Regulations on bisphenols

Regulations on bisphenols in leather

Since the restriction proposal on bisphenols and the addition of Bisphenol-S to the California Proposition 65-list, we have received numerous requests from the leather industry about bisphenols and the relation to leather chemicals.

In this article we give you an overview of the current and pending restrictions and an expected timeline of the process.

Update, Augustus 2023: European legislation is changing
By the end of 2024 the maximum amount of bisphenol in chemicals and in leather has to be below 500 ppm. By 2030 it must be even lower: <10ppm.

Update, October 2023: Re-evaluation
After thorough review of the feedback received, the German authorities have determined that a substantial re-evaluation of the rationale behind the proposed restriction is essential to effectively meet the intended goals. This revision necessitates a new definition outlining the boundaries of the proposed restriction.

Therefore, the German authorities have officially withdrawn the bisphenol restriction dossier until further notice, for the necessary adjustments and scope realignment. Once finished, the revised dossier will then be resubmitted to ECHA for further consideration by the scientific committees, followed by a public commentary phase. No timeline has been given. The resubmission of the restriction proposal will be announced via ECHA’s Registry of Intentions.

The article and whitepaper will soon be updated with this new information.

EU Regulations – Current

What are the current restrictions/classifications regarding Bisphenols?

Until now BPA has received most attention because it is the most widely used type and it is used in food contact applications. BPA is restricted in the EU under REACH-restrictions 30 and 66. It is identified as toxic for reproduction, irritating for the respiratory tract, skin sensitizer and causing eye damage. Germany conducted a REACH substance evaluation on BPA and determined that further regulatory measures are necessary with respect to environmental releases of BPA. In the subsequent Regulatory Management Option Analysis (RMOA), Germany concluded that BPA ought to be identified as a Substance of Very High Concern (SVHC) due to its endocrine disrupting properties for the environment. In a subsequent step, a targeted restriction should follow to minimize the environmental releases of BPA. BPA was subsequently identified as an SVHC due to its endocrine disrupting properties for humans and the environment and was added to the candidate list in 2017 and 2018, respectively.

Currently, there is no harmonized classification for BPS. In the EU REACh registration, it is classified as suspected reprotoxic.

For BPF no classification data is available, due to the absence of a REACh registration.

EU Regulations – Pending

What are the pending restrictions/classifications regarding bisphenols?

Restriction proposal for BPA, BPF, BPS and other Bisphenols

Following the identification of BPA as SVHC, Germany submitted a restriction proposal to adequately address the potential risks to the environment from relevant uses and functions BPA and/or other bisphenols with similar hazard profiles which might be used as drop-in alternatives. Since bisphenols are very similar compounds from a molecular point of view, other bisphenols including BPS and BPF are suspected of having the same toxicological effects and are therefore included in the restriction proposal. Currently, the entry made to the registry of intentions for the restriction is as follows:

1. Restricting the use as an additive and the content in articles (0.02% by weight)
2. Restricting content of residues (unreacted monomer) in articles – also for imported goods (0.02% by weight)
3. Restricting the use of mixtures with content of 0.02% by weight for industrial and professional uses where strictly controlled conditions cannot be assured, e.g. in nonautomated processes and for consumer uses.
4. Introducing release rates for BPA from articles (products and subassemblies) during service life (weathering, leaching due to cleaning action) preventing release into the environment and/or (direct) migration to organisms

Source: Echa

Harmonized classification

There is an intention for a harmonized classification and labelling of BPS as reprotoxic 1B. This would mean that all products containing >0,3% BPS will be classified and labelled. This classification would also qualify BPS as SVHC. Manufacturers or importers of articles containing > 0,1% of an SVHC should submit a SCIP notification[1].

The harmonized classification does not involve restrictions, or prohibition as long as the manufacturer applies the correct CLP[2] classification to his product.

[1] For more information we refer to https://echa.europa.eu/nl/scip

[2] EU Regulation on classification, labelling and packaging of substances and mixtures

What happens in the meanwhile, while the new regulations are pending?

While new regulations are pending, the current regulations apply. During the commenting phases stakeholders can submit their comments. Outcome of this process will depend on the scientific evidence supplied with the comments.

Once the regulations approach their final form, companies will start adjusting their production processes where necessary. Once the restriction is published, a transition period will be included in the legal text.

Is it allowed for leather to exceeds the set limit?

The harmonized classification does not involve restrictions, or prohibition as long as the manufacturer applies the correct CLP classification to his product.

Once the proposed restriction[1] comes into force, (leather) articles containing > 0.02% of any bisphenol are prohibited in the EU. This limit will be for individual bisphenols, there will be no summation limit for all bisphenols combined.

[1] For more information we refer to Echa

EU – Timeline

When can we expect the proposed changes to come into force?

For the EU restriction process the timeline is as follows:

RAC: Committee for Risk Assessment
SEAC: Committee for Socio-economic Analysis
WTO: World Trade Organization

California Proposition 65

What is California Proposition 65?

Proposition 65 requires businesses to provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects or other reproductive harm. These chemicals can be in the products that Californians purchase, for in their homes or workplaces, or that are released into the environment. By requiring that this information be provided, Proposition 65 enables Californians to make informed decisions about their exposures to these chemicals.

Proposition 65 also prohibits California businesses from knowingly discharging significant amounts of listed chemicals into sources of drinking water.

Proposition 65 only warns about the exposure to a listed chemical. It does not ban or restrict the use of any given chemical. The concentration of a chemical in a product is only one part of the process to determine whether consumers must be warned about an exposure to a listed chemical.

Which compounds are on the California Proposition 65 list?

The California Proposition 65 list is quite long. For a full overview we refer to https://oehha.ca.gov/proposition-65/proposition-65-list.

BPS was added as a high priority substance in December 2020 for possible consideration for listing. BPS is not yet included in the Proposition 65 list.

BPA is listed in the Proposition 65 list. Its Maximum Allowable Dose Level (MADL) is set to 3 µg/day (dermal exposure from solid materials). This is not easily translated into a maximum concentration in leather.

Determination of bisphenols in chemistry and leather

How can bisphenols be determined in retanning agents?

Currently there is no commonly agreed standardized ISO method for the bisphenol determination in both chemicals (leather process auxiliaries) and leathers. Renown institutes/organizations in our industry are looking into a standardized ISO method. SMIT is in direct contact with some of these institutes/organizations and follows the status of the ISO definition.

The method that will be used will most likely be a HPLC with a phenyl-based column system for isolation and a Mass Spectroscopy (MS) and/or UV detector for detection, since with this method all the bisphenols of interest (BPA, BPS, BPF) can relatively simple be isolated from most of the other (matrix) components and since all the bisphenols of interest contain conjugated ring structures, they can be detected by MS and UV detector.

When the official ISO method has been established, this document will be updated accordingly.

How can bisphenols be determined in leather?

Currently there is no commonly agreed standardized ISO method for the bisphenol determination in both chemicals (leather process auxiliaries) and leathers. Renown institutes/organizations in our industry are looking into a standardized ISO method. SMIT is in direct contact with some of these institutes/organizations and follows the status of the ISO definition. Based on the information received 2 methods are evaluated: HPLC and heated ultra-sonification.

The HPLC method that is used for the determination in the chemicals can also be used for the determination of bisphenols in leathers, although interferences from other leather processing chemicals and hide matrix components, can be expected.

For extraction of bisphenols from the leather, all contacted institutes use a heated ultra-sonification procedure in a suitable extraction solvent. Unfortunately, there is not yet an ISO method for the extraction procedure, leading to interlaboratory variations in results up to 100%.

When the official ISO method has been established, this document will be updated accordingly.