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Food for thought … why no new in vitro tests will be done for REACH by registrants

2010; Springer Nature; Linguagem: Inglês

10.14573/altex.2010.3.175

1868-8551

Costanza Rovida,

Agricultural safety and regulations

ReACH is the new european Regulation for the assessment of both toxicological and eco-toxicological risks related to chemicals. It is the most challenging system for chemical safety ever implemented worldwide. the basis for the development of this important regulation was the increasing awareness that thousands of chemicals commonly circulate in the european Union in spite of little knowledge about their (eco)toxicological properties (White Paper, 2001). the increasing incidence of allergic reactions, some tumours, fertility impairment and other diseases contributed to rising concern about the role of chemicals in our daily lives (european Risk Observatory Report, 2009). According to ReACH, all substances that are marketed in the european Union at more than one tonne per year need to be registered by presenting an extensive dossier to the european Chemical Agency (eCHA) located in Helsinki. the extent of this dossier depends on the tonnage band of the manufactured/ imported substances, being very demanding for chemicals circulating above 1000 t/year and less so for thresholds of 100, 10 and 1 t/year. tables 1a-c summarise all data that need to be submitted according to the different Annexes of ReACH. ReACH requirements are not limited to a general characterisation of the physico-chemical and (eco)toxicological properties. the dossier must include information about the whole lifecycle of the substance and should be completed with a detailed description about how the chemical is handled, how it is used, how it is disposed of, which are the risk management measures that are implemented and so on. For all chemicals that are distributed in quantities above 10 t/year, the dossier must include a more extensive Chemical Safety Assessment (CSA) and in case the chemical is classified, the CSA must comprehend a very detailed exposure scenario for workers, consumers and the environment. the delivery of the CSA is part of the Chemical Safety Report (CSR), which is attached to the submission file. the complexity of the registration dossier needs many different professional skills, ranging from chemistry, toxicology, analytical skills, occupational safety and health, and so on. But these are not the only difficulties. REACH introduces the rule of “one substance, one registration”, forcing all parties who are interested in the registration of a given substance to join what is called a SIeF (Substance Information exchange Forum). the dimensions of a SIeF range from 2-4 companies up to several hundred, typically located in different eU countries. the participants of a SIeF are de facto competitors and day-to-day relationships in the SIeF are generally very difficult, as the participants must agree on a common CSA and share registration costs. this is the level on which lawyers and accountants start working. each SIeF has a lead registrant, who does most of the job, generally helped by a consultant company, which can take care of different aspects of the registration process. For the preparation of these complex and multifaceted dossiers, eCHA developed and distributed for free a very comprehensive software-tool, which is called IUClID 5.2. the starting window of IUClID 5.2 is shown in Figure 1. the use of this software is complex and probably very few people in europe have had the opportunity to learn intensively how to deal with it.