E-liquid emissions

E-liquid emissions

Client An EU e-liquid manufacturer. Background The Tobacco Products Directive 2014/14/EU (TPD) requires the emissions from electronic nicotine delivery systems (ENDS) to be analytically identified and quantified. Information regarding key carbonyl compounds, notably formaldehyde, acetaldehyde, acrolein, diacetyl (2,3-butanedione) and acetyl propionyl (2,3-pentanedione), “should always be…

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Electronic cigarette pre-screening

Electronic cigarette pre-screening

Client An electronic cigarette and e-liquid manufacturer. Background Each particular e-liquid flavour consists of many ingredients (usually in addition to PG and/or VG and nicotine). According to the Tobacco Products Directive (TPD2; 2014/40/EU), any ingredient that poses a risk to human health (apart from nicotine),…

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Consideration of substances of concern in a biocidal product

Consideration of substances of concern in a biocidal product

Client A regulatory consultancy, specialising in biocidal products. Background Substances of concern (SoCs) in biocidal products are defined as those substances, other than the active, which have an inherent capacity to cause an adverse effect on humans, animals or the environment and are present/produced in…

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Health risk assessment of extractables – a metallocene polyethylene sheath

Health risk assessment of extractables – a metallocene polyethylene sheath

Client A medical devices manufacturer. Background The company had commissioned extractables and headspace analyses on a metallocene polyethylene sheath that may be in transient contact with internal tissues during implantation surgery. A number of organic and inorganic substances were detected in the analysis. Project goals…

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A preliminary toxicological comparison of two structurally related compounds and a health risk assessment of a specific exposure

A preliminary toxicological comparison of two structurally related compounds and a health risk assessment of a specific exposure

Client A global tobacco company. Background The use of 3,4-dihydrocoumarin (DHC) in a cigar head paste formulation had been challenged based on its structural similarity to coumarin, banned for food additive use in several countries. Bibra was asked to compare the toxicological profiles of these…

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Risk assessment of a pipework product used for conveying food and beverages

Risk assessment of a pipework product used for conveying food and beverages

Client The Company that manufactures the pipework. Background As small amounts of the components of the pipework may migrate into any food or drink conveyed through it, the manufacturer sought reassurance that any ingested chemicals pose no unacceptable health risks to consumers. Due to confidentiality, the…

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Risk assessment of a Pharmaceutical leachable

Risk assessment of a Pharmaceutical leachable

Client A pharmaceutical company. Background Bibra was asked to evaluate the risks of adverse health effects occurring in patients exposed to a leachable in a pharmaceutical intended for subcutaneous injection. As part of this analysis, it was requested that we identify the most relevant TTC…

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Hazard assessment of a cosmetic ingredient

Hazard assessment of a cosmetic ingredient

Client A chemical supplier. Background Bibra scientists were asked to assess the health hazards associated with a polymer intended to be used in cosmetic products. Project goals To identify and review the available toxicological data to produce a report relevant to the compound’s possible effects…

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Environmental risk assessment of active pharmaceutical

Environmental risk assessment of active pharmaceutical

Client A pharmaceutical product development company Background Following MHRA feedback on a previous Marketing Authorisation submission, our client required generation of a new environmental risk assessment (ERA) for a paediatric drug product. Project goals The first stage of an ERA is to calculate the predicted…

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Environmental risk assessment for medicinal product

Environmental risk assessment for medicinal product

Client A pharmaceutical product development company. Background An environmental risk assessment (ERA) was required for national marketing authorisation of a medicinal product, according to Article 8 of EU Directive 2001/83/EC. Project goals Bibra, in partnership with an expert environmental consultancy, were requested to conduct an…

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