Europe Gears Up for NMP Restriction


With the European Chemicals Agency’s (ECHA) restriction of N-methylpyrrolidone (NMP) is set to take effect this spring, the agency recently released a new guideline available for industrial users of the chemical for compliance.

The regulation was added last year to Annex XVII of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). It takes effect this May.

NMP was given a harmonised classification as a substance that “may damage an unborn child, cause serious eye irritation, cause skin irritation and may cause respiratory irritation.”

According to European Coatings, the restriction applies to the placing on the market and use of NMP, on its own or in mixtures containing equal or greater than 0.3% (weight percent NMP). The marketing and use of NMP and mixtures containing it are permitted only if exposure thresholds are met for the workers concerned.

ECHA notes that the restrictions of NMP are significant because this is the first restriction of its kind based on derived no-effect levels (DNELs), which are “derived from toxicological studies and describe the levels of exposure to a substance below which no adverse health effects are expected to occur in humans.”

For NMP, risk is deemed to be controlled if neither the DNEL for exposure by inhalation (14.4 mg/m3) nor the DNEL for dermal exposure (4.8 mg/kg bw/day) is exceeded for individual workers.

The compliance measurements are required to be included in the SDS.

In terms of the coatings industry, NMP had already been classified as a CMR substance (carcinogenic, mutagenic or toxic to reproduction), meaning that a substitution test has been “obligatory.” This restriction has heightened the pressure to sub out the chemical.

Meanwhile, in the U.S.

The comment period ended at the end of January for the draft risk evaluation of more than 30 uses of NMP. The Environmental Protection Agency said that it will use feedback received from the public comment process, along with input from the Science Advisory Committee on Chemicals, to inform the final risk evaluation for NMP.

The agency first announced that it was considering a ban of the use of NMP in January 2017, along with methylene chloride.

At the time, the EPA said health effects of NMP include developmental toxicity (e.g., fetal death or decreased infant birth weight), neurotoxicity, immunotoxicity, liver and kidney toxicity and reproductive toxicity.

The 277-page proposal regarding the chemicals called for a prohibition on the manufacture (including import), processing and distribution of these chemicals in commerce.

The agency also said at the time that it wanted to restrict the sale of small-volume products and require companies to notify retailers and others in the supply chain regarding such prohibitions, the document notes.

© iStock / Skyhobo

The comment period ended at the end of January for the draft risk evaluation of more than 30 uses of NMP. The Environmental Protection Agency said that it will use feedback received from the public comment process, along with input from the Science Advisory Committee on Chemicals, to inform the final risk evaluation for NMP.

For each of the chemicals, the EPA had identified risks of concern associated with their use in the following specified sectors:

  • Painting and decorating;
  • Floor refinishing;
  • Automotive refinishing;
  • Civilian aircraft refinishing;
  • Graffiti removal;
  • Renovations and contracting;
  • Bridge repair and repainting; and
  • Marine craft refinishing and repair.

One exemption is the chemicals usage in commercial furniture refinishing; the proposal doesn’t cover that application at this time, EPA says.

Chemical Watch outlined the two approaches presented in the proposal with regard to the solvent NMP.

“The first calls for a prohibition on the manufacture, processing and distribution of NMP in paint stripping, with downstream user notification requirements,” the report said.

“The second would instead put in place a set of restrictions to address the risks the substance poses, including: limiting the amount of NMP used in paint remover products; consumer warning labels; and workplace personal protective equipment (PPE) requirements.”

In May 2018, however, the EPA announced that it was moving forward with action on methylene chloride, not NMP.

Then, in March 2019, the EPA issued a final rule to prohibit the manufacture and importing, processing and distribution of methylene chloride in all paint removers for consumer use.

However, sales to contractors and other professionals will remain available.

That rule went into effect in November, which is when the EPA initially announced the draft risk evaluation of NMP.

If EPA’s final risk evaluation for NMP finds there are unreasonable risks associated with this chemical under any of the specific conditions of use, the agency will propose actions to address those risks within the timeframe required by TSCA.

This could include proposed regulations to prohibit or limit the manufacture, processing, distribution in the marketplace, use or disposal of this chemical, as applicable, according to the agency.

The preliminary findings of the draft risk evaluation include:

  • The EPA did not find risk to the environment, bystanders or occupational non-users, which included all the conditions of use.
  • The Agency's draft risk evaluation also found "unreasonable risks associated with acute and chronic inhalation and dermal exposure to NMP under a variety of conditions of use. EPA found that workers and consumers could be adversely affected by NMP under certain conditions of use. These initial determinations are based on a draft risk evaluation of the reasonably available information and are not EPA’s final determinations on whether this chemical presents unreasonable risks under the conditions of use. The Agency will use feedback received from the public comment and peer review processes to inform the final risk determinations."
  • Additionally, the draft risk evaluation and the initial risk determinations are not a final action on the Agency's part. "This draft represents the Agency’s preliminary conclusions, findings and determinations on NMP and will be peer reviewed by independent scientific experts. The draft risk evaluation includes input from other EPA offices as well as other federal agencies," wrote the EPA.

The EPA has a deadline of June to issue the initial set of 10 final risk evaluations.


Tagged categories: EMEA (Europe, Middle East and Africa); EPA; EPA; EU; Government; Health & Safety; Health and safety; Methylene chloride; NA; North America; Regulations; Safety

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