EU: How to Comply with NMP (1-methyl2-pyrrolidone) Restriction, Guidance Document, July 2019

A document released by ECHA intends to help those who use 1-Methyl-2-pyrrolidone (NMP) or mixtures containing NMP (C ≥ 0.3%) , to comply with the restriction requirements under the REACH Regulation. Moreover this guidance may help the authorities to understand what is expected and evaluate the compliance at a site.

NMP has a harmonised classification as toxic to / for reproduction (reproductive toxicant category 1B) and is also a respiratory, skin and eye irritant. In Europe, NMP is subject to REACH Annex XVII restriction 71. If you have to use NMP in your workplace, you need to protect anyone that could be exposed to it. This guideline is intended to help you understand what you need to do to comply with the provisions of this restriction in its own right but also against the background of your existing occupational safety and health (OSH) obligations.

The general approach described in this guideline can be applied to other aprotic solvents similar to NMP (such as DMF and DMAC), if similar REACH restrictions are introduced for other aprotic solvents. Some elements of the guideline are NMP specific (e.g. good practice examples, monitoring methods, description of uses etc.) and therefore may not be directly applicable to other substances.”

A new guideline is available for industrial users of 1-methyl-2-pyrrolidone (NMP) to help them comply with the substance’s restriction requirements. The guideline is needed because this is the first restriction of its kind that is based on Derived no Effect Levels (DNEL).

NMP is used as a solvent or surface deposition medium during manufacturing and is therefore a critical substance for various industries producing batteries, semiconductors, fibres, pharmaceuticals and wire coatings. NMP users in these sectors will have to comply with the restriction by 9 May 2020. For NMP used in wire coatings, the deadline is 9 May 2024.

In close cooperation with stakeholders, ECHA has prepared the guideline to help companies, including SMEs, to manage the risks when using NMP at industrial sites. NMP is a reproductive toxicant (may damage the unborn child), it causes serious eye and skin irritation and it may cause respiratory irritation. Several consultations and round table workshops have been organised to identify good practice and find illustrative examples on how users of NMP can control exposure to NMP and comply with the restriction.

The general approach described in this guideline can also be applied to other aprotic solvents similar to NMP, such as DMF and DMAC, if similar REACH restrictions are introduced for other aprotic solvents at a later stage.

The document can be found at this link.

EU: Towards a Sustainable Chemicals Strategy of the Union, Policy Document, June 2019

Overview

On June 26, 2019 the Council adopted conclusions on chemicals which offer political guidance on the development of a sustainable EU chemicals policy strategy. The conclusions address the topics of REACH, endocrine disruptors, nanomaterials and pharmaceuticals.

In its conclusions, the Council underlines the need to protect human health and the environment through the sound management of chemicals. It also highlights the need to improve and mainstream the chemical risk assessment and management of chemicals across EU legislation in order to increase the coherence and effectiveness of EU chemicals-related legislation.

The conclusions highlight the need to develop a relevant mechanism for coordinating the protection of vulnerable groups such as children and pregnant and breastfeeding women. This should include the introduction of consistent risk management requirements into relevant EU legislation on substances of concern, including neurotoxins and endocrine disruptors.

Ministers call for the promotion of green and sustainable chemistry and non-chemical alternatives, and for the stimulation of research and service-based business models in this regard.

The Council underlines the need to support small and medium-sized enterprises in their efforts to replace substances of concern and stresses the right to information in order to enable consumers to make informed choices.

The Council also supports the development and implementation of an early warning system at EU level for identifying new, emerging chemical risks that will allow for appropriate action to be taken to protect human health and the environment.

The Council urges the Commission to develop, without further delay, a Union strategy for a non-toxic environment, that proposes clear objectives for a comprehensive long-term sustainable EU chemicals policy. It calls upon the Commission to include in its proposal for an 8th Environment Action Programme commitments to implement the follow-up measures to the Union strategy for a non-toxic environment and to address forward looking chemical related challenges. The Council also highlights the need for sustainable financing and resourcing of the European Chemicals Agency and calls for its involvement in other legislative areas.

The conclusions also address the following topics:

  • Pharmaceuticals: The Council stresses the importance to accelerate concrete and ambitious actions to reduce the risk from pharmaceuticals and their residues to the environment.
  • REACH: The Council calls upon the Commission and ECHA to develop by December 2019 an action plan on dossier compliance for REACH. The Council also stresses the importance of improving the REACH authorisation and restriction procedures.
  • Nanomaterials: The Council requests the Commission to extend ECHA’s mandate to collect and make available research data on the characterization, the hazard and potential exposure of nanoforms of substances that were so far not registered under REACH because their yearly tonnage is below the threshold of 1 tonne/year and to regularly ask ECHA to evaluate the performance and the impact of the EU-Observatory on Nanomaterials which was launched in 2017.
  • Endocrine disruptors: The Council urges the Commission to ensure a high level of protection of human health and the environment by minimising exposure to endocrine disruptors and by stimulating substitution by safer chemicals, as far as technically and practically possible, and to provide, without undue delay, an action plan with clear and concrete measures and an ambitious timeline for doing so.