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 global competitiveness of the EU chemicals industry 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 must demonstrate to the European Chemicals Agency (ECHA) how a substance can be safely used and communicate any 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 huge response from the chemical industry and its value chains in recent years.

Restriction

A restriction is used to protect human health and the environment from unacceptable risks posed by chemicals. Restrictions may limit or ban the manufacture, placing on the market, or use of a substance. In specific cases, like for diisocyanates, where the product is used in numerous applications, authorities may decide to call for the development of targeted product stewardship initiatives. These will ensure that all workers who interact directly with the substances are both informed and trained in order to manage any risks associated with their handling and close contact.

REACH Restriction on diisocyanates

BAuA, the German REACH Competent Authority (CA), took a particular interest in the respiratory sensitising properties of diisocyanates at 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 unique 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 was adopted by ECHA in December 2017.

On 4 February 2020, the REACH Committee voted in favour of the European Commission’s proposal for a REACH restriction on diisocyanates. The Restriction was published on 4 August 2020 applying from 24 August 2023 after a transition period of 3 years.

You will find below a summary of the requirements under the final legal text of the Restriction.

Under the new Restriction, suppliers of diisocyanates shall ensure that the recipient is provided with training materials and courses in the official language(s) of the Member State(s) where the substance(s) or mixture(s) are supplied. The training shall take into consideration the specificity of the products supplied, including composition, packaging, and design.

• The training will be conducted either as classroom training/virtual classroom training in house, by a consultant or by public authorities or as online training;
• The trainings may be conducted through accredited trainers;
• The user – either the employer of the user or the self-employed person - of diisocyanates must document the completion of the training;
• Each employee will have to be trained once every five years, with the content and training duration depending on the use of diisocyanates in combination with the concrete task;
• The transition period during which industry must prepare for the training requirements is 3 years as of publication in the official European Journal (24 August 2023).
• The trainings must comply with provisions set by the relevant Member State in which the user operates. Member States may continue to apply their own requirements as long as the minimum requirements of the Restriction are met.
• Training can be conducted in various ways, including off-site/on-site training courses, E-learning, integration of training into the product presentation;
• The Member States must report on their established training requirements, the number of reported cases on occupational asthma and occupational respiratory and dermal disease, any national occupational exposure levels and information on enforcement activities.

The member companies of ISOPA and ALIPA as well as trade associations of relevant downstream users worked closely together to develop the required set of training material to be available as soon as possible.

Diisocyanate manufacturers have invested in the development of a comprehensive package of training materials, which we are preparing for rollout following entry into force of the REACH Restriction.

ISOPA and ALIPA worked to educate the value-chain on the training requirements and the availability of training materials. We will also work with Member States to ensure that training materials meet their expectations and seek to promote a harmonised approach across the EU.

The Restriction specifies the level of training required for various uses of diisocyanates.

The training programme will reflect the three levels in the regulation intended for different users. Each level will have several modules with 16 foreseen in total.

The diisocyanates industry has been engaged in the regulatory process from the start 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 Risk Management Option Analysis (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 by 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.  Several downstream associations of the PU Exchange Panel are joining efforts to develop teaching materials.