BDO & Derivatives
The BDO & Derivatives Sector Group
The BDO & Derivatives Sector Group deals with 1,4 butanediol (BDO), and its downstream products such as gammabutyrolactone (GBL), tetrahydrofuran (THF), N-methylpyrrolidone (NMP), N-ethylpyrrolidone (NEP) and 2-pyrrolidone (PYR). The group takes care of the regulatory environment of these chemicals and strives to maintain a high level of product safety by appropriate measures. This includes a social responsibility for potential misuse of these bulk chemicals.
Uses and properties
BDO, GBL and PYR, predominantly serve as building blocks in the production of other chemicals or engineering plastics and polyurethane systems (e.g. golf balls, skateboard wheels, car bumpers). THF, NEP and NMP are essential process solvents in the production of circuit boards, insulated wire, membranes and lithium ion batteries. Furthermore they are solvents for inks, lacquers, adhesives and chemical synthesis of pharmaceutical active ingredients THF, apart from its solvent use, is the monomer of Poly THF the principal material for the manufacture of elastic fibers and other high performance polymers.
Issues and regulations
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.
Recent developments on 1-methyl-2-pyrrolidone (NMP)
- 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 harmonized “Derived No Effect Level (DNEL)” for workers of 10 mg/m³ for inhalation to be used to assess and define risk minimization 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. The responses to the public consultations can be found on here. 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, 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.
Philip de Smedt, Sector Group Manager
Tel. + 32 2 676 7272
Chairman: Vasilios Galanos, BASF.