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Prima facie, only the outcome of the internal review – that is any action or inaction taken within these proceedings – can be reviewed by the Court, as the standing to challenge the original decision is governed by Article 263 TFEU and Regulation 1367/2006 cannot possibly change the primary law. [...]internal review was introduced as an alternative to judicial review, the availability of which was meant to remain limited. If the request for internal review is not to become a fast track to annulment action, in contravention of the established standing rules, there should be a fine line drawn to establish some differences between the review of the conclusion of internal review of a certain administrative act and of an annulment action against the same act. [...]the Court stated that when reviewing internal review, courts should consider only the following allegations: lack of powers, infringement of essential procedural requirements, infringement of the treaties or of any legal rule relating to their application, or misuse of powers (paragraph 56). The Court started by pointing out that when the Union institutions must make a complex judgment, their discretion is wide, while judicial review is limited to verifying that the measure is not vitiated by manifest error, misuse of power or that the bounds of discretion are clearly exceeded. [...]far, this triad is very well established in its case law, most notably in Pfizer. 16 However, the Court went on to add that this does not prevent the courts from verifying whether the evidence relied on is factually accurate, reliable and consistent, and whether that evidence contains all the information that must be taken into account to assess a complex situation and whether it can substantiate the conclusions drawn from it (paragraph 79). On 17 July 2017 the Council unanimously accepted the findings of the Committee (disregarding the Commission’s position on the contrary). [...]the pressure for broadening the standing is mounting, and the CJEU–which has the final word on interpretation of the treaties–will struggle to square its antiquated doctrine with the international law.

According to this triangle, three different types of institutions are involved into the creation of standards: non-Governmental institutions, states, and firms. 52 The smaller the influence of states, the more the standard is considered “private”. [...]an approach may be reasonable if one takes into account the classical underlying rationale of the fundamental freedoms. Since the judgment in Cassis de Dijon, regulations “behind the border” are, as a default option, subject to a competition of legal orders of the Member States, orchestrated by EU primary law. 60 If the EU wants to harmonise in these areas, it needs to do so via secondary legislation. According to the seminal judgment in Francovich ,63 state liability can only be established under three conditions: “The first of those conditions is that the result prescribed by the directive should entail the grant of rights to individuals. [...]the third condition is the existence of a causal link between the breach of the State’s obligation and the loss and damage suffered by the injured parties.”

Joined Cases C-78/16 and C-79/16, Giovanni Pesce (et al) v Presidenza del Consiglio dei Ministri, [2016] EU:C:2016:428. In Xylella, the Court of Justice of the European Union (CJEU) was called upon to assess how far policymakers can go in conditions of scientific uncertainty, and whether EFSA opinions can be indirectly subject to judicial review, despite not being legally binding. In particular, the Xylella case highlights the relevance of EFSA’s scientific authority over the Commission: since EFSA opinions are not directly reviewable by the CJEU – as they constitute an intermediate stage of a more complex administrative procedure – the political and legal liabilities relating to EFSA assessments are entirely shifted onto the Commission, whose discretion is reviewable by the EU judiciary. In this regard, the Xylella case confirms how difficult the judicial review of precautionary measures can be. It shows once again that a full assessment of these measures is impossible, as scientific uncertainty restricts the grounds for judicial review to the manifest appropriateness of the contested measures and the availability of less onerous and equally effective measures.

[...]the principle of proportionality was raised in relation to the period needed to plan and order new packaging to meet the timeline of the Directive. Any challenge to the suggestion that flavourings were “traditional” (ie referring to mentholated tobacco product) and that such perception of the product should therefore lead to relaxed rules regarding it had already been rejected in Poland v Parliament & Council.6 It was determined by the Court that prohibition of flavoured products was appropriate within the scope of the internal market for tobacco and related products, and ensured the “high level of protection of human health, especially for young people”.7 The importance of the protection of the health of citizens from tobacco-related harm was re-emphasised. Information regulation had previously been judged in R v Secretary of State for Health, ex p British American Tobacco (Investments) Ltd and Imperial Tobacco Ltd 11 to effectively discourage the harmful effects of tobacco products,12 and in Poland v Parliament and Council and Philip Morris Brands and Others the Court found that there was a balance struck between economic consequences and protections of human health.13 The World Health Organisation (WHO) has also noted clear links between tobacco usage and declining health.14 The WHO even categorised tobacco usage as a specific hindrance to meeting sustainable health targets globally on an annual basis.15 Therefore, the tobacco manufacturers do not now challenge the question of the health effects of tobacco products, but have repeatedly focused on perceived flaws in the Directive itself. The CJEU must clarify vagueness in EU legislation in the event of uncertainty on the part of the national court, but made clear in Srl CILFIT v Ministry of Health that national courts are not obliged to seek such clarification if the “community provision in question has already been interpreted by the Court of Justice or that the correct application of community law is so obvious as to leave no scope for any reasonable doubt”.21 This is important because cases are often brought by collections of tobacco manufactures acting with common purpose.

II Alleged breach of the precautionary principle The precautionary principle is intended to ensure a high level of environmental protection in all the EU’s spheres of activity, by allowing EU institutions to take protective measures without having to wait until the reality and extent of those risks become fully apparent or until the adverse effects materialise. 6 The principle is enshrined in the Treaty on the Functioning of the EU and is often included or reflected in EU secondary legislation. 7 The parent Regulation of the contested measure explicitly states that its provisions are “underpinned by the precautionary principle in order to ensure that active substances or products placed on the market do not adversely affect human or animal health or the environment”. In line with previous cases, the Court explained that: within the process leading to the adoption by an institution of appropriate measures to prevent specific potential risks to public health, safety and the environment by reason of the precautionary principle, three successive stages can be identified: first, identification of the potentially adverse effects arising from a phenomenon; second, assessment of the risks to public health, safety and the environment which are related to that phenomenon; and, third, when the potential risks identified exceed the threshold of what is acceptable for society, risk management by the adoption of appropriate protective measures. 9 The risk assessment stage is subject to certain checks and balances. 10 For example, the assessment is to be entrusted by the institutions to scientific experts, based on the best scientific data available and undertaken in an independent, objective and transparent manner. 11 Although the assessment is not required to provide the institutions with conclusive evidence, a preventive measure “cannot properly be based on a purely hypothetical approach to risk, founded on mere conjecture which has not been scientifically verified”. 35 At the time, however, the authoritative statement on procedure was contained in the Communication, which does not prescribe a particular form of evaluation. Because of this, the Court held that “it is not at all apparent that the authority concerned is obliged to initiate a specific assessment procedure culminating, for example, in a formal, written assessment report. [...]there were no obligations to include a literature review in the EFSA procedure.

In the aftermath of the Technical Board of Appeal's decision T 1063/18 of 5 December 2018 (\"the Pepper case\"), the President of the EPO has referred, in G 3/19, two questions to the Enlarged Board of Appeal pursuant to Article 112(1)(b) of the European Patent Convention concerning the patentability of products obtained from essentially biological processes under Article 53(b) EPC. The Technical Board of Appeals in T 1063/18 upheld that the new Rule 28(2) of the Implementing Regulations to the European Patent Convention conflicts with Article 53(b) EPC, as it has been interpreted by the Enlarged Board of Appeal in G 2/12 and G 2/13 (the \"Tomato II\" and \"Broccoli II\" cases), namely that \"the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC does not have a negative effect on the allowability of a product claim directed to plants or plants material such as fruit\". Moreover, the TBA concluded that Article 58(b) EPC should prevail over Rule 28(2) EPC-IR. Since this ruling challenges the Administrative Council's amendment to Rule 28 EPC-IR, the President deemed it necessary to refer the conflict to the EBA in order to \"restore legal certainty\".

[...]this exception to immediate public disclosure as foreseen by Regulation 1049/2001 does not apply. 1 I Facts On 13 July 2017, the Court of Justice of the EU (CJEU) delivered its judgment in an access to documents case brought by a private party (the German glass producer Saint-Gobain) against an EU institution (the Commission) concerning a document of a national government (the Federal Republic of Germany). [...]of this interpretation, documents drawn up in the course of an administrative procedure may also come under the Article 4(3) exception. Significantly, the Court’s reference to the Aarhus rules comes in the context of the “space to think” clause contained in Article 4(3) of Regulation 1049/2001, and not in the context of a potential wider duty emerging out of Article 6(1) of Regulation 1367/2006. [...]the judgment does not clarify the relationship between the dual obligations of strict interpretation stemming from both regulations. [...]it remains very difficult to establish a consistent pattern or doctrine related to (non-) disclosure of administrative documents.

[...]whereas commercial arbitration “originate[s] in the freely expressed wishes of the parties”, ISDS results from a treaty by which the Member States agree to remove a matter from the jurisdiction of their own courts. 15 Secondly, the foreign investor is entitled to bring its claim before the arbitral tribunal and is thus not required to exhaust any judicial options under internal law. [...]the tribunal instituted under the Netherlands-Slovakia BIT is not part of the “judicial system” of the contracting parties. 40 The criterion of “establishment by law” prevails over other criteria such as permanent and compulsory jurisdiction, independence, application of rules of law, and adversarial procedure. 41 It is beyond doubt that the arbitral tribunal originated from a treaty and not an arbitration agreement contained in a contract. [...]the dispute resolution mechanisms provided for under BITs concluded between Member States and third countries will also prove to violate Article 267 and 344 TFEU where the arbitral jurisdiction is liable to concern either the application or the interpretation of EU law. [...]with respect to UNCITRAL arbitrations in which the seat of arbitration is outside of the EU Member States, the domestic court could review whether the award breaches a public policy interest.

[...]the exceptions to that principle, reflecting the need to take into account competing claims, such as commercial interests and intellectual property, should be interpreted strictly. 16 The goals pursued by the “Access regulation” are not only shared, but also further qualified by Regulation 1367/2006. According to the Court of Justice’s case law, 19 the emissions covered by the “Aarhus regulation” are to be understood as those “affecting or likely to affect elements of the environment, in particular air, water and soil”. According to it, transparency and openness serve multiple functions in relation to environmental matters; more specifically, they relate both to the correctness (ensuring that decisions are justified, ascertaining whether the emissions were correctly assessed, giving the public the opportunity to check) and to the legitimacy of the decisions taken by the institutions. 38 What is remarkable is the fact that such considerations appear in relation to highly technical matters. According to the Court, on the one hand, the Aarhus Convention has primacy over EU secondary law, which must be interpreted in accordance with it and, on the other hand, Art 4(2)(d) of Directive 2003/4 and Art 6(1) of Regulation 1367 are intended to implement the same article of the Aarhus convention, and should therefore be interpreted consistently. 26 Anthony C Tweedale v European Food Safety Authority, supra, note 13, para 99; Heidi Hautala and Others v European Food Safety Authority, supra, note 14 para 106, quoting Bayer CropScience and Stichting De Bijenstichting, supra, note 19, para 86.

Identical issues arise in the context of Directive 2002/53 as were addressed by the Court in the first question, ie whether varieties obtained with new mutagenesis techniques qualify as GMOs and, if so, whether these are exempted by virtue of Art 4(4) analogous with Art 3 and Annex IB of the Deliberate Release Directive. Because the latter provides the framework for the former, it is only logical that the Court should answer the questions identically: “… genetically modified varieties obtained by means of techniques/methods of mutagenesis such as those at issue in the main proceedings, with the exception of varieties obtained by means of techniques/methods of mutagenesis which have conventionally been used in a number of applications and have a long safety record, come within the scope of Article 4(4) of Directive 2002/53 and the obligations with regard to the protection of health and the environment laid down in that provision for the purpose of acceptance for inclusion of the varieties in the common catalogue”. [...]to the extent to which the EU legislature has not regulated those organisms, Member States have the option of defining their legal regime by subjecting them, in compliance with EU law, in particular the rules on the free movement of goods set out in Arts 34–36 TFEU, to the obligations laid down by Directive 2001/18 or to other obligations. 47 To rule otherwise, ie that Member States have lost all powers to regulate mutagenesis, would imply that the Union legislator at the time of adopting the Deliberate Release Directive considered all techniques prima facie safe. [...]within the limits of primary EU law, in particular Arts 34 and 36 TFEU, and Art 22 of the Directive, national measures that serve no obvious purpose are allowed to compromise the internal market, and environmental protection is allowed to suffer because potentially risky techniques are likely to remain unregulated. 48 It is hard to see how to square this outcome with the general context and purpose of the Deliberate Release Directive, which the Court claimed guided it in performing its judicial surgery on the Directive. [...]if – as we have suggested – the precautionary principle should also be understood as limiting the Union legislator’s discretion not to act (to control uncertain risk), precaution also serves to eat into the Court’s conventional reserve to annul general legislative acts (option (c)), above all in cases when these fail to take account of undisputed new uncertain risks.