one-third of all cosmetic preserva­
tives of environmental concern were not registered under REACH. Based on our results,
no clear conclusion could be drawn on the effectiveness of REACH in managing the
environmental concerns of cosmetic preservatives. However, our study highlighted sev­
eral issues regarding the interlinkage between the CLP Regulation, REACH, and the
Cosmetic Products Regulation, which may affect the management of cosmetic preserva­
tives of environmental concern.
The presence of a substance on the list of approved cosmetic preservatives is not
indicative of the actual use of that substance. One in three preservatives of environmen­
tal concern was not registered under REACH, possibly due to the ceased or low produc­
tion or import. However, keeping substances that are no longer produced or used on
the list of approved cosmetic preservatives, is not desirable as this allows for import of
products containing these substances into the EU. As an example, triclosan, an
approved cosmetic preservative, is widely known for its negative effects on the
 HUMAN AND ECOLOGICAL RISK ASSESSMENT: AN INTERNATIONAL JOURNAL 11

environment and its ability to contribute to the development of antimicrobial resistance

(Carey and McNamara 2014; Lu et al. 2018; Li et al. 2019). Currently, triclosan is no
longer produced or imported into the EU, which might have halted the ongoing regula­
tory efforts, such as its assessment for PBT and endocrine disruptive properties (ECHA
2023b). Yet, since the substance remains on the list of approved preservatives, cosmetic
products containing triclosan are still allowed to be imported into the EU and placed
on the market. The approval of cosmetic preservatives is not legally required to be
reevaluated at any regular time interval, and the approval of cosmetic preservatives is
not time-limited (EPCEU 2009). This may enable substances like triclosan to remain an
approved preservative in cosmetic products despite it being identified as having
unacceptable properties under other assessment processes.
The REACH and CLP Regulations are central pillars of the chemicals legislation in
the EU. However, for environmentally hazardous substances, the interlinkage between
the two regulations is incomplete. Since the CLP Regulation itself does not place any
regulatory obligations on the classified substances, any risk management measures will
depend on other regulations, such as REACH. Under the CLP Regulation, substances
that fulfill the criteria for classification as Aquatic Acute/Aquatic Chronic are considered
to be environmentally hazardous. Meanwhile, classification as toxic to the aquatic envir­
onment under the CLP Regulation on its own is not enough to trigger Substance
Evaluation, identification as SVHC, Authorization or Restriction under REACH. The
regulatory obligations and risk management measures related to the environment under
REACH are triggered only by fulfilling the criteria for PBT/vPvB.
According to the PBT criteria under REACH, the criterion for toxicity (T) may be
fulfilled if a substance is hazardous to human health or the environment. For human
health hazards, the criterion for toxicity refers to the CLP classification. Thus, the criter­
ion for toxicity (T) is fulfilled if a substance is classified as carcinogenic, mutagenic,
reprotoxic or toxic to specific target organ after repeated exposure (STOT RE) under
the CLP Regulation. For the environmental hazard, however, the criterion does not refer
to the CLP classification. Instead, the criterion is set as long-term no-observed effect
concentration (NOEC) or effect concentration (EC10) of less than 0.01 mg/L. The rea­
son for such a difference may lie in the way the criteria for aquatic toxicity under the
CLP regulation is set. Under the CLP, the criteria incorporate the degradation proper­
ties of the substance. For example, a rapidly degradable substance with NOEC/EC10 of
less than 0.01 mg/L may be classified as Aquatic Chronic category 1. However, a non-
degradable substance with NOEC/EC10 of 0.1 mg/L may also be classified as Aquatic
Chronic category 1. This means that for environmentally hazardous substances, the CLP
classification may not automatically be considered as meeting the criterion for T in a
PBT assessment.
Consequently, the above may lead to environmental risks connected to substances
classified as hazardous to the aquatic environment under the CLP which might be over­
looked under REACH. This might especially be the case for substances below 10 tonnes
per year, for which PBT assessment is not required. Furthermore, the fact that the
environmental classification under the CLP is inadequate for meeting the toxicity criter­
ion (T) in PBT assessment under REACH, puts additional burden on the producers/
importers of chemicals to perform two separate assessments.
12 D. KÄTTSTRÖM ET AL.

Additionally, REACH has several known issues that may slow down the regulation of
hazardous chemicals. For example, the limited requirements for environmental data for
substances in tonnages below 100 tonnes per year have been previously described
(Ruden and Hansson 2010). In 2021, the European Chemicals Agency published a
report on the operation of the REACH and CLP Regulations (ECHA 2021b). The report
described several issues concerning the operation and effectiveness of the REACH risk
management measures. For example, the request for more information under the
Substance Evaluation can only be made if the potential risk of the substance can be
demonstrated based on information available in the submitted dossier. This means that
it might be difficult to justify the request for more data for substances with lower
annual tonnages, for which limited data is required under REACH. Further, it has to be
clear that the concerns are severe enough to justify the need for clarification and more
information. Finally, there has to be a realistic possibility that the request for informa­
tion and the clarification of the concerns will lead to improved risk management. The
combination of limited hazard information for substances in lower quantities and the
difficulties of justifying the request for more, result in low effectiveness of the Substance
Evaluation process (ECHA 2021b). The report also pointed out the slowness in the
identification of SVHCs, authorization and restriction processes, and the low number of
substances subject to risk management measures (ECHA 2021b).
Recently, as part of the Chemical Strategy for Sustainability, new hazard classes have
been added to the CLP Regulation, three of which concern the environment (EC 2022).
The new hazard classes provide criteria for substances with PBT/vPvB, persistent,
mobile and toxic (PMT), very persistent and very mobile (vPvM), and endocrine dis­
ruptive properties for the environment (ED ENV). This measure, together with the fore­
seen revision of REACH, may improve the interlinkage between the CLP and REACH
and allow for a more harmonized approach toward environmentally hazardous substan­
ces. However, to ensure the safety of the cosmetic ingredients to the environment, fur­
ther measures might be necessary.
First, the current prohibition of the use of CMR substances under the Cosmetic
Products Regulation should be expanded to include the new hazard classes for PBT/
vPvB, PMT/vPvM and endocrine disruptors in the environment. This measure would
allow the use of all available hazard data, including already existing animal data, despite
the ban on the use of animal data under the Cosmetic Products Regulation. This would
be in line with the ambition of the Chemical Strategy for Sustainability to transform the
CLP Regulation into the central piece of the EU chemicals legislation.
Further, we suggest removing cosmetic products as an exemption from the CLP
Regulation’s obligation to classify mixtures. This would mean that environmentally haz­
ardous cosmetic products would be labeled with hazard pictograms, similar to many
other types of mixtures. In turn, this would allow the consumers to make more
informed choices and promote substitution toward less hazardous cosmetic ingredients.
Next, a time-limit on the approval of the cosmetic preservatives, as well as colorants
and UV-filters should be introduced. This would ensure that the approval decisions,
and the data they are based on, are updated at a regular interval, and would help to
avoid the continued approval of substances hazardous to human health or the
environment.
 HUMAN AND ECOLOGICAL RISK ASSESSMENT: AN INTERNATIONAL JOURNAL 13

Finally, the focus of this study has been the cosmetic preservatives. Cosmetic preser­
vatives are one of the three groups of cosmetic ingredients that are subjected to an
evaluation by the SCCS. Together with UV-filters and colorants, preservatives are
assessed for their human health hazards to be approved. The remaining cosmetic ingre­
dients are only evaluated for safety to human health in a finished product: an evaluation
that is performed by the producer of the cosmetic products and that remains undis­
closed. For example, perfluorinated substances (PFAS) are often found in cosmetic
products (P€ utz et al. 2022). These substances are not primarily used as preservatives,
colorants or UV-filters; therefore, under the Cosmetic Products Regulation, no safety
assessment is necessary. Which PFAS are used and at what concentrations is not
reported. In fact, despite the obligation for market surveillance by the Member States,
there is currently no database of substances used in cosmetic products. The Cosmetic
Products Regulation already requires full list of ingredients on cosmetic products but
does not require this information to be submitted to any database. The lack of know­
ledge about which substances are present in cosmetic products may lead to ineffective
surveillance but may also have implications for environmental monitoring where a tar­
geted approach is often used. Therefore, we suggest establishing a common database
with information on the cosmetic products and the contained ingredients available on
the EU-market.
The topic of the study can be considered an illustrative example of a wider problem
in chemicals legislation in the EU and, most likely, across the world. Similar issues have
been noted in the European Commission’s Fitness Check of chemicals legislation
regarding other types of chemicals and involving other pieces of legislation. By identify­
ing the root causes, consequences, and potential solutions to regulatory inconsistencies
within the EU, this research may serve as a template for countries and regions facing
analogous challenges.

Conclusions and recommendations

This study has shown that environmentally hazardous substances are among the cos­
metic preservatives approved under the Cosmetic Product Regulation. There are several
indications that environmental aspects of cosmetic ingredients are not effectively man­
aged under REACH and that there are areas which call for improvement in the inter­
face between the CLP, REACH and the Cosmetics Products Regulation.
We suggest a) extending the prohibitions of CMR substances under the Cosmetic
Products Regulation to include the new environmental hazard classes under the CLP
Regulation: PBT/vPvB, PMT/vPvM and endocrine disruptors in the environment b)
removing cosmetic products from the list of exempted regulations for the classification
of mixtures under the CLP Regulation c) introducing a time limit for approval of UV-
filters, colorants and preservatives under the Cosmetic Products Regulation, and d) cre­
ating a common database for all substances used in cosmetic products.
In our opinion, these measures would be in line with the Chemicals Strategy for
Sustainability and would strengthen the protection of the environment from hazardous
cosmetic ingredients.
14 D. KÄTTSTRÖM ET AL.

Author contributions
DK, MÅ and CR designed the study. DK collected and analyzed the data, and wrote the manu­
script. All authors contributed to the discussions and to the manuscript. All authors have red
and approved the final version of the manuscript.

Disclaimer
The findings and conclusions in this article are those of the authors and do not necessarily repre­
sent the views of the organizations.

Disclosure statement
No potential conflict of interest was reported by the authors.

Funding
The authors would like to thank the Horizon Europe Partnership for the Assessment of Risks
from Chemicals (PARC, project number 101057014) and faculty grant from Stockholm
University for funding this study.

Data availability statement

The data that supports the findings of this study are available in the supplementary material of
this article.

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