Bisphenols & skin sensitisers in leather production

Guest Writer: Dietrich Tegtmeyer, LANXESS GmbH

New regulations for Bisphenols & Skin Sensitizing Chemicals under discussion at ECHA

Changes in regulations and restrictions are an ongoing topic for several decades. The European Chemicals Agency (ECHA), as the organization in charge for Europe, has a strict, interactive, and scientific based process in place, which must be followed before new restrictions potentially get in place in restricted substances lists, such as REACh Annex XVII.

These cases are both relevant for the leather industry and have been started for the two cases of Bisphenols and Skin Sensitizer Chemicals. Although it may be 2024 – 2026 until potential restrictions are enforced, it is important to start the discussion already today, and participate with scientific based results and studies in the interactive process. TEGEWA, the German-based association representing leather and textile chemicals producers, has formed an expert group on these topics to coordinate the necessary steps and communication on behalf of the leather chemicals industry.

The following information was presented in Spring 2021 member meeting and summarizes the current status. If there are further questions on these topics, the LWG will be happy to coordinate a proper and accurate response.

Bisphenols

What are they?

Bisphenols (BP) are a family of chemical raw materials used for various plastics, coatings and polymers. Traces of the raw materials have been found in certain household products.

The focus currently lies on 3 chemically different types of BPs:

  • Bisphenol A (BPA) – used in plastic bottles, food packaging, piping, etc.
  • Bisphenol S (BPS) – used as raw material in retanning chemicals
  • Bisphenol F (BPF) – generated as an impurity in some retanning chemicals

BPA is the main compound of concern. It makes up approximately 98 % of the combined production volume of BP’s. BPA has been found to be a low potency endocrine disruptor and is restricted, for example by REACH.

BPF and BPS can be found in traces in leather from the raw materials for synthetic tanning agents. The impact on humans and environment is under further investigation.

New restrictions proposal

In 2020, two EU member states proposed further regulatory actions: Classification and Restriction. The announced restriction proposal refers to Bispenol A (BPA) and “similar substances”. Chemicals with BPs content above a threshold may be restricted to industrial use (workplace safety & waste treatment). A REACH restriction will establish a threshold for consumer articles as well (leather), not only chemicals.

A final proposal is expected to be submitted to ECHA in late 2021 and will go into the public consultation phase. Any legislation resulting from the proposal is only expected a few years later, in 2025-26.

Skin sensitizing chemicals

What are they?

Skin sensitizing chemicals are substances that cause an allergic response following skin contact. Individual skin sensitizers are already restricted under REACH, for example Chromium VI, Nickel, and DMFu. A new proposal is being considered by REACH-ECHA that would extend restrictions and establish limits for leather & textiles that contain skin sensitizing chemicals in general.

What does this mean for leather?

The current 3mg/kg limit for Cr VI has been challenged, but the newly proposed 1mg/kg would need a valid test method. The proposed limit for Cobalt & Nickel is 20mg/kg, but the current test method does not distinguish between free and complexed metal dyes. Additionally, the default limit is proposed at 110 ppm for all skin sensitizers (SDS: “H317”).

A final proposal for skin sensitizers is expected to be submitted to ECHA shortly, in Q2 2021, and will go into the public consultation phase. Any legislation resulting from the proposal is only expected a few years later, in 2024-25.