The European Chemicals Agency (ECHA) has published an assessment of regulatory needs (ARN) concluding that no EU-wide regulatory risk management action is currently needed for a group of 20 acrylate and methacrylate amines, given the information available on them today. However, ECHA added a caveat indicating that some group members, which manifest skin sensitizing properties, may be affected in the future by separate ongoing investigative work into skin sensitizers in consumer mixtures.
What is an ARN?
- The assessment of regulatory needs (ARN) is an auxiliary method ECHA uses under its Integrated Regulatory Strategy (IRS) “to help authorities conclude on the most appropriate way to address the identified concerns for a group of substances or a single substance.” Based on data collected through the European Union’s main chemicals control legislation – Regulation (EC) 1907/2006 on registration, evaluation, authorization, and restriction of chemicals (REACH) and Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) – ARNs seek to expedite the process by which hazardous substances that are not adequately controlled are identified and prioritized for regulatory risk management (RRM) measures under the EU chemicals management framework.
- ARNs consider all known information about the substances in question, including substance or substance group identity, documented hazard properties, quantities present on the EU market, uses and applications, and potential exposure and environmental release estimates.
- Based on this data, which is sourced in large part from REACH registration dossiers and CLP notifications, ECHA delivers an initial determination on whether EU-wide RRM measures — like restricting or authorizing substances under the REACH Regulation or assigning harmonized classification and labeling (CLH) to substances under the CLP Regulation — are necessary to initiate.
- The assessments also determine whether the generation of more data is needed to make an initial decision about taking RRM action. In certain instances, ECHA may recommend undertaking investigatory exercises, such as compliance checks (CCH) under REACH dossier evaluation, to produce more data on relevant substances or substance groups.
The significance of the ARN in the EU chemicals framework
- The ARN is not formally defined under EU chemicals legislation, rather it seeks to support REACH and CLP RRM processes in promptly addressing substances of concern. These substances include carcinogens, mutagens, and reproductive toxins (CMRs); persistent, bioaccumulative, and toxic substances (PBTs and vPvB); and other substances of equivalent concern like endocrine disruptors and respiratory sensitizers.
- Conclusions made in the assessments do not automatically trigger formal regulatory processes under REACH or CLP, such as restrictions, authorization or CLH. Rather, authorities in the EU (e.g., member states or the Commission) must first act on them. For example, on the basis of a regulatory needs assessment, a member state may initiate a restriction under REACH by filing an intention via ECHA’s Registry of Intentions until outcome to submit a restriction proposal pursuant to REACH Annex XV requirements.
- With respect to scope, ECHA explains that any substance, or group of substances, may be subject to a regulatory needs assessment, regardless of hazards or uses, “previous regulatory history or lack of such,” or the level of information available on such substance(s).
- Assessing the regulatory needs of substances is an iterative process. ECHA points out that assessments “can start from a low level of information and certainty on the best way forward,” and eventually develop, through data generation or discovery, to a point where “more definitive regulatory management options for the (groups of) substance(s)” may be proposed. In other words, just because an ARN concludes that substances don’t require RRM action today doesn’t mean future findings about them won’t lead to action being taken resulting in their regulation tomorrow.
- A list of all substances for which an assessment has been completed or is under development has been made available on ECHA’s website to increase transparency and predictability of the EU authorities’ activities.
ECHA published the ARN for a group of 20 acrylate and methacrylate amines
- For purposes of the assessment, ECHA grouped together 20 structurally similar substances“based on the presence of amine moiety combined with the acrylate and methacrylate moiety.” ECHA notes that the group consists of 11 acrylate and 9 methacrylate amines, of which 17 have been fully registered, one only pre-registered, and two only notified under the CLP Regulation. [See page 10 of the ARN document for a representation of the group’s common chemical structures and pages 2-5 for a breakdown according to data source (e.g., registration type, CLP notification).]
- The substances are further divided into three subgroups based on structural similarities and potential hazards related to their functional groups. Subgroup 1 contains four entries with known or potential hazard for skin sensitization, as well as for reproductive toxicity; in addition, one member of this group (i.e., EC No. 219-460-0) possesses known or potential hazard for specific target organ toxicity – repeat exposure (STOT-RE) and potential hazard for aquatic toxicity. Subgroup 2 contains nine entries with known or potential hazard for STOT RE (neurotoxicity) and for reproductive toxicity; additionally, one member of this group (i.e., EC No. 417-560-6) exhibits potential hazard for skin sensitization. Subgroup 3 comprises seven entries with known or potential hazard for skin sensitization [See Annex I on pages 16-20 of the ARN document for a list of each entry’s harmonized and/or self-classification].
- The 20 substances, listed according to their respective subgroups, are:
|Substance name||EC/List number||CAS number|
|Subgroup 1: Secondary/tertiary amines acrylate/methacrylate|
|2-(dimethylamino) ethyl acrylate||219-460-0||2439-35-2|
|Subgroup 2: Quaternary amines acrylate/methacrylate|
|dimethyl[2-[(2-methyl-1- oxoallyl)oxy]ethyl](3- sulphopropyl)ammonium hydroxide||222-860-8||3637-26-1|
|[2-(methacryloyloxy)ethyl]trimethylammonium methyl sulphate||229-995-1||6891-44-7|
|[2-(acryloyloxy)ethyl]trimethylammonium methyl sulphate||236-029-2||13106-44-0|
|ethyldimethyl[2- [(2-methyl-1-oxoallyl)oxy]ethyl]ammonium ethyl sulphate||236-195-6||13223-03-5|
|benzyldimethyl[2-[(1- oxoallyl)oxy]ethyl]ammonium chloride||256-283-8||46830-22-2|
|benzyldimethyl[2 -[(2-methyl-1- oxoallyl)oxy]ethyl] ammonium chloride||256-288-5||46917-07-1|
|3,5,8-Trioxa-4- phosphaundec- 10-en-1- aminium, 4- hydroxy- N,N,N,10- tetramethyl-9- oxo-, inner salt, 4-oxide||417-560-0||67881-98-5|
|Subgroup 3: Ethoxylates/propoxylate acrylate amines|
|Propylidynetrimethanol, ethoxylated, esters with acrylic acid, reaction products with diethylamine||500-425-6||159034-91-0|
|Glycerol, propoxylated, esters with acrylic acid, reaction products with diethylamine||500-744-0||162492-10-6|
|2-Propenoic acid, (1-methyl-1,2- ethanediyl) bis[oxy(methyl- 2,1-ethanediyl)] ester, reaction products with diethylamine||601-101-8||111497-86-0|
|1-Butanamine, N-butyl-, reaction products with polyethylene- polypropylene glycol ether with trimethylolpropane (3:1) acrylate||
|ethanamine, N- ethyl-, reaction products with polyethylene- polypropylene glycol ether with trimethylolpropane (3:1) acrylate (>1 <6.5 mol EO and >1 < 6.5 mol PO)||
|1-Butanamine, N-butyl-, reaction products with polyethylene glycol monoacrylate ether with trimethylolpropane (3:1)||
|propylidynetrimethanol, ethoxylated, esters with acrylic acid and its reactions products with dibutylamine||701-363-4||—|
Uses and exposure
- The eleven entries belonging to subgroups 1 and 3 are used in industrial settings, as well as extensively in professional and consumer applications, including in coatings and paints, inks and toners, adhesives and sealants, as well as in polymer preparations and products. REACH registration dossiers documented additional uses for one substance of subgroup 1 – 2-dimethylaminoethyl methacrylate (EC No. 220-688-8) – which is used in fillers, putties, plasters and modeling clay, cosmetics, washing and cleaning products, paper, board and textile treatment products (with article service life) and lubricants and greases. As expected, given their widespread use, exposure to the substances of these two subgroups was found to be significant in industrial, professional and consumer contexts. The assessment concludes that exposure “to the substances as such, in mixtures, and as a residual monomer in (pre-) polymer preparations, and possibly in articles cannot be excluded.”
- Uses of the nine entries of subgroup 2 take place predominantly in industrial settings, as intermediate and laboratory chemicals. The assessment found that they pose limited risk of exposure for workers.
ARN finds RRM measures not necessary at present given information available
- The ARN for acrylate and methacrylate amines concludes that further RRM action is not required for this group, based on the current availability of relevant information. ECHA has reached this conclusion although some members of the group of substances have the potential for reproductive toxicity and neurotoxicity and, concerning subgroups 1 and 3, the potential for skin sensitization.
- The assessment justifies no further action, pointing out that correct self-classification by registrants and adequate product labeling “should trigger adequate risk management measures according to workplace legislation” and “provide consumers with sufficient information to manage risks arising from the use of mixtures containing these substances.”
- The assessment highlights a concern about the potential for skin sensitizers being present in consumer mixtures containing substances of this group (i.e., subgroups 1 and 3) and whether they are adequately controlled under current conditions. ECHA explains that barring the outcome of separate ongoing investigations into this issue, it was concluded that no further action is needed at present. However, ECHA emphasizes, the outcome of this investigative work could affect the regulatory actions on substances in this group sometime in the future.
To contact the author of this analysis, please email Scott Stephens ( [email protected])
To contact the editor of this piece, please email Patricia Iscaro ( [email protected])
Key Documents and Dates
- Assessment of regulatory needs for acrylate and methacrylate amines (published on ECHA website January 10, 2023; version 1.0 dated October 14, 2021)