Regulations of Ethylene Vinyl Alcohol

EVOH

Identifiers

FormulaC2H4·CAS74-85-1·EC200-815-3·HS2901.21

Hazards

FlammableCompressed GasIrritant

How does the regulatory treatment of ethylene vinyl alcohol differ by market or product category?

Regulatory treatment of ethylene vinyl alcohol varies by market and product category, with the most direct evidence covering ethylene as a monomer rather than the copolymer. In the EU, ethylene is an active REACH registered substance and subject to ECHA C&L notifications, while in the US it is active under TSCA with CDR reporting obligations and is listed as a DHS chemical of interest with a 10,000-pound release screening threshold. For food-contact applications, US FDA food additive regulations list ethylene under multiple sections, indicating permitted uses in specific food-contact materials. In Australia and New Zealand, ethylene appears on industrial chemical inventories, with New Zealand approving it with controls.

Which United States federal regulations apply to Ethylene vinyl alcohol?

5 regulations

EPA TSCA Regulatory Flag

Ethene is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of Ethene are required to report information about their production and use of this chemical to the EPA under the Toxic Substances Control Act (TSCA). (40 eCFR Part 711)

FIFRA Requirements

Ethylene is exempted from the requirement of a tolerance for residues when: (a) For all food commodities, it is used as a plant regulator on plants, seeds, or cuttings and on all food commodities after harvest and when applied in accordance with good agricultural practices. (b) Injected into the soil to cause premature germination of witchweed in bean (lima and string), cabbage, cantaloupe, collard, corn, cotton, cucumber, eggplant, okra, onion, pasture grass, pea (field and sweet), peanut, pepper, potato, sweet potato, sorghum, soybean, squash, tomato, turnip, and watermelon fields as part of the U.S. Department of Agriculture witchweed control program.

FDA GRAS Notices

Ethylene is exempted from the requirement of a tolerance for residues when: (a) For all food commodities, it is used as a plant regulator on plants, seeds, or cuttings and on all food commodities after harvest and when applied in accordance with good agricultural practices. (b) Injected into the soil to cause premature germination of witchweed in bean (lima and string), cabbage, cantaloupe, collard, corn, cotton, cucumber, eggplant, okra, onion, pasture grass, pea (field and sweet), peanut, pepper, potato, sweet potato, sorghum, soybean, squash, tomato, turnip, and watermelon fields as part of the U.S. Department of Agriculture witchweed control program.

Atmospheric Standards

This action promulgates standards of performance for equipment leaks of Volatile Organic Compounds (VOC) in the Synthetic Organic Chemical Manufacturing Industry (SOCMI). The intended effect of these standards is to require all newly constructed, modified, and reconstructed SOCMI process units to use the best demonstrated system of continuous emission reduction for equipment leaks of VOC, considering costs, non air quality health and environmental impact and energy requirements. Ethylene is produced, as an intermediate or a final product, by process units covered under this subpart.

What EU regulatory requirements apply to Ethylene vinyl alcohol?

3 regulations

REACH Registered Substance

Status: Active Update: 17-05-2023 https://echa.europa.eu/registration-dossier/-/registered-dossier/16094

EFSA Legal Basis

Regulation (EC) No 1935/2004 (amended)

Status Regulation (EC)

Reg. (EU) 2022/708, 2008/127/EC, Reg. (EU) 2017/195, Reg. (EU) 2018/155, Reg. (EU) 2023/1446, Reg. (EU) No 187/2013, Reg. (EU) No 540/2011

What regulations apply to Ethylene vinyl alcohol in Canada?

1 regulation

DSL / NDSL

Published
04 May 1994
Effective
04 May 1994

Regulatory records

EntryRegulationTypeStatus
74-85-1SOR/94-311DSLauthorized

Conditions

This substance is on the Domestic Substances List (DSL). This substance was added to the DSL as an “Existing Substance” given that it meets the criteria set out in CEPA for substances that were in commerce in Canada between 1984 and 1986.

Record details

SOR/94-311

professional use only
No

What regulations apply to Ethylene vinyl alcohol in Australia?

1 regulation

The Australian Inventory of Industrial Chemicals

Chemical: Ethene

What regulations apply to Ethylene vinyl alcohol in New Zealand?

1 regulation

New Zealand EPA Inventory of Chemical Status

Ethene (ethylene): HSNO Approval: HSR001001 Approved with controls

Which United States federal regulations apply to Ethylene vinyl alcohol?

1 regulation

New Jersey Worker and Community Right to Know Act

The New Jersey Worker and Community Right to Know Act requires public and private employers to provide information about hazardous substances at their workplaces. (N.J.S.A. 34:5A-1 et. seq.)

Which conditions, limits, and use contexts most affect a compliance assessment for ethylene vinyl alcohol?

Key conditions affecting compliance include GHS classification, occupational exposure limits, and use-specific exemptions. Ethylene is classified as an extremely flammable gas (H220), a gas under pressure (H280), and may cause drowsiness (H336), with some notifications indicating aquatic toxicity (H402, H412). The ACGIH TLV is 200 ppm as an 8-hour TWA, with a peak exposure recommendation not exceeding three times the TLV for more than 15 minutes. In the US, ethylene is exempt from pesticide tolerance requirements when used as a plant regulator under good agricultural practices. For food-contact materials, specific FDA regulations (e.g., 21 CFR 177.1310) define conditions of use.

What should be in place before a product containing ethylene vinyl alcohol is assessed for launch?

Before launch, a compliance assessment should confirm the substance's regulatory status in each target market, including REACH registration in the EU, TSCA active status and CDR reporting in the US, and inventory listing in Australia and New Zealand. For food-contact products, verify that the specific FDA regulation (e.g., 21 CFR 177.1310) covers the intended use and that any applicable conditions are met. For pesticide uses, confirm the product is registered with EPA and that tolerance exemptions apply. Also, ensure GHS classification and labeling are current, and that occupational exposure limits are considered in safety data sheets.

Where does the available regulatory position stop short of supporting a decision on ethylene vinyl alcohol?

The available regulatory position stops short of supporting a decision on ethylene vinyl alcohol because the evidence pertains to ethylene, not the copolymer. No specific regulations, exposure limits, or food additive approvals are provided for ethylene vinyl alcohol itself. The REACH registration and TSCA active status apply to ethene, and the FDA food additive listings are for ethylene, not the copolymer. Therefore, extrapolating these findings to ethylene vinyl alcohol would be speculative. A compliance decision requires ingredient-specific data, which is not present in the supplied evidence.

Which recent regulatory changes or effective dates are material for ethylene vinyl alcohol?

Recent regulatory changes are not directly evidenced for ethylene vinyl alcohol, but for ethylene, the REACH registration was updated on 17 May 2023, indicating an active dossier. The EU has a series of regulations listed (e.g., Reg. (EU) 2022/708, 2023/1446) that may affect ethylene's status, though their specific impact is not detailed. In the US, the TSCA CDR reporting requirement is ongoing, and the DHS chemical of interest listing with a 10,000-pound threshold is current. No effective dates for new restrictions on ethylene vinyl alcohol are provided.