BDO & Derivatives

Issues and Regulations

REACH

The BDO and Derivatives REACH Consortium activities and dossiers are managed by ReachCentrum.

Voluntary Product Stewardship Code for BDO and GBL

BDO and GBL are on the Voluntary Monitoring List for Non-Scheduled Drug Precursors under the EU regulations on monitoring of trade in drug precursors. The members of the BDO & Derivatives Sector Group have all committed to a common voluntary Product Stewardship code with measures to prevent the misuse of BDO and GBL and only supply these products to credible customers with known and understood end-uses. In particular, the BDO & Derivatives Sector group does not support the sale of BDO and GBL on internet to private consumers. Since its adoption in 2005, the code has been reviewed regularly to ensure its effectiveness.

The Cefic code served a starting point for a voluntary international product stewardship code that was developed together with the American Chemistry Council (ACC), the Japan Chemistry Industry Association (JCIA) and the China Petroleum & Chemical Industry Federation (CPCIF).  The code was adopted in April 2017 by the Internal Council of Chemical Associations (ICCA) and is perceived as a best practice example in the field of responsible care and product stewardship. The next step is now to spread these practices to manufacturing companies all over the world by having them endorse the code.

Recent developments on 1-methyl-2-pyrrolidone (NMP)

• In April 2020, The BDO Sector Group under the umbrella of Petrochemicals Europe organised a one-hour webinar in cooperation with the European Chemicals Agency (ECHA) to explain the N-Methyl Pyrrolidone (NMP) guideline. The recording of the webinar is available HERE. The presentations of the speakers can be downloaded: Philip de Smedt, Cefic, Petteri Mäkelä, ECHA, Christiaan Fetter, Lyondell Chemie and Renske Beetstra, Dutch National Institute for Public Health and the Environment (RIVM). Following on from the webinar, the speakers prepared a Q&A to answer further questions from NMP users.
• In April 2018, the European Commission published a restriction (Regulation (EU)/2018/588) for NMP.  The restriction establishes DNELs for exposure of workers to NMP via both the inhalation and the dermal routes and is seen as the most appropriate Union-wide measure to address that risk. All downstream users of NMP have until 9 May 2020 (9 May 2024 for the wire winding sector) to implement the restriction. ECHA developed a guideline with the help of Petrochemicals Europe to give practical advice on how the risk for workers can be adequately controlled and monitored. To develop this guideline, ECHA organised a public consultation and a workshop with selected industry representatives. The BDO Sector Group and Petrochemicals Europe as umbrella association hosting NMP producers and several users´ groups were involved and fully supportive of this initiative.

Background:

• In 2013, the competent authority of the Netherlands submitted a restriction dossier on NMP to ECHA. Subsequently, in December 2014, a joint Opinion of the Committee for risk assessment (RAC) and the Socio economic analysis Committee (SEAC) advised the EC to put forward an amended restriction for NMP as the best management option.
• The joint RAC and SEAC Opinion defines a harmonised “Derived No Effect Level (DNEL)” for workers of 10 mg/m³ for inhalation to be used to assess and define risk minimisation measures in occupational exposure scenarios. However, the recommendation was below the valid occupational exposure level for NMP of 40 mg/m³ implemented by the EU Directive 2009/169. Therefore, in December 2014, the EC urged RAC and the scientific committee on occupational exposure levels (SCOEL) to find a compromise on the basis of article 95 (3) of the REACH regulation 1907/2006 (*).
• On 30 November 2016, the parties acknowledged that they were unable to reach an agreement on a common position. The Cefic BDO & Derivatives sector group understands and respects the scientific grounds of every stakeholder. However, the lack of clarity on an effective DNEL significantly increases the uncertainty about the future use of NMP. Industry investments and market decisions have already been postponed since the EC’s decision of December 2014. Further delay on a decision on an amended restriction will lead to even more economic damage for producers and industry consumers.
• The Cefic BDO & Derivatives sector group urges the EC to overcome this period of regulatory uncertainty and to come to a final conclusion in order to pursue the NMP restriction process by amending Annex XVII of Reach, as proposed in the Dutch competent authorities.
• On 2 March 2017, ECHA added NMP to the Draft Recommendation of Priority substances to be included in Annex XIV (authorisation list). There was an extensive participation from the industry to the public consultation, that was split into two parts.  One launched by ECHA on the authorisation proposal itself, and the other one by the EU commission on the socio-economic analysis of adding NMP to the authorisation list. None of them support the authorisation proposal. The results of this public consultation will be discussed at the CARACAL meeting mid November.
• Mid July 2017, the European commission prepared a restriction proposal that was submitted to the Committee on Technical Barriers to Trade for consultation of WTO. This proposal was discussed for the first time at the REACH committee meeting on 28 September and a second time on 24 October, where the proposal was voted with 24 member states supporting the restriction proposal, 2 voting against and 2 member states abstaining.
• NMP would be restricted in the following scenarios: (a) from being placed on the market to the general public as a substance on its own or in mixtures in a concentration equal to or greater than 0,3% two years after the entry into force of the Restriction unless manufacturers, importers and downstream users have included in the relevant chemical safety report and safety data sheets, Derived No-Effect Levels (DNELs) relating to exposure of workers of 14,4 mg/m³ for exposure by inhalation and 4,8mg/kg/day for dermal exposure; (b) from being manufactured, or used, as a substance on its own or in mixtures in a concentration equal to or greater than 0,3% two years after the date of entry into force of the Restriction unless manufacturers and downstream users take the appropriate risk management measurers and provide the appropriate operational conditions to ensure that exposure of workers is below DNELs of par. (a).
• On 13 October 2017, European Commission decided to add DMF and two other aprotic solvents (NMP and DMAC) to the PACT –RMOA list. At this stage, the BDO SG believes that the results of this RMOA will be discussed at the ECHA RIME meeting in February 2018.
• Neither the EU Parliament nor the EU Council submitted an objection to the NMP restriction proposal made by the European Commission. The deadline to object was on 27 January 2018. Therefore the Commission restriction proposal will automatically become law. On 19 April,the European Commission published the legislative text on restriction for NMP.
• Protection of workers against occupational health risks is one of the priorities of the European Commission and there are concerns that professional users such as car repair shops or cleaning companies lack the necessary expertise to implement the restriction proposal. Therefore, NMP producers have decided to exclude professional use of NMP from their MSDS and the REACH dossier.
• If industrial downstream users are able to demonstrate that the restriction proposal is able to achieve its goal to protect workers, the BDO sector group is confident that this will stop further discussion on the authorization of NMP.