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New derogating national provisionsThe possibility of introducing new national provisions once a harmonising EU measure has been adopted is now regulated in paragraph 5 of Article 114, according to which if, after the adoption of a harmonisation measure by the European Parliament and the Council, by the Council or by the Commission, a Member State deems it necessary to introduce national provisions based on new scientific evidence relating to the protection of the environment or the working environment on grounds of a problem specific to that Member State arising after the adoption of the harmonisation measure, it shall notify the Commission of the envisaged provisions as well as the grounds for introducing them. Compared to the one on the maintaining of national provisions, this paragraph introduces a number of additional conditions, some of which are very demanding indeed, that have to be met if the national provisions are to be approved. According to the Court of Justice this difference is motivated by the fact that new national legislation is more likely to jeopardise harmonisation since the EU institutions could not, by definition, have taken account of it when drawing up the harmonisation measure.[1] In the case of new national provisions the ‘mandatory requirements’ of Article 36 TFEU are not relevant and only grounds relating to protection of the environment or the working environment are accepted. This gives rise to the interesting question of whether ‘the protection of health and life of humans, animals or plants’, which is listed in that Article, cannot justify new national provisions? It cannot be disregarded that a reference to Article 36 has been included in relation to the maintenance of national provisions but not when it comes to the introduction of new ones. However, that environmental protection should have been granted a more privileged status in this regard than protection of human life and health seems unlikely, since it is evident that the latter is the more weighty concern in other situations.[2] [3] [4] It should also be recalled that ‘protecting human health’ is in fact one of the objectives to be pursued by the EU’s environmental policy and thus falls, at least as long as the threats to human health are related to the conditions of the physical environment in which humans live, within the concept of protection of the environment. A reasonable interpretation of the absence of a reference to Article 36 in Article 114(5) is thus that the other grounds listed in Article 36, including national treasures possessing artistic, historic, or archaeological value and the protection of industrial and commercial property, cannot justify new national provisions, whereas the protection of human life and health is anyway not dependent on a reference to Article 36. It should also be noted that ‘public health issues’, such as the health effects of tobacco and alcohol, may not be subject to harmonising measures and should thus not give rise to any need for national derogations (Art 168(5)). As regards the problem to be addressed by the new national provisions, it must both be ‘specific’ to the Member State concerned and have arisen after the adoption of the harmonisation measure. Clearly, a problem that is generally occurring throughout the Union can hardly be specific to a Member State. However, ‘specific’ is not to be equated with the more restrictive notion ‘unique’. The General Court has indicated, and the Court ofJustice confirmed, that the existence of ‘unusual’ ecosystems in a Member State could suffice to render a problem specific to that State.35 The General Court has also talked of ‘local particularities’ as being able to constitute a specific problem^6 It has moreover found that a remedy at the national level, rather than an amendment to the relevant EU legislation, could, at least initially, be appropriate ‘either because of the purely local nature of the phenomenon, or because of the particular characteristics which it exhibits locally and which are incompatible with the delays inherent in the negotiation and entry into force of new harmonised rules’. It is thus necessary to envisage the requirement of national specificity of a problem ‘from the angle of the aptness or inaptness of the harmonisation of the applicable [EU] rules to confront adequately the difficulties encountered locally’.[5] [6] [7] Although demanding, the requirement for the problem to be specific to the Member State concerned should thus not be as prohibitive as it may first appear. The problem must also have arisen after the adoption of the harmonisation measure. The logic underpinning this condition is that problems that were known at the time of the adoption of the harmonisation measure have already been considered by the EU legislator, or could at least have been introduced into the discussion by the Member State concerned. If, however, a problem did in fact exist but was not known to either the relevant EU institutions or to the Member State in question, that should not preclude its consideration once it becomes known.38 Reasonably, the same logic should apply if the extent of the problem has grown dramatically since the adoption of the harmonisation measure, provided that such aggravation of the problem should not reasonably have been foreseen at that time. As for the need to base the national provisions on new scientific evidence, it is reasonable that new conclusions drawn on the basis of pre-existing data count as new scientific evidence^9 Data in itself, without the application of an appropriate scientific method, cannot constitute the basis of sound decision-making. And to preclude the use of scientific evidence on the ground that the data on which it is based may previously have been interpreted in a different way would be contrary to the very idea of science as a generator of increasingly better understanding of the world around us. The requirement for ‘evidence’ must also be interpreted in the light of the precautionary principle. It can thus not be a matter of requiring that the evidence be completely uncontested.[8] [9] In fact, the Court of Justice has even held that it may suffice that a Member State makes an assessment of the risk to public health which is different from that made by the EU legislature in the harmonisation measure, even if such assessment is not based on new or different scientific evidence^1 The determination of whether the conditions of Article 114(5) are satisfied may necessitate complex technical evaluations, in which case the Commission enjoys a wide discretion. It must, however, examine carefully and impartially all the relevant elements of the individual case and give an adequate statement of the reasons for its decision which may be subject to review by the Court. The Commission must in particular take account of all available new scientific and technical data.[10] [11]2
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