Commission proposes exemptions to UV-328 ban under POPs Regulation

Chemicals | By Scott Stephens, MPA

Aug. 06, 2024

The European Commission plans to implement exemptions introduced under the Stockholm Convention’s 2023 ban of UV-328, an ultraviolet-light absorbing persistent organic pollutant (POP). Specifically, the EU executive’s proposal seeks to harmonize the POPs Regulation, carving out exclusions for mechanical separators in blood collection tubes, triacetyl cellulose film in polarizers, and photographic paper, among other exempted articles containing UV-328.

The Stockholm Convention and its implementation in the EU

  • Adopted in 2001, the Stockholm Convention is an international treaty aimed at limiting the production, release, and damaging effects of persistent organic pollutants (POPs). These organic compounds are resistant to environmental degradation and can present hazards to humans and wildlife far from their point of origin. This is largely due to their capacity to travel great distances and across international borders, transported by wind, water and transitory species.
  • The convention currently lists 34 entries, categorized among three levels of varyingly strict annexes. Annex A requires the production and use of 30 entries to be eliminated, with some specific exemptions. Annex B restricts the production and use of the two listed entries – DDT and PFOS, its salts and PFOSF – allowing certain exemptions that should otherwise be eliminated. Annex C requires stakeholders to reduce “unintentional releases” of the seven listed entries with the objective of “continuing minimization and, where feasible, ultimate elimination.” Some Annex C entries are repeated from Annex A.
  • Most recently, in May 2023, the conference of the parties adopted amendments adding the substances dechlorane plus, methoxychlor, and UV-328 to Annex A of the convention. The substances were introduced in accordance with their respective decisions, including Decision SC-11/11 (note: document downloads to local drive) for UV-328, which includes several specific exemptions.
  • Regulation (EU) 2019/1021 (POPs Regulation) serves to codify the Stockholm Convention’s commitments into EU law. Pursuant to Article 1, the regulation “prohibit[s], phas[es] out as soon as possible, or restrict[s] the manufacturing, placing on the market and use of” the POPs “subject to the Stockholm Convention on Persistent Organic Pollutants,” and to the Aarhus Protocol.

EU executive is seeking feedback on proposed amendment to POPs Regulation banning UV-328

  • On July 30, 2024, the Commission published a draft delegated regulation on its “Have your say” portal, allowing four weeks for stakeholders and interested parties to contribute feedback on the proposal to align EU law with the convention by including UV-328 in Part A of Annex I of the POPs Regulation; this part reflects the substances listed in the convention. Article 15(1) of the POPs Regulation empowers the Commission to amend annexes “to adapt them to changes to the list of substances set out in the Annexes to the Convention or the Protocol.”

Identity, use profile, regulation in the EU

  • UV-328 (CAS RN 25973-55-1) belongs to a class of substances called phenolic benzotriazoles (BZTs). The substance absorbs the full spectrum of ultraviolet (UV) light. UV-328 is used in a wide range of applications as a UV absorber and stabilizer.
  • UV-328 is regulated as a substance of very high concern (SVHC) on Annex XIV, the authorization list, of Regulation (EC) 1907/2006 on the registration, evaluation, authorization and restriction of chemicals (REACH). However, according to Recital 5 of the draft regulation, no application was ever submitted to obtain authorization for the continued use of UV-328 beyond its November 2023 sunset date, indicating that the substance is no longer manufactured in the EU.
  • Nevertheless, it appears the substance appears is still imported into the EU in great quantities, given that active registration dossiers exist at annual tonnage levels between 100 and 1,000 metric tons. According to the registrations, the substance is used in many different consumer, professional use and industrial applications, including polymers, coatings, air care products, adhesives and sealants, lubricants and greases, polishes and waxes, and washing and cleaning products.

Proposed exemptions

  • The EU executive is proposing to implement several exemptions as stipulated in the convention to account for certain products containing UV-328 imported into the EU “until the substance is fully substituted.”
  • Five-year exemptions for placing on the market and use are carved out for articles containing the substance in (1) land-based motor vehicles, including cars, motorcycles, agricultural and construction vehicles, and industrial trucks; (2) mechanical separators in blood collection tubes; (3) triacetyl cellulose film in polarizers; and (4) photographic paper.
  • Also exempted are spare parts for (1) land-based motor vehicles; (2) stationary industrial machines for use in agriculture, forestry and construction; and (3) liquid crystal displays in instruments for analysis, measurements, control, monitoring, testing, production and inspection, other than for medical applications. These spare parts may continue to be used until the end of their service life or until 2044, whichever comes first.
  • A separate exemption applies to spare parts used in liquid crystal displays for medical and in vitro diagnostic medical devices. They may be used until the end of their service life.
  • All exempted articles may continue to be used that were already in use before or on the day their respective exemptions expired.
  • Finally, the proposed regulation establishes an exemption for unintentional trace contaminants of UV-328 present in substances, mixtures or articles, where concentrations of the substance are equal to or below 1 mg/kg (0.0001% by weight). This exemption is in accordance with Article 4(1)b of the POPs Regulation.

Analysis and next steps

  • Companies importing products that contain UV absorbers or stabilizers into the EU will want to determine whether their products contain UV-328. If so, they will need to make sure they are covered by the proposed exemptions. Based on the quantities and wide scope of applications documented in the active registrations for UV-328, it seems plausible that some products containing the substance could fall outside these exemptions, meaning their import will be prohibited when this delegated regulation begins to apply.
  • The regulation will begin to apply starting on February 26, 2025, according to the Commission’s proposal. Accordingly, the five-year exemptions expire on February 26, 2030.
  • The Commission has opened a four-week consultation to gather feedback on the proposed regulation, with comments being accepted until August 27.
  • Adoption of the delegated regulation was originally expected in the third quarter of 2023, according to the “Have your say” initiative. Considering the proposed application date, its adoption will likely happen toward the end of this year, or early next, with publication in the Official Journal of the EU soon after.

Featuring previous analysis by Rayan Bhargava.

To contact the author of this piece, email Scott Stephens ( sstephens@agencyiq.com).
To contact the editor of this piece, email Kari Oakes ( koakes@agencyiq.com).

Key Documents and Dates

 

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