Flavouring Group Evaluation 52 (FGE.52): Consideration of hydroxy‐ and alkoxy‐substituted benzyl derivatives evaluated by JECFA (57th meeting) structurally related to benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters evaluated by EFSA in FGE.20 (2005) (Commission Regulation (EC) No 1565/2000 of 18 July 2000) ‐ Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food (AFC)

,

doi:10.2903/j.efsa.2008.637

EFS2

2008

DOI: 10.2903/j.efsa.2008.637

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Flavouring Group Evaluation 52 (FGE.52): Consideration of hydroxy‐ and alkoxy‐substituted benzyl derivatives evaluated by JECFA (57th meeting) structurally related to benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters evaluated by EFSA in FGE.20 (2005) (Commission Regulation (EC) No 1565/2000 of 18 July 2000) ‐ Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food (AFC)

Abstract: The present consideration concerns 44 hydroxy-and alkoxy-substituted benzyl derivatives evaluated by JECFA (57 th meeting) and will be considered in relation to the European Food Safety Authority (EFSA) evaluation of 35 benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters evaluated in the Flavouring Group Evaluation 20 (FGE.20). The Panel concluded that the 44 substances in the JECFA flavouring group of hydroxy-and alkoxysubstituted benzyl derivatives are structurally related to … Show more

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Cited by 3 publications

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A perspective on the safety of parabens as preservatives in wound care products

Torfs¹,

Brackman²

2020

International Wound Journal

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Antimicrobial and/or preservative ingredients incorporated in wound care products are subjected to certain safety restrictions. However, several of those agents, and paraben preservatives in particular, have been criticised. Conflicting reports on the potential of parabens to induce allergic contact dermatitis, and their assumed oestrogen-like activity, raised public health concerns about their overall safety. Here, we seek to provide a balanced perspective on the most significant purported adverse health effects, and thereby allay the many misconceptions regarding the safety of parabens. Extensive and long-term monitoring of paraben allergy frequencies illustrate that allergic reactions are quite uncommon, especially when compared with other antimicrobial and preservative agents. The estrogenic potential of parabens was illustrated to be far less potent than that of natural oestrogen receptor ligands, and the etiological significance of their presence in human tissue has not been established. The general consensus based on investigations by both the scientific community and regulatory agencies indicates that, with current safety regulations regarding their use in place, this effective and well-documented group of preservatives should not warrant drastic measures to replace them. As such, despite the ongoing concern, it is indicated that, when used at typical concentrations, parabens are unlikely to affect human health.

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A perspective on the safety of parabens as preservatives in wound care products

Torfs¹,

Brackman²

2020

International Wound Journal

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Safety of orthosilicic acid‐vanillin complex (OSA‐VC) as a novel food ingredient to be used in food supplements as a source of silicon and bioavailability of silicon from the source

Younes¹,

Aggett²,

Aguilar³

et al. 2018

EFS2

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The present scientific opinion deals with the safety of orthosilicic acid‐vanillin complex (OSA‐VC) as a novel food ingredient for use as a source of silicon (Si) in food supplements and with the bioavailability of Si from this source. OSA‐VC is stable in liquid solution at low pH values. OSA from OSA‐VC was available as revealed by the increase in plasma Si concentrations after oral ingestion in human volunteers. The toxicological data provided in support of the current application were not in accordance with the Tier 1 requirement of the ‘Guidance for submission for food additive evaluations’; however, this was considered justified by the Panel given that OSA‐VC at pH 6.8 dissociates into orthosilicic acid and vanillin. The daily consumption of OSA‐VC at the dose recommended by the applicant would provide a supplemental intake of Si of approximately 10–18 mg Si/day which would result in an estimated total intake of roughly 30–70 mg Si/day. The maximum vanillin intake resulting from the consumption of OSA‐VC would be less than 5% of the acceptable daily intake (ADI) value for vanillin of 10 mg/kg body weight (bw) per day established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 2002. The Panel concluded that there would be no safety concern with the proposed use and use level of OSA‐VC as a novel food ingredient intended to be used as a source of Si in food supplements for the adult population. The Panel concluded that OSA, measured as Si, is bioavailable following ingestion of OSA‐VC and appears similar to values reported in the literature for other established sources of OSA.

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Scientific opinion on Prosmoke BW 01

Younes¹,

Aquilina²,

Castle³

et al. 2022

EFS2

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The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of Prosmoke BW 01 as a new smoke flavouring primary product, in accordance with Regulation (EC) No 2065/2003. Prosmoke BW01 is produced by pyrolysis of beechwood (Fagus sylvatica L.) sawdust. Its water content is estimated at 56 wt%, the total identified volatile fraction accounts for 28 wt% of the primary product, corresponding to 64% of the solvent‐free mass, while the unidentified fraction amounts to 16 wt% of the primary product. Analytical data provided for three batches demonstrated that their batch‐to‐batch‐variability was sufficiently low. However, for the batch used for the toxicological studies, there were substantial deviations in the concentration of nearly all the constituents compared to the other three batches. The dietary exposure of Prosmoke BW 01 was estimated to be between 6.2 and 9.2 mg/kg body weight (bw) per day, respectively, using SMK‐EPIC and SMK‐TAMDI. Using the FAIM tool, the 95th percentile exposure estimates ranged from 3.2 mg/kg bw per day for the elderly to 17.9 mg/kg bw per day for children. The Panel noted that furan‐2(5H)‐one is present in all batches of the primary product at an average concentration of 0.88 wt%. This substance was evaluated by the FAF Panel as genotoxic in vivo after oral exposure. The Panel considered that the (geno)toxicity studies available on the whole mixture were not adequate to support the safety assessment, due to limitations in these studies and because they were performed with a batch which may not be representative for the material of commerce. Considering that the exposure estimates for furan‐2(5H)‐one are above the TTC value of 0.0025 μg/kg bw per day (or 0.15 μg/person per day) for DNA‐reactive mutagens and/or carcinogens, the Panel concluded that Prosmoke BW 01 raises a concern with respect to genotoxicity.

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Cited by 3 publications

References 94 publications

A perspective on the safety of parabens as preservatives in wound care products

A perspective on the safety of parabens as preservatives in wound care products

Safety of orthosilicic acid‐vanillin complex (OSA‐VC) as a novel food ingredient to be used in food supplements as a source of silicon and bioavailability of silicon from the source

Scientific opinion on Prosmoke BW 01

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