ABSTRACT
Post Launch Monitoring (PLM) is one of the new approaches that are used in assessing the safety of novel foods or ingredients. It shares a close resemblance with procedures applied in the field of medicines, where Post Marketing Surveillance (PMS) has been carried out since the beginning of the 1960s. For this reason, Unilever and the Netherlands Pharmacovigilance Centre Lareb, maintaining the national reporting scheme in the Netherlands for adverse drug reactions, have been working together to optimize the Unilever's Post Launch Monitoring service. As a result of this cooperation a practical model for conducting PLM for food products has been developed. This model is also applicable for consumer products in general. The system allows for coding and assessing reports and the early detection of 'signals' of unintended health reactions. The methodological issues surrounding reporting of possible health reactions and practical issues surrounding coding and assessment of the reports that were encountered in the first period of this partnership are discussed. In addition, similarities and differences concerning PMS and PLM are described.
Subject(s)
Food Industry/methods , Food/adverse effects , Product Surveillance, Postmarketing/methods , Adverse Drug Reaction Reporting Systems , Data Collection , Food Industry/standards , Humans , Netherlands , Public Health , Risk Assessment/methods , Risk Management/methodsABSTRACT
Pseudomonas aeruginosa was able to grow in high levels of an amphoteric and a quaternary ammonium compound following repeated subculturing in increasing concentrations of the biocides. Resistance was acquired and lost gradually. Adaptation to both biocides resulted in cross resistance to biguanides but whereas quaternary adapted cells were resistant to a range of quaternary ammonium compounds, the amphoteric adapted organisms were not. Amphoteric adapted cells had increased hydrophobicity and exhibited ultrastructural modifications which suggested that the outer membrane might be involved in resistance. Both amphoteric and quaternary ammonium adapted organisms showed changes in their fatty acid profiles consistent with outer membrane modification but the changes were different in each case. The mechanisms involved in biocide resistance are discussed.
