Recommendation for an OEL for an Active Pharmaceutical Ingredient (API)

Recommendation for an OEL for an Active Pharmaceutical Ingredient (API)

Client A global contract developer and manufacturer of pharmaceutical products Background The use of Occupational Exposure Limits (OELs) to protect workers from potential adverse health effects arising through their handling of chemicals in the workplace is a long-established tool for industrial hygienists. Working in the…

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Human health risk assessment for professional use of a veterinary product

Human health risk assessment for professional use of a veterinary product

Client A partner consultancy providing support to a European company active in the Biocidal Products, Plant Protection Products and Veterinary Products markets. Background The application and use of veterinary products may be undertaken by both professionals (e.g. veterinarians or farmers) and non-professionals (the general public)….

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Literature monitoring for various industry sector groups

Literature monitoring for various industry sector groups

Clients A number of European chemistry industry trade sector groups. Background Organisations representing specific chemical sector groups provide services to their members including keeping them up to date on new scientific literature that may impact on the status of their products. Staying abreast of the…

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Critical peer review of OECD SIDS Initial Assessment Reports (SIARs)

Critical peer review of OECD SIDS Initial Assessment Reports (SIARs)

Client Health Canada Background A SIDS Initial Assessment Report (SIAR) summarises the key scientific data on a chemical or category of chemicals. It is commonly drafted by a company or group of companies, using data from the corresponding SIDS (Screening Information Data Set) Dossier. The…

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Toxicological support to a major European hygiene company on registration of a novel biocidal active for use in the food industry

Toxicological support to a major European hygiene company on registration of a novel biocidal active for use in the food industry

Client A European hygiene company supporting the food and beverage industry Background Within the EU, biocidal products are regulated under the Biocidal Products Directive (98/8/EC). The regulatory regime will ultimately require all biocidal products to be authorised before they can be placed on the EU…

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Supporting a number of consortia on all aspects of their 2010 REACH registration obligations

Supporting a number of consortia on all aspects of their 2010 REACH registration obligations

Client A number of Consortia representing various sectors of industry. Background Manufacturers or importers into the EU of high tonnage substances (≥1000 tonnes/year) and/or hazardous chemicals (i.e. CMRs produced at ≥ 1 tonne/yr, or those considered very dangerous to the environment and produced at ≥…

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Risk assessment of a new additive for a soft drink – possible health risks for a single exposure to tasting panel members

Risk assessment of a new additive for a soft drink – possible health risks for a single exposure to tasting panel members

Client An industry client Background A drinks company was interested in developing a new additive for a soft drink. Bibra was asked to give an opinion on the possible health risks for members of a tasting panel involved in a sensory analysis trial, in which…

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Provision of expert information on the tolerability of predicted doses of impurities in specified generic pharmaceutical products

Provision of expert information on the tolerability of predicted doses of impurities in specified generic pharmaceutical products

Client A large generics Pharmaceutical company Background Generic pharmaceuticals are often manufactured using methods different from those of the patented brand, and this can lead to a different impurities profile. Regulatory submissions have to address any novel impurities, as well as any common impurities present…

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Providing expert support to a large precious metals consortium on all mammalian toxicological issues for their REACH registration

Providing expert support to a large precious metals consortium on all mammalian toxicological issues for their REACH registration

Client Consortium of metal industry companies Background Manufacturers or importers of chemicals into the European Union are required under REACH to submit a dossier of information on the substances to ECHA by tonnage-dependent deadlines. The substantial package includes relevant toxicological data, with minimum data endpoint…

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Ongoing assessments of ‘safety-in-use’ for the consumer product range of a major global organisation

Ongoing assessments of ‘safety-in-use’ for the consumer product range of a major global organisation

Client A global producer of a range of well-known consumer products. Background Bibra scientists were asked to provide ongoing in-house support within the product safety division at the UK headquarters and main manufacturing plant based in the South-East of England. Project goals Acting as an…

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