Scientific opinion on Prosmoke BW 01

Area of Science:

• Food Safety
• Toxicology
• Chemical Analysis

Background:

• Prosmoke BW 01 is a novel smoke flavouring primary product derived from beechwood sawdust.
• Its safety evaluation was requested under Regulation (EC) No 2065/2003.
• The product's composition includes water, identified volatile fractions, and an unidentified fraction.

Purpose of the Study:

• To evaluate the safety of Prosmoke BW 01 as a food additive.
• To assess potential genotoxicity risks associated with its consumption.
• To determine if batch-to-batch variability impacts safety assessments.

Main Methods:

• Analysis of three batches of Prosmoke BW 01 to assess variability.
• Toxicological studies on a specific batch of the primary product.
• Dietary exposure estimation using SMK-EPIC, SMK-TAMDI, and FAIM tools.
• Evaluation of furan-2(5H)-one concentration and comparison with the Threshold of Toxicological Concern (TTC) value.

Main Results:

• Batch-to-batch variability was generally low, but the toxicological study batch showed significant deviations.
• Dietary exposure estimates for Prosmoke BW 01 ranged from 3.2 to 17.9 mg/kg body weight per day.
• Furan-2(5H)-one, a genotoxic substance, was present in all batches at an average concentration of 0.88 wt%.

Conclusions:

• The (geno)toxicity studies were inadequate due to limitations and the use of a potentially unrepresentative batch.
• Exposure estimates for furan-2(5H)-one surpassed the TTC value for genotoxic mutagens.
• Prosmoke BW 01 raises safety concerns regarding genotoxicity.