European Union - 3-Legal RegimeEuropean Union - Legal Regime
The European Commission, which has the sole authority to propose EU-wide laws, publishes an Annual Work Program setting forth its intent to legislate on particular matters in the coming year. This report can be found at: Annual Work Program
Inclusion of planned regulation in this list is usually followed by the issuance of a “roadmap” that generally describes possible options and spells out the process for developing a proposal. Such steps include a public consultation intended to inform the Commission’s development of a formal legislative proposal, and a supporting impact assessment. In turn, member state officials examine and amend these proposals in Council, as does the European Parliament; Council and Parliament positions are publicly available. Where those positions differ, the three institutions – Commission, Council, and Parliament –agree on the final text of legislation through closed-door negotiations known as “trilogues.” All adopted measures are published in all EU languages in the EU's Official Journal.
In many instances, the European Commission has broad discretion to promulgate detailed rules with less or no review by other bodies, and with varied procedures depending on context. For example, EU primary regulations often include authority for the Commission to elaborate additional or more detailed aspects in the form of either “delegated” or “implementing” acts. The Commission’s proposals are subject either to an override by the Council or Parliament, or to approval by Member States.
In 2016, as part of its “Better Regulation” agenda, the Commission began, in at least some cases, to publish the draft texts of these proposed delegated or implementing acts for a four-week public review, which to some extent, coincides with requirements to notify proposed measures to the WTO. However, many contexts, such as standard setting or chemicals, include upstream procedures to evaluate product hazards that are dominated by member state expert committees and “independent” agencies such as ECHA (European Chemicals Agency) and EFSA (European Food Safety Authority) that are not subject to the new Better Regulation frameworks. Furthermore, many sectors subject to more specific regulations set forth in the secondary legislation described above - delegated and implementing acts - are in effect governed via meetings and processes involving expert groups of member state representatives and designated European companies.
Despite new opportunities for public “feedback” and debate in the early phases of rulemaking as part of the “Better Regulation” program, U.S. companies and other stakeholders continue to struggle in their efforts to obtain detailed draft text and key information in a timely manner concerning the Commission’s legislative proposals. Without this information, stakeholders are limited in their ability to fully understand and determine potential compliance or operational costs to trade and investment in the EU. As a result, there is no opportunity for the public to comment on the actual text of proposed legislation until after the Commission has sent its formal proposal forward for consideration by its “legislative” branches, the Council and Parliament. In a manner that is inconsistent with good regulatory practices observed by many OECD member states, the actual draft is not made available during the key phase when the Commission could still make technical amendments. Rather, Commission directorates issue more general consultation documents, usually accompanied by questionnaires, soliciting public views before a Commission proposal is particularly developed. As it develops the details of its proposal, the Commission may call invitation-only meetings with experts as a means of obtaining specific information; however, these meetings are not necessarily designed to include all potential global stakeholders, and may be restricted to only European stakeholders. Consequently, the impact assessment developed by the Commission during this period is only published with its final proposal, rather than being made available for public review and comment at an earlier stage.
Another example of a systemic lack of transparency and access for U.S. exporters is standards development. In order to participate in EU standards making, a company must have a physical presence in the European Union. To the extent EU regulations allow private conformity assessment bodies (CABs) to perform conformity assessment activities for products, they do not recognize U.S. CABs conduct of conformity assessments on U.S. soil, except under the U.S.-EU Telecom MRA, where qualified U.S organizations can obtain Notified Body status under the Radio Equipment Directive and the Electromagnetic Compatibility (EMC) Directive.
For specific information on member states' openness to foreign investment, please consult the Commerce Department's Country Commercial Guides of the 28 EU member states found at the following website: EU Member States' Country Commercial Guides
European Union 28 Economic Development and Investment Law