Adopted in 2006, REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation. It is a European regulation that aims at improving the protection of human health and the environment from potential risks from chemical substances; whilst ensuring the EU chemicals industry’s global competitiveness is maintained. As opposed to previous legislation, REACH places the burden of proof on industry. To comply with the Regulation, companies must correctly identify and manage risks. In turn, chemical producers have to demonstrate to the European Chemicals Agency (ECHA) how the substance can be safely used and communicate the risk management measures to their users. To deliver on such ambitious objectives, the Regulation has put in place a number of processes that have required a lot of efforts from the chemical industry and its value chains in recent years.

timeline

Diisocyanates have been subject to regulatory processes in Poland, Estonia and Germany since 2012.

Evaluation led by Poland, Slovenia and Estonia

Both TDI and MDI have been added to the ECHA Community Rolling Action Plan (CoRAP). TDI was evaluated in 2013 by the Polish Competent Authority which concluded that no regulatory action was needed.

MDI has been evaluated by Estonia since 2013 and the final conclusions are expected in the autumn of 2018, as further information was requested. HDI was evaluated by Slovenia, concluding there was no need for further action.

Restriction led by Germany

Meanwhile, BAuA, the German REACH Competent Authority, took a particular interest in the respiratory sensitising properties of diisocyanates in the workplace (if not handled properly). In order to clarify the situation and identify the best policy tool, German authorities decided to conduct a Risk Management Option Analysis (RMOA). The exercise was completed in August 2014 and Germany recommended a more original restriction route, by proposing mandatory training that would ensure safety in the workplace for workers handling diisocyanates.

In October 2015, BAuA formally registered its intention to prepare a restriction dossier. The dossier was formally sent to ECHA in October 2016 and has since then been subject to scrutiny by ECHA’s Committee for Risk Assessment (RAC) and Committee for Socio-Economic Analysis (SEAC), including public consultations on their opinions. The final draft restriction dossier compiling the RAC and SEAC opinions as well as the comments received during the public consultation was published on 18 May 2018 (click here). The Commission is due to put forward a proposal before the end of 2018.

Scope of the Restriction

concentration

Training

An EU harmonised set of training materials will be provided by diisocyanate manufacturers and importers in cooperation with downstream users;

  • The trainings will be conducted in house, by a consultant or by public authorities. It can be conducted in various ways, including off-site/on-site training courses, E-learning, integration of training into the product presentation;
  • The trainings will be conducted through train-the-trainer principle;
  • Users of diisocyanates will have to document the completion of the training and check the validity once per year;
  • Each employee will have to be trained once every four years, content and training duration depending on the risk of exposure;
  • There will be a transition period of several years during which industry must get ready for the restriction and workers will start being trained. The exact duration of this transition period will be the subject of political discussion at the end of the regulatory process. The proposed transition period by RAC and SEAC is 4 years;

Manufacturers and importers, as well as trade associations of relevant downstream users, have already indicated their commitment to such an approach and have started internal consultations in developing such training materials.

training levels

Proposed Training Structure

Exemption

The restriction dossier will also contain a procedure allowing industry to demonstrate that product-use combinations inherently carry no significant exposure. In this case, such product-use combinations will be exempted from the need for training. We also understand training materials will be made available by the placers of diisocyanates on the market.

 

Evaluation

BAuA as the initiator of the restriction is very interested to evaluate the success of the proposed Restriction. Industry supports this view. There are short, mid and long-term measures to evaluate the success such as the number of workers that undertook the training, successful passed exams are more short to midterm KPI`s.

The diisocyanates industry has been engaged in the regulatory process right from the beginning in order to provide authorities with the most robust data and information and to permit REACH regulators to have a pragmatic and harmonised approach, which could be applicable to all companies, including SMEs.

Following BAuA’s RMOA on diisocyanates in 2014, ISOPA and ALIPA decided to further cooperate with downstream associations in the context of REACH-related issues. They actively provide relevant information to authorities conducting research on diisocyanates in a newly created platform, the Polyurethane (PU) Exchange Panel. The Panel’s goal is to allow the entire value-chain to better participate in the process with all relevant REACH Competent Authorities in Europe.

Further to the obligation to develop training material, ISOPA, ALIPA and nine downstream sector association have joined efforts and are putting together the training material. In addition to ISOPA and ALIPA, the signatory parties of the Memorandum of Understanding for the development of teaching materials include:

  • PDA Europe small
    PDA Europe - Polyurea Development Association Europe
  • fsk logo freigestellt Neu August 2018
    FSK - Fachverband Schaumkunststoffe und Polyurethane e. V.
  • CEPE logo
    CEPE - European Council of the Paint, Printing Ink and Artists’ Colours Industry
  • europur ND
    EUROPUR - Association Européenne des Producteurs de Mousse Polyurethane Flexible
  • Feica RGB
    FEICA - Association of the European Adhesive & Sealant Industry
  • pu europe
    PU-Europe - Federation of European Rigid Polyurethane Foam Associations
  • EFCC logo
    EFCC - European Federation for Construction Chemicals
  • ICOMIA
    ICOMIA - International Council of Marine Industry Associations
  • OnderhoudNL
    Koninklijke OnderhoudNL