Other Events

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

Tuesday, May 27, 2025

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

Event Details

This session aims to provide stakeholders with:

An update on the current status of the CLH proposals.
Insights into the potential implications for the industry.
Guidance on how to engage in the upcoming public consultation process.

Potential classifications under the current ECHA ARN, with a specific focus on the use of rosin in different applications, will have considerable direct and indirect effects on vital products used in critical applications, the global economy, and various industry sectors.

The PCA, H4R, and HARRPA disagree 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. Should the classification proposal include these substances, we are jointly examining all scientific data to support our position that a reproductive toxicity classification for any of the below substances is scientifically not justified and therefore, PCA, along with HARPPA and H4R, will contest such a classification proposal. We are also assessing the implications of product classification and regulatory compliance, as well as the effect this will have on multiple industries and their stakeholders.

As we continue to monitor this closely, we 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 opportunities to support the advocacy and media relations efforts during the limited 60-day public consultation phase.

Please follow this link to register for the upcoming webinar, and the details will be emailed to you directly. We recommend you include any colleague involved with the procurement or sale of raw materials, regulatory staff, and the scientific team/toxicologists.

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

Background:

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 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.

Affected industries:

Adhesives and Sealants

Coating Products

Concrete, Cement and Plaster

Cosmetics and Personal Care Products

Inks and Toners

Paper Chemicals

Pigments, Pigment Preparations and Masterbatch

Polishes and Waxes

Polymer Modification / Processing

Polymer/Rubber Production

Road and Construction applications