BADGE

The Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA) program was developed to study the full range of potential health effects from exposure to BPA. The program was initiated by NIEHS, NTP, and the U.S. Food and Drug Administration (FDA) to provide data that can be used for regulatory decisions to provide comprehensive Clarity on the real risk and health effects, particularly concerning reprotoxicity and endocrine disrupting properties of exposure to BPA.

CLARITY-BPA has two components:

• Core Study : A two-year guideline-compliant study of potential BPA toxicity in rats, which was conducted according to federal regulatory and statutory guidelines for toxicity testing.
• Grantee Studies : Studies conducted by university researchers but testing a range of additional endpoints. The Grantee Studies used animals raised in the same conditions and exposed to the same doses of BPA as the Core Study.

These two components combined produced a robust study design that united standard research practices used by regulators with innovative studies conducted at universities.

One key strength was  identical BPA exposure conditions for both components of the study, which were generated by the same facility in the FDA’s National Center for Toxicological Research (NCTR). A second strength was that grantees received blinded Core Study samples, meaning they did not know whether samples had been dosed with BPA or how much, to minimise the potential for bias.

The results of the core study were published in September 2018. In a statement released in conjunction with the report, Dr. Stephen Ostroff, Deputy Commissioner for Foods and Veterinary Medicine at the U.S. Food and Drug Administration (FDA) noted:  “Our initial review supports our determination that currently authorised uses of BPA continue to be safe for consumers.”

A report integrating findings from the Core Study and Grantee Studies is expected from NTP in fall 2019.

For more detailed information please visit:

• https://ntp.niehs.nih.gov/go/clarity_bpa
• https://www.factsaboutbpa.org/scientific…/fda-clarity-study

REACH applies to all chemical substances: those used in industrial processes but also in our day-to-day lives. Therefore, the regulation has an impact on most companies across the EU.

To comply with REACH, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They must demonstrate how a substance can be safely used, and they must communicate the risk management measures to the users.

If the risks cannot be adequately managed, authorities can restrict the use of a substance in different ways. In the long run, the most hazardous substances, the so-called substances of very high concern, should be replaced with less hazardous alternatives.

Epoxy precursors

• Epoxy precursors and non-polymeric epoxy building blocks are REACH registered.
• All registration dossiers are regularly updated.
• Several epoxy building blocks are subject to the so-called Community Rolling Action Plan (CoRAP), a deeper probing substance evaluation organized by ECHA to scrutinize potential hazard concerns which may not have been fully addressed in the registration dossier. Depending on the results of the substance evaluation, a substance may be cleared of all concerns, or alternatively may be subject to further regulatory measures like harmonized classification and labeling (CLH), SVHC identification, and ultimately restriction and/or authorization.
• Industry has a vital interest to provide up-to-date hazard and safe-use information.

BADGE

• BADGE is registered under REACH: 100-1,000 kt/a.
• 2015 aggregated volume EU 291kt.
• 83% industrial, 16% professional (flooring), rest consumer (disappearing).
• Classification: Skin Irrit. 2 // Eye Irrit. 2 // Skin Sens. 1 // Aquatic Chronic 2.

CoRAP 2015 ongoing:

• Human health/suspected CMR: Transgenic rodent assay completed. The results indicate no mutagenic activity in somatic cells of duodenum, stomach or liver.
• Exposure/wide dispersive use, consumer use, aggregated tonnage.

Authorisation:

BPA- have been proposed for prioritisation by ECHA in 2018, which in the future could potentially lead to inclusion into Annex XIV, i.e. authorisation. Please note that BPA is used as a monomer in the manufacturing of epoxy resins, which is an intermediate use.

• Envisioned Scope: small percentage of hardeners containing elevated amounts of BPA as a curing accelerator and co-curing agent.

Restrictions:

UBA, restriction dossier proposal expected during the 2nd half of 2019.

• Envisioned Scope: unclear for the time being.
• Aim: reduce environmental concentration of BPA, predominantly in surface waters.
• Studies show contribution of epoxy and polycarbonate to BPA concentration in the environment is only ca. 1%.

Authorisation or restrictions for BPA will have no impact on epoxy polymers or BADGE, as BPA is used only as an intermediate to create BADGE. Once reacted with epichlorohydrin, the BPA has transformed into a new substance – BADGE. Intermediate uses are exempt from authorisation hence Epoxy resins are not affected by the inclusion into Annex XIV.

Following on a recent decision by the European Chemicals Agency (ECHA), and in accordance with the REACH regulation (EC) No. 1907/2006, it is necessary to modify the “chemical identifiers”, (Chemical Name, CAS Number, EC Number), for a range of low molecular weight Bisphenol A based epoxy resins.

Accordingly, several epoxy resin products can no longer be described as “Reaction products of Bisphenol-A and Epichlorohydrin” and the new “chemical identifiers” shown below will be assigned:

The ERC members have initiated a transition project and will gradually update their Safety Data Sheets (SDS) and labels of all the affected epoxy resin products over the next 12-18 months.

Please note that while there is no impact on the product properties or classification, on receipt of an updated SDS you may need to update your own SDS and/or update existing product notifications and certifications.

The request to assign the CAS No. 1675-54-3 for Bisphenol-A-diglycidylether (BADGE) to the existing Water Hazard Class (WGK) under the assignment no.2007 and the CAS no. 25068-38-6 was submitted to UBA. UBA is currently processing this request on update of the Rigoletto database.