Out of REACH: environmental hazards of cosmetic preservatives

Figures & data

Table 1. Data sources and type of data collected from the European Chemicals Agency’s database.

Data source	Type of data collected
Annex V to the Cosmetic Products Regulation (EC) 1223/2009 – approved cosmetic preservatives	Name, EC and CAS number of all approved cosmetic preservatives
C&L Inventory	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.
REACH Substance Brief Profile	Registration status and annual tonnage reported in the registration dossier under REACH
REACH registered substance factsheet	Outcome of the PBT assessment, outcome of the biodegradation screening tests in water
Community rolling action plan (CoRAP) list	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
Registry of restriction intentions until outcome	Reason for inclusion and the outcome of the process of substances that have been proposed for restriction under REACH
Annex XVII to REACH - list of substances subject to authorization	Reason for inclusion and the outcome of the process of substances restricted under REACH
Registry of SVHC intentions until outcome	Reason for inclusion and the outcome of the process of substances that have been proposed for identification as SVHC under REACH
Candidate List of substances of very high concern for authorization	Reason for inclusion and the outcome of the process of substances identified as SVHC under REACH
Annex XIV to REACH - restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles	Reason for inclusion and the outcome of the process of substances that require aunder REACH

Figure 1. The number of cosmetic preservatives that are not considered to be of concern (n = 67) and those that fulfill at least one criterion as defined in this study to be considered of environmental concern (n = 70) of the total number of cosmetic preservatives (n = 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.

Table 2. Approved cosmetic preservatives subjected to Substance Evaluation under REACH, the initial grounds for concern, and the outcome of the process.

Substance identity	Annual tonnage (tonnes per year) reported under REACH	Environmental hazard classification under the CLP(S) self-classification, (H) harmonized classification	Biodegradation in water - screening tests reported Under REACH	Assessment of the P criterion reported in the PBT assessment under REACH	Year of evaluation and Initial grounds for concern	Status and outcome
Sodium metabisulfite EC# 231-673-0 CAS# 7681-57-4	≥100 000 to <1 000 000	(S) Aquatic Chronic 3	Not applicable (inorganic)	Not applicable (inorganic)	2014 Suspected CMR Exposure of environment Exposure of sensitive populations High (aggregated) tonnage Wide dispersive use	Concluded: Suggested harmonized classification and labeling under the CLP
Methylparaben EC# 202-785-7 CAS# 99-76-3	≥100 to <1000	(S) Aquatic Chronic 2	Readily biodegradable	Not P/vP	2014 CMR Potential endocrine disruptor Consumer use Exposure of sensitive populations High (aggregated) tonnage Wide dispersive use	Information requested
1-(4-Chlorophenyl)-3-(3,4-dichlorophenyl) urea EC# 202-924-1 CAS# 101-20-2	Not currently manufactured	(S) Aquatic Acute 1 (S) Aquatic Chronic 1	Readily biodegradable	P	2014 Suspected Reprotoxic Potential endocrine disruptor Wide dispersive use	Concluded: Evaluation terminated with the open concern due to lack of active registrants
5-Chloro-2-(2,4-dichlorophenoxy) phenol EC# 222-182-2 CAS# 3380-34-5	Not currently manufactured	(H) Aquatic Acute 1 (H) Aquatic Chronic 1	Inherently biodegradable	Not P/vP	2019 Potential endocrine disruptor Suspected PBT/vPvB High (aggregated) tonnage	Follow-up: Information requested
1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one (climbazole) EC# 253-775-4 CAS# 38083-17-9	≥10 to <100	(S) Aquatic Acute 1 (S) Aquatic Chronic 1	Under test conditions no biodegradation observed	vP	2012 Suspected CMR Consumer use Wide dispersive use	Follow-up: Information requested
Steartrimonium chloride EC# 203-929-1 CAS# 112-03-8	≥100 to <1000	(S) Aquatic Acute 1 (S) Aquatic Chronic 1	Readily biodegradable	Not P/vP	2018 Suspected PBT/vPvB Exposure of environment Wide dispersive use	Withdrawn, concerns resolved

Table 3. Cosmetic preservatives of environmental concern identified as substances of very high concern (SVHCs) under REACH, their environmental classification under the CLP Regulation, as well as justification for inclusion in the Candidate List for Authorization.

Substance identity (name, EC number, and CAS number)	Environmental hazard classification under CLP	Biodegradation in water - screening tests reported Under REACH	Assessment of the P criterion reported in the PBT assessment under REACH	Justification for identification as SVHC and inclusion in the Candidate List for Authorization
Glutaraldehyde; Pentane-1,5-dial EC# 203-856-5 CAS# 111-30-8	(H) Aquatic Acute 1 (H) Aquatic Chronic 2	Readily biodegradable	Not P/vP	Respiratory sensitizing properties (Article 57(f) - human health)
Butyl 4-hydroxybenzoate EC# 202-318-7 CAS# 94-26-8	(S) Aquatic Chronic 3 (S) Aquatic Chronic 4	Readily biodegradable	Not required (low tonnage)	Endocrine disrupting properties (Article 57(f) - human health)

Data availability statement

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