Regulatory Guidance

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The CARACAL has provided more details on the ongoing study into making DMELs* mandatory when certain parameters are triggered. The study results are expected by the end of 2022. The CARACAL has indicated concerns with the concept of MAF (Mixture Assessment Factor), when used for unintentional mixtures. Concentrations regarded as safe with individual chemicals can result in adverse (eco)toxicological effects when several chemicals occur together in a mixture. The CARACAL wants to ensure that the regulatory threshold of a given chemical (PNEC/DNEL)** can be divided to ensure a level of protection against unintended mixture effects, similar to the level of protection aimed for in a single substance assessment.

The CARACAL also discussed and provided advise on the upcoming REACH revision. They would like to include more alternative methods, so called NAMs*** and introduce improvements on uses and exposure information. They would like to see a merger of the authorisation and restriction process. These processes should include both consumer and professional uses. Additional hazard classes, such as endocrine disruption, PBT, neurotoxins, immunotoxins, Respiratory Sensitisers and STOT RE, should be included.

The EU Chemical for Sustainability Strategy (CSS) calls for a “one substance, one assessment” approach. The CARACAL has established a working group to look harmonisation of commonly used tools, such as risk assessment and data entry. As part of the harmonisation, the European Commission has proposed “harmonised health based limit values” under the CLP regulation. The CARACAL considers this option to be used where appropriate and desirable.

The members of CARACAL have not been able to agree on registration criteria for polymers. A grouping option for polymers has been proposed, however the members of CARACAL have concerns the same mistakes made for UVCBs will repeated if the grouping approach is not considered correctly.

* DMELs = derived minimal effect levels
** PNEC = predicted no effect concentration
DNEL = derived no effect levels
*** NAM = new approach methodologies