News Release from the IULTCS

02September 2022

IULTCS Asks EU Legislators to Reconsider Proposed Restrictions

Members of IULTCS have collaborated with industry scientists from FILK, Stahl and TFL to prepare a document that was submitted to DG Grow (the European Commission Directorate-General department responsible for EU policy on the single market, industry, entrepreneurship and small businesses) and DG ENV (The Directorate-General for Environment department responsible for EU policy on the environment).

The purpose of preparing the document was to address proposed EU restrictions on the presence of Chrome VI and Bisphenols in leather. It is considered that the new proposed REACH restrictions could seriously impact the leather industry, particularly in the European Union.

The IULTCS document asks the EU for a proper assessment of the impact of these measures on the environment, people and leather manufacture. IULTCS President Jean-Pierre Gualino andExecutive Secretary Dr Luis Zugno stated “Our call is for a more detailed study of data and testing methodology relating to Chrome VI and more time to implement the proposed Bisphenol restrictions".

NOTE: Copy of document sent to DG GROW / DG ENV attached to this news release.

The International Union of Leather Technologists and Chemists Societies, a world-wide organization of professional societies, was established in London in 1897. There are currently 19 Member Societies, 6 Associate Members and 1 Supporting Member - representing some 3000 individual members. This document represents the IULTCS opinion regarding the new proposed REACH restrictions that could seriously impact the leather industry, particularly in the EU. We call for more data regarding Chrome VI and more time to implement the bisphenol restriction. Chrome VI

Chrome VI Proposal from ECHA: Reduce Chrome VI limit in leather from 3 ppm to 1 ppm In our opinion there is no scientific base to change the existing limit to a lower value based on the existing ISO test method. The current ISO method is the best result of many studies and investigations, and is deemed to be the most accurate process to establish a reliable detection limit. Although detection can be reproduced, even at 1 ppm, the necessary upstream process, the extraction of the reagent out of the leather matrix, cannot be reproduced to a higher accuracy than 3 ppm. Too many false positives and negatives would be the result of lowering the detection limit. As long as this is the case, and no other extraction process is in place, there is no scientific justification to lower the detection limit of the existing ISO method

The industry would welcome the opportunity to develop and introduce a new method because the existing test method for measuring Chrome VI in leather (ppm total Chrome VI) does not address the skin exposure to the leather that can cause sensitization; it relates to mg of Chrome VI to one kg of leather. Most leather does not come in direct contact with the skin. Leather articles are typically lined with fabric or non-woven or finished, therefore skin exposure directly to the leather surface is rare and represents the worst-case scenario for Chrome VI sensitization.

Our proposal is the evaluation of the Chrome VI surface transfer using standardized rubbing studies and commercial leather samples with 3 ppm Chrome VI or more. The rubbing studies (e.g. Veslic, Crock and Martindale) should be done with perspiration solutions under dry and wet conditions with, and without, aging. This study can determine the proper Chrome VI concentration expressed as µg/cm2 , and would address the potential risk of skin sensitization, that can induce localized allergic contact dermatitis (ACD). Research exposure assessment studies indicate that a limit of 3 ppm Chrome VI in leather is safe.

Proposals from ECHA:

1. Shall not be placed on the market in mixtures and articles in a concentration equal to or greater than 10 ppm (0.001% by weight). If the concentration in mixtures and articles exceeds 10 ppm, a migration test to determine the migration values need to be conducted

2. Shall not be placed on the market in articles showing a migration value greater than 0.04 mg/l (migration limit) in total during its service life. This migration limit refers to sum of BPA and all BosC present in the respective mixtures and articles

3. Paragraphs 1 and 2 shall apply 24 months from entry into force of the restriction

Table 1: ECHA Propos

Bisphenol F and S are impurities present in syntans used in leather manufacturing. Bisphenol S can also be present as unreacted reagent on sulfone based syntans. The syntans are water soluble tanning polymers (synthetic retanning products) used to complete the tanning of several types of chrome-free leathers or as retanning agent to improve the softness, fullness, filling, temper, buffing of the leathers.

1) Today commercial leathers cannot be made successfully without syntans.

2) In leather application it is not technically feasible to meet the 10 ppm BosC proposed concentration limit, nor the 0.04mg/l migration limit.

3) The existing syntan building blocks will not be able to achieve the requirements outlined in Table 1, i.e., the improvements in the syntans manufacturing processes will not enable us to meet these requirements. We will need new chemistries which are not currently available.

4) IULTCS is developing an ISO method for the determination of bisphenols in leather.

4) IULTCS is developing an ISO method for the determination of bisphenols in leather. The test method probably will be ready mid-2023. The bisphenols determination method in chemicals is also being developed.

We ask for the EU regulatory authorities to evaluate our review in light of the science, to make the proper assessment for the impact of these measures on the environment, people and leather manufacture.

August 30, 2022