Yesterday, the European General Court, struck down a Commission measure because no necessary Impact Assessment had been performed (link).
This is a welcome decision.
I hope the judgement is read widely.
I have highlighted some extracts on (1) impact assessment , and (2) Risk Management.
Impact Assessment
171. In conclusion, it must be held that the Commission was obliged, pursuant to the precautionary principle, to carry out an impact assessment of the measures proposed. As is apparent from paragraphs 162 and 163 above, the formal and substantive requirements in that respect were moderate.
172 The Commission has acknowledged that there was no written record of such an assessment. Given that it must be assumed that there would have been a written record of any — even summary — assessment in the administrative file, and given that the Commission asserted that the College of Commissioners was sufficiently informed by the impact assessment conducted in connection with the restriction of the approval of neonicotinoids, it must be concluded from that absence of any written record that no impact assessment of the restrictions imposed by the contested measure was in fact carried out. (emphasis added)
173 The complaint alleging that there was no impact assessment and, accordingly, the plea alleging breach of the precautionary principle, must therefore be upheld.(emphasis added)
Risk Management
paragraphs 58-96 have an excellent discussion on the risk management.
I highlight three paragraphs, and added emphasis in bold in 3 points that deserve emphasis :
Para 65: The scientific risk assessment is not required to provide the institutions with conclusive scientific evidence of the reality of the risk and the seriousness of the potential adverse effects were that risk to become a reality. A situation in which the precautionary principle is applied by definition coincides with a situation in which there is scientific uncertainty. Furthermore, the adoption of a preventive measure, or, conversely, its withdrawal or relaxation, cannot be made subject to proof of the lack of any risk, in so far as such proof is generally impossible to give in scientific terms since zero risk does not exist in practice (judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T?31/07, not published, EU:T:2013:167, paragraph 140; see also, to that effect, judgment of 21 October 2003, Solvay Pharmaceuticals v Council, T?392/02, EU:T:2003:277, paragraph 130). However, a preventive measure cannot properly be based on a purely hypothetical approach to the risk, founded on mere conjecture which has not been scientifically verified
ii) The determination of the level of risk deemed unacceptable
71 The responsibility for determining the level of risk which is deemed unacceptable for society lies, provided that the applicable rules are observed, with the institutions responsible for the political choice of determining an appropriate level of protection for society. It is for those institutions to determine the critical probability threshold for adverse effects on public health, safety and the environment and for the degree of those potential effects which, in their judgment, is no longer acceptable for society and above which it is necessary, in the interests of protecting public health, safety and the environment, to take preventive measures in spite of the existing scientific uncertainty
2 In determining the level of risk deemed unacceptable for society, the institutions are bound by their obligation to ensure a high level of protection of public health, safety and the environment. That high level of protection does not necessarily have to be the highest that is technically possible, in order to be compatible with Article 114(3) TFEU (judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T?31/07, not published, EU:T:2013:167, paragraph 146; see also, to that effect, judgment of 14 July 1998, Safety Hi-Tech, C?284/95, EU:C:1998:352, paragraph 49). Moreover, those institutions may not take a purely hypothetical approach to risk and may not base their decisions on a ‘zero risk’ (judgments of 11 September 2002, Pfizer Animal Health v Council, T?13/99, EU:T:2002:209, paragraph 152, and of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T?31/07, not published, EU:T:2013:167, paragraph 146).
73 The level of risk deemed unacceptable for society will depend on the assessment made by the competent public authority of the particular circumstances of each individual case. In that regard, the authority may take account, inter alia, of the severity of the impact on public health, safety and the environment were the risk to occur, including the extent of possible adverse effects, the persistency or reversibility of those effects and the possibility of delayed effects as well as of the more or less concrete perception of the risk based on available scientific knowledge
Paragraph 96: Thus, it has already been held that a scientific risk assessment carried out as thoroughly as possible on the basis of scientific advice founded on the principles of excellence, transparency and independence is an important procedural guarantee whose purpose is to ensure the scientific objectivity of the measures adopted and preclude any arbitrary measure.