Other Events

ARN Information Session on CLH Dossier for Rosin Resins and Rosin Derivatives

The public consultation will launch in the coming weeks

Tuesday, May 27, 2025

7:00 AM - 9:00 AM (EDT)

Event Details

In August 2023, ECHA published an Assessment of Regulatory Needs (ARN) document for Rosin and its derivatives, in which reprotox concerns were expressed. This ARN has subsequently led to a Harmonized Classification and Labelling (CLH) assessment on the substances by the Norwegian Environmental Protection Agency (the national Member State Competent Authority [MSCA] on REACH in Norway). Following up on the ARN report, the Norwegian Competent Authorities (NCA) have assessed these ARN substances upon request by ECHA.

PCA, along with H4R and HARRPA, requested the NCA to give advance notice in the case CLH proposal assessments were going to be submitted to ECHA. In July 2024, the NCA informed us that they submitted CLH intention assessments proposals for the following 6 substances for classification based on concerns for reproductive toxicity:

CAS	EC	Substance
8050-09-7	232-475-7	Rosin
65997-05-9	500-163-2	Rosin, oligomers
65997-04-8	266-040-8	Rosin, fumarated
8050-28-0	232-480-4	Rosin, maleated
97489-11-7	307-051-0	Resin acids and Rosin acids, fumarated, esters with glycerol
94581-17-6	305-516-2	Resin acids and Rosin acids, maleated, esters with pentaerythritol

Although the NCA stated that they submitted their CLH intentions to ECHA, this has not yet been published on the Registry of CLH intentions page on the ECHA website. Further information, e.g., on the category of the proposed classification, potential additional classifications, etc., will follow with the publication of the Registry of Intentions (ROI).

We are in contact with the NCA and have reached out for additional details, which they may or may not be able to provide, i.e. before the ROI is published. However, we learned that they submitted their CLH dossiers to ECHA last week, after which the next stages of the CLH process follow. Since these dossiers need to go through an accordance check by ECHA first, the public consultation of the dossiers is expected to start late-Q2 or early-Q3/2025.

We will closely monitor this and invite you to our joint PCA/H4R/HARRPA webinar on 27 May 2025 from 13h00 to 15h00 CEST/07h00- 09h00 EST, on the rosin and rosin derivatives CLH proposal for an update. The public consultation will launch in the coming weeks, so we believe this is the right time to update everyone and discuss possible contributions. Please follow this link to register for the upcoming webinar, and the details will be emailed to you directly.

We issued the attached statement in November 2024 that contains the formal joint position of PCA, H4R, and HARRPA, provides the background necessary to understand the reasons for PCA’s position on this issue, and is also intended to share some insights on the next possible steps. This is also available on our website and can be used in your stakeholder communications on this matter.

Please note that the PCA disagrees strongly with these proposed classifications since, based on the available toxicological data, none of these substances raises any concern for reprotox hazard and therefore do not meet the criteria for classification. Our position is unchanged: a reproductive toxicity classification for any of the above substances is scientifically not justified. And therefore, PCA, along with HARPPA and H4R, will contest such a classification proposal. We will publish updated position statements and information on our website once the CLH Intentions have been published on the ECHA website.

Please treat this message as confidential and only forward it to stakeholders affected by the classification and/or who would benefit from the content and participation.