The European Commission has recently announced its decisions on the authorisation for the marketing and use of certain substances listed in Annex XIV to the REACH Regulation (EC) No 1907/2006. This decision, crucial for industries relying on specific chemical substances, reflects a careful balance between socio-economic benefits and the potential risks to human health and the environment.
The substance at the centre of these decisions is 2,2'-dichloro–4,4’-methylenedianiline (MOCA), a chemical known for its industrial utility, particularly in the manufacture of high-performance polyurethanes. The authorisations granted, detailed in decisions C(2023) 7460 and C(2023) 7462, cover a range of uses in sectors from steel and aluminium to offshore energy and renewables, as well as in the production of various hot cast polyurethane products.
Authorisation holders
Key beneficiaries of these authorisations include Limburgse Urethane Castings NV in Belgium and Courbis Synthèse in France, alongside other European entities like Annovi S.r.l. in Italy and Dansk Elastomer A/S in Denmark. These companies have been granted permission to use MOCA under specific conditions and timeframes, with expiry dates ranging from 31 August 2028 to 31 December 2032.
The Commission's decision, made in accordance with Article 60(4) of the REACH Regulation, underscores that the socio-economic advantages of using MOCA outweigh the risks posed to health and the environment. This conclusion was reached after thorough evaluation, indicating that currently, there are no suitable alternative substances or technologies available that can match MOCA's effectiveness in these applications.
Uses and intrinsic hazards
MOCA is a substance used primarily as a curing agent in polyurethane products. However, it is important to be aware of its intrinsic hazards, especially in industrial settings where it is frequently used.
- Carcinogenicity: MOCA is classified as a Category 1B carcinogen under the EU CLP Regulation (EC) No 1272/2008. This classification is based on evidence suggesting that it can cause cancer. Prolonged or repeated exposure, particularly through direct skin contact or inhalation, increases the risk of developing cancer.
- Mutagenicity: MOCA has been identified as a mutagen, meaning it can cause genetic mutations, which might lead to cancer or other health issues. This property is particularly concerning in occupational settings where long-term exposure can occur.
- Reproductive Toxicity: There is evidence to suggest that MOCA can harm the reproductive system. This includes potential effects on fertility or harm to the unborn child.
- Skin Sensitisation: MOCA can cause allergic skin reactions (sensitization). Once sensitised to MOCA, individuals can develop allergic reactions even from very low levels of exposure.
- Respiratory Sensitization: Similar to skin sensitization, MOCA can also cause respiratory sensitisation, leading to allergic reactions in the respiratory system upon exposure.
- Toxicity After Inhalation and Ingestion: Inhalation of MOCA dust or vapours can be toxic, potentially causing damage to organs through prolonged or repeated exposure. Ingestion, although less common in occupational settings, can also be harmful.
Given these hazards, it is crucial for industries using MOCA to implement stringent safety measures and comply with any risk management measures stipulated by these authorisation decisions.
The European Commission has recently announced its decisions on the authorisation for the marketing and use of certain substances listed in Annex XIV to the REACH Regulation (EC) No 1907/2006. This decision, crucial for industries relying on specific chemical substances, reflects a careful balance between socio-economic benefits and the potential risks to human health and the environment.
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