European agencies and the implementation of global standards in the EU

This presentation analyzes the role of EU agencies in the implementation of global standards, focusing on the regulatory areas of pharmaceuticals, foods, chemicals. In these fields, EMA, EFSA and ECHA participate in the setting of standards on the global level (e.g. in the ICH, the Codex and the OECD) and are an important gateway for global standards into the EU legal framework, often due to the adoption of administrative soft law. This presentation will examine the role of EU agencies in global standard-setting in-between the global and EU level. It will compare their role in the setting of pharmaceutical, chemical and food standards as well as the role these bodies play in the implementation of global standards on the EU level, revealing sector specific differences in the practices of the agencies. Finally, it will question the legitimacy of EU agencies as key actor in the implementation of global standards, by examining its compliance with basics principles of good administration.

Global standards and EU environmental law

The purpose of this presentation is to map, examine, and analyze the role of the EU in participating in the setting of international environmental standards, as well as the implementation of these standards within the supranational EU legal order. In a first section, the presentation will define and delineate what are considered to be “international environmental standards” for the purpose of this contribution. Once the relevant set of relevant international environmental standards has been determined in a first substantive section of the chapter, attention turns towards two key aspects: i) the EU’s participation in global environmental standard-setting bodies and organizations; ii) the implementation of global environmental standards within the EU, through instruments such as Directives and Regulations; and iii) the role of stakeholder participation.

Engaging with Global Standards in European Union Agriculture: an Exploration of the Governance Field

In an era when consumers/citizens are concerned how agriculture produces food and fibre, public and private actors have sought to address such concerns through the introduction of standardisation schemes which have acquired an international dimension. This presentation will explore the extent of EU engagement with global agricultural standards in two areas, namely biofuels and animal welfare. Themes to be developed include: (i) difficulties in categorising whether the regulatory interface is public, private or ‘hybrid’, with potential legal consequences; (ii) conformity with conventional principles of governance; and (iii) the degree to which the measures are effective to inform consumer/citizen choice. Further, there will be the opportunity to contrast the position between, on the one hand, a relatively mature system as currently in place for biofuels and, on the other hand, EU engagement with animal welfare standardisation where work remains more in progress.

Standards on the move: Global standardisation and EU transport policy

The presentation maps the international standards developed in the specific fields of air, road, rail and maritime transport, highlighting the plurality of levels and actors involved in the process. Particular attention is devoted to the Standards and Recommended Practices (SARPs) developed by ICAO and to the standards elaborated by UNECE on CO2 emissions for road vehicles. It will focus specifically on the transparency of decision-making in the global standard-setting process and the participatory possibilities of societal stakeholders, as well as on the legal mechanisms according to which these standards are incorporated in different acts of the EU legal system and the implications of this incorporation for principles such as legal certainty and legitimate expectations. The analysis will be concluded with a reflection on the challenges to EU administrative law, highlighting the gaps and issues with respect to the principles of the rule of law and effective judicial protection.

International Standards in the EU’s Digital Trade Chapters & Negotiations: On Internationalisation

The EU is a long-standing internationalist in the global legal order. It advocates regulatory cooperation predicated upon international standards and seeks regulatory cooperation also in the absence of global consensus of standards. One specific area of interest is the EU’s practices of internationalisation in digital trade and its links to data adequacy decisions. The EU commits to very high standards of privacy protection in its model horizontal texts. Here the EU has sought to generate best practice as to digital trade with the world’s leading developed economies. But what of internationalisation here? Much global administrative law considers the application of international standards. Yet what about the challenges of the absence thereof for regulators? National authorities increasingly send detailed practical questions to the CJEU on international data transfer standards. The paper considers the framing of internationalisation in EU-Japan, EU-Canada, EU-UK digital trade chapters.