ChemRegs Newsletter – August 2023
Diisocyanates restriction has come into force
Diisocyanates are respiratory and skin sensitisers. They are mainly used as chemical building blocks to make polyurethane products in a wide range of sectors and applications, in particular in foams, sealants and coatings.
In October 2016, Germany submitted to the European Chemicals Agency (ECHA) a REACH Annex XV dossier, in order to initiate the restriction procedure set out in Articles 69 to 73 of REACH. The Annex XV dossier indicated that respiratory sensitisation, due to both dermal and inhalation exposure to diisocyanates, leads to occupational asthma in workers, which has been identified as a significant occupational health problem. Restricting their use is estimated to prevent over 3000 new cases of occupational asthma a year in the EU and UK.
The restriction proposal was supported by ECHA’s scientific committees and the Annex XV dossier demonstrated that action was necessary. It proposed to restrict the industrial and professional use, as well as the placing on the market, of diisocyanates on their own, and as constituent of other substances and in mixtures.
The restriction proposed in the Annex XV dossier was considered and adopted via Regulation (EU) 2020/1149 in August 2020 and given a 48 month deferral for application in order to provide sufficient time for the full implementation of the restriction requirements. Placing on the market has already been restricted since 24 February 2022 and the rest of the restriction has now come into force.
This means that diisocyanates cannot be used on their own or as a constituent in other substances or in mixtures for industrial and professional uses in concentrations equal or above 0.1 % by weight after 24 August 2023, unless the user has successfully completed a training on the safe use of the substance.
This restriction was also ‘cut and paste’ and adopted into UK legislation and the UK wording is as follows.
UK REACH Restriction Entry 74 – Diisocyanates, O = C=N-R-N = C=O, with R an aliphatic or aromatic hydrocarbon unit of unspecified length
Conditions of restriction:
- Shall not be used as substances on their own, as a constituent in other substances or in mixtures for industrial and professional use(s) after 24 August 2023, unless:
(a) the concentration of diisocyanates individually and in combination is less than 0.1 % by weight, or
(b) the employer or self-employed ensures that industrial or professional user(s) have successfully completed training on the safe use of diisocyanates prior to the use of the substance(s) or mixture(s). - Shall not be placed on the market as substances on their own, as a constituent in other substances or in mixtures for industrial and professional use(s) after 24 February 2022, unless:
(a) the concentration of diisocyanates individually and in combination is less than 0.1 % by weight, or
(b) the supplier ensures that the recipient of the substance(s) or mixture(s) is provided with information on the requirements referred to in point (b) of paragraph 1 and the following statement is placed on the packaging, in a manner that is visibly distinct from the rest of the label information: ‘As from 24 August 2023 adequate training is required before industrial or professional use’. - For the purpose of this entry ‘industrial and professional user(s)’ means any worker or self-employed worker handling diisocyanates on their own, as a constituent in other substances or in mixtures for industrial and professional use(s) or supervising these tasks.
- The training referred to in point (b) of paragraph 1 shall include the instructions for the control of dermal and inhalation exposure to diisocyanates at the workplace without prejudice to any national occupational exposure limit value or other appropriate risk management measures at national level. Such training shall be conducted by an expert on occupational safety and health with competence acquired by relevant vocational training. That training shall cover as a minimum:
(a) the training elements in point (a) of paragraph 5 for all industrial and professional use(s).
(b) the training elements in points (a) and (b) of paragraph 5 for the following uses:
— handling open mixtures at ambient temperature (including foam tunnels);
— spraying in a ventilated booth;
— application by roller;
— application by brush;
— application by dipping and pouring;
— mechanical post treatment (e.g. cutting) of not fully cured articles which are not warm anymore;
— cleaning and waste;
— any other uses with similar exposure through the dermal and/or inhalation route;
(c) the training elements in points (a), (b) and (c) of paragraph 5 for the following uses:
— handling incompletely cured articles (e.g. freshly cured, still warm);
— foundry applications;
— maintenance and repair that needs access to equipment;
— open handling of warm or hot formulations (> 45 °C);
— spraying in open air, with limited or only natural ventilation (includes large industry working halls) and spraying with high energy (e.g. foams, elastomers);
— and any other uses with similar exposure through the dermal and/or inhalation route. - Training elements:
(a) general training, including on-line training, on:
— chemistry of diisocyanates;
— toxicity hazards (including acute toxicity);
— exposure to diisocyanates;
— occupational exposure limit values;
— how sensitisation can develop;
— odour as indication of hazard;
— importance of volatility for risk;
— viscosity, temperature, and molecular weight of diisocyanates; — personal hygiene;
— personal protective equipment needed, including practical instructions for its correct use and its limitations;
— risk of dermal contact and inhalation exposure;
— risk in relation to application process used;
— skin and inhalation protection scheme;
— ventilation;
— cleaning, leakages, maintenance;
— discarding empty packaging;
— protection of bystanders;
— identification of critical handling stages;
— specific national code systems (if applicable);
— behaviour-based safety;
— certification or documented proof that training has been successfully completed
(b) intermediate level training, including on-line training, on:
— additional behaviour-based aspects;
— maintenance;
— management of change;
— evaluation of existing safety instructions;
— risk in relation to application process used;
— certification or documented proof that training has been successfully completed
(c) advanced training, including on-line training, on:
— any additional certification needed for the specific uses covered;
— spraying outside a spraying booth;
— open handling of hot or warm formulations (> 45 °C);
— certification or documented proof that training has been successfully completed - The training:
(a) must comply with any other requirenments contained in any other legislation that relate to the delivery of the training elements refered to in paragraph 5 and
(b) is in addition to any other training required by any other legislation. - The supplier referred to in point (b) of paragraph 2 shall ensure that the recipient is provided with training material and courses pursuant to paragraphs 4 and 5. The training shall take into consideration the specificity of the products supplied, including composition, packaging, and design.
- The employer or self-employed shall document the successful completion of the training referred to in paragraphs 4 and 5. The training shall be renewed at least every five years.
- The Agency shall include in its report pursuant to Article 117(2) the following information:
(b) the number of cases of reported and recognised occupational asthma and occupational respiratory and dermal diseases in relation to diisocyanates;
(d) information about enforcement activities related to this restriction. - This restriction shall apply without prejudice to other legislation on the protection of safety and health of workers at the workplace.
Safer transport of dangerous goods. Dangerous Goods Safety Advisors’ (DGSA) experiences with learning from incidents and near misses.
The Netherlands has released a report on near misses in the transport of dangerous goods, which found that more can be done to learn from these events and prevent future incidents.
The May 2023 report, titled “Safer transport of hazardous substances by learning from incidents” was commissioned by the Dutch Ministry of Infrastructure and Water Management and published by the Dutch National Institute for Public Health and the Environment (RIVM).
Incidents or near misses can occur when dangerous goods are transported by rail, road or inland waterways. This can affect the environment, the company involved, workers and local residents. That is why it is important to prevent such incidents from occurring. This can be done by learning more from incidents and near misses with this type of transport. There is a learning process model for this purpose, which consists of reporting, investigating, identifying actions, communicating them and evaluating the results. RIVM has consulted with DGSAs to identify how companies handle this process.
For the report, the following definitions have been used for an incident and a near miss:
• An incident is a sudden unintended event during the transport (including packaging, loading, filling or unloading) of dangerous goods. There was an uncontrolled release of a hazardous substance that could result in personal injury, damage to the environment and/or damage to company assets.
• A near miss is a situation that could have led to an incident, but ultimately did not. There was therefore no uncontrolled release of a hazardous substance. Also, no injuries or damage occurred.
The choice of the term incident and the definitions used is the result of discussions with interested parties and a number of DGSA. The report also looked at near misses. Both incidents and near misses are preceded by similar sets of failure causes and only the presence or absence of defence and recovery mechanisms determines the actual outcome (e.g. normal situation, near miss or incident). (Drupsteen et al., 2013). Near misses occur more often, as evidenced by discussions with interested parties. Learning from near misses can therefore contribute to preventing incidents in the future.
Since 2000, companies involved in the transport, storage and shipment of dangerous goods have been legally obliged to engage a DGSA, who has various obligations in ADR on the reporting and investigation of incidents (ref ADR/RID 1.8.3.3). One of these obligations includes performing analysis and – if necessary – drawing up reports on incidents during the transport process of dangerous goods. Another task concerns the introduction of appropriate measures to prevent incidents from happening again. The expectation is therefore that the person who fulfills the role of DGSA within a company will also have an idea of whether and how lessons are learned from incidents, to identify factors that hinder learning (bottlenecks), which bottlenecks are experienced in practice, and which points for improvement are possible.
One bottleneck that the report found is that companies do not always report a near miss because they do not find it useful. DGSAs also indicated that they find it difficult to determine how the effectiveness of actions should be investigated. Another frequently mentioned bottleneck is that the transport chain consists of various links. This makes solving problems more complex when other parties are needed who do not always see the need for action or do not want to free up resources for this. The predominance of commercial interests over security interests is also a bottleneck within companies and within the chain.
There were also differing interpretations on the role of DGSAs in learning from incidents, dependent on the size of the company and whether the DGSA has additional roles. For example, some companies rely on a health and safety department to oversee the learning process instead of the DGSA. Also, external DGSAs often do not get told about near misses and incidents.
Many of these bottlenecks can be overcome by hearing how other DGSAs handle them. Bottlenecks experienced by one person may have already been resolved by another. The exchange of good practices can therefore improve learning from incidents in companies. Examples include devoting more attention to learning from incidents during DGSA training and encouraging companies that cooperate on transport to talk about safety more often.
RIVM makes several recommendations for improvement in the report:
• to pay attention to near misses and focus on the most frequently occurring or potentially impactful events;
• that DGSAs should communicate with each other to exchange good practice, facilitated by the association of safety advisors (VVA), trade associations or government;
• to set up a central database with incident information, similar to one already available for road transport; and
• the VVA or government should discuss the different views on the role of DGSAs and encourage external advisors to learn from incidents.
RIVM said as the study mainly focused on internal DGSAs, future research could expand to include more external DGSAs and identify ways to improve the efficacy of actions taken. It added that it could also issue the questionnaire every few years to identify trends and assess if there is any improvement.
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