Brainstorming opportunities for postmarketing surveillance of chemicals : Workshop report

On behalf of the Ministry of Health a survey was prepared of possibilities for setting up a 'post-marketing surveillance' (PMS)-system for chemical substances in consumer products, including food. With such a system, (long-term) health effects of substances which are already on the market may be identified. Setting up such a system was advised by the Health Council of The Netherlands (GR) based on a report from 2014. In this report, GR concluded that PMS of chemicals is warranted given that certain health effects in humans may not become visible in animal studies used for risk assessment. First, a preliminary overview of current PMS related activities in different areas of legislation, such as food, drugs and consumer products, was prepared. Existing experience in different legislative frameworks can feed into a new system. Relevant national stakeholders have contributed to the overview, and have discussed short and long-term opportunities for further development of PMS. Possible short-term options included sharing existing information, to connect different existing databases and to share new information about health effects of chemicals on an ad hoc basis. For the longer term, exposure assessment directly in humans or for example in blood samples stored in biobanks were considered. In addition, more extensive registration of the use of compounds in consumer products was advised, as well as international harmonization of PMS data collection. It was advised to establish a working group with stakeholders to expand this initiative and to exchange ad hoc information on a regular basis. stakeholders regulatory framework signaling