The Health and Safety Executive (HSE), acting as the GB CLP Agency, has published a new series of opinions concerning the mandatory classification and labelling of chemical substances in Great Britain. These opinions are a significant step in the ongoing scientific and technical evaluation of chemicals under the GB CLP Regulation, which includes a thorough examination of scientific data and an analysis of both policy and socio-economic impacts within the UK.
The recently released batch includes six GB MCL Agency Opinions, now available for public access in the GB MCL publication table, downloadable in Excel format (.xlsx). These opinions are particularly noteworthy as they reflect on substances that were part of the HSE’s Agency Technical Report, published under Article 37 of the GB CLP Regulation in November 2022.
What is the GB MCL System?
The GB Mandatory Classification and Labelling (MCL) system in the United Kingdom, managed by the Health and Safety Executive (HSE), is a comprehensive framework for classifying and labelling chemical substances. This system is crucial for maintaining safety standards and informing users about the hazards associated with various chemicals. The process of updating the GB MCL List, which is somewhat similar to the EU harmonised classification and labelling system, can involve revising existing classifications or introducing new ones.
The procedure for updating the GB MCL includes several stages:
- Submission of a GB MCL Proposal.
- Public consultation.
- Preparation of a GB MCL Technical Report.
- Impact and policy assessment.
- The GB MCL Agency Opinion.
- Recommendation and decision phase.
- Amending the GB MCL List.
Proposals for new or revised GB MCL can be initiated by GB-based businesses, competent authorities, or the HSE. In particular, GB-based manufacturers, importers, and downstream users have a legal obligation to inform the HSE if there is evidence suggesting a change in the classification of a substance, especially concerning priority hazard classes like carcinogenicity, germ cell mutagenicity, and reproductive toxicity. Fees may apply for certain types of proposals, especially those not related to priority hazard classes or regulated under specific GB regulations.
Public consultation is a key aspect of this process, allowing for a broader understanding of both the scientific and socio-economic impacts of proposed classifications. HSE conducts these consultations to gather insights into the technical aspects of the proposed classifications and their policy and socio-economic implications. The GB MCL Technical Report, drafted by HSE's regulatory scientists and specialists, is an independent evaluation of the proposed classification, focusing solely on the scientific assessment of a substance's hazardous properties. Following this, HSE also assesses the policy and socio-economic impacts of the proposed classification, consulting with stakeholders to understand the potential downstream impacts. Finally, based on the Agency Opinion, HSE makes a recommendation to the Secretary of State and other relevant ministers, leading to a decision on whether to accept the new or revised GB MCL, which is then published on the HSE website.
What Substances were Reviewed?
The substances with recently published opinions (November 2023) are as follows:
| Substance |
CAS No. |
EC No. |
| Reaction mass of N,N'-ethane-1,2-diylbis(decanamide); 12-hydroxy-N-[2-[(1-oxodecyl)amino]ethyl] octadecanamide; N,N'-ethane-1,2-diylbis(12-hydroxyoctadecanamide); [1] N,N'-Ethane-1,2-diylbis(12-hydroxyoctadecanamide)[Thixatrol plus] [2] |
n/a |
430-050-2 |
| α-methyl-1,3-benzodioxole-5-propionaldehyde [1]; (S)-α-methyl-1,3-benzodioxole-5-propionaldehyde; (2S)-3-(1,3-benzodioxol-5-yl)-2-methylpropanal [2]; (R)-α-methyl-1,3-benzodioxole-5-propionaldehyde; (2R)-3-(1,3-benzodioxol-5-yl)-2-methylpropanal [3] |
1205-17-0 [1]; 737776-68-0 [2]; 737776-59-9 [3] |
214-881-6 [1]; - [2]; - [3] |
| 2-[ethyl[3-methyl-4-[(5-nitrothiazol-2-yl)azo]phenyl]amino]ethanol [Disperse Blue 106] |
68516-81-4 |
271-183-4 |
| Propyl 3,4,5-trihydroxybenzoate |
121-79-9 |
204-498-2 |
| (3E)-dec-3-en-2-one |
18402-84-1 |
n/a |
| Acetone oxime |
127-06-0 |
204-820-1 |
Next Steps for the Recent Opinions
As of now, the proposed classifications and labels outlined in these Agency Opinions are not yet finalised or adopted within Great Britain. They represent an essential phase in the regulatory process, offering a comprehensive view of the potential impacts and scientific evidence supporting either a new or revised GB MCL for each substance.
For stakeholders and interested parties, the HSE provides detailed information on the next stages of the GB MCL system on its official webpage. Additionally, the HSE anticipates publishing the next set of Agency Opinions in December 2023 and will issue CLP ebulletin alerts when these opinions are available on the HSE website.
