A review of decision-making in the Authorisation regime of Regulation (EC) 1907/2006 REACH

Sammanfattning: Chemicals are integral to almost all sectors of society, bringing many benefits, but the sound management throughout their lifecycle is essential in order to achieve a better and more sustainable future for all. The object of this study, the Authorisation regime in EU’s REACH-regulation, is one regulatory instrument to control chemicals. It is important that decision-making is consistent, transparent and open to ensure legitimacy. This is particularly true for the control of chemicals because it is a contested policy area, where policy effectiveness does not have an objective standard of measurement. With reference to this, the aspects studied were the form and application of rules and procedures for making decisions. Overall findings are that the decision-making includes published procedures and justifications for made decisions. The studied individual decision problems are open with mandatory public consultations, allowing input and participation from interested parties. Justification for choosing decision support tools with consequent effects on outcomes is less transparent. This also applies to operationalisation of some critical concepts. There is no definite or value-free method that can be applied to measure to what extent the objectives are met in all of the various decisions in the REACH Authorisation regime. This could potentially lead to decisions based on individual’s subjective judgments. The influence of individual value-based judgments on the outcome is mitigated by having groups of persons as decision-makers, rather than individuals, and by transparency. Certain decisions include value judgments on the acceptability of risk either made by expert judgment embedded in standards and protocols or included in a formal type of assessment. The underlying assumptions regarding values are not evident in these cases. The methodology for the decision-making has developed over time, with a decision support tool introduced for prioritisation. This algorithm-based tool supports decision-making, but actual prioritisations were often based on aspects not considered in the tool. This is likely to continue to be the case, even if (as foreseen) relevant and structured information on substances becomes more readily available. The first phase in the REACH authorisation decision procedures, clarifying and defining issues, is probably the single most important phase. It can also be demanding in time and resources. The regime includes sequential decisions, where the decision-maker’s information requirements includes increasing number of aspects from the first to the last decision. Since not all substances go through the entire sequence, this is efficient in terms of use of resources to elicit information.