What is the difference between a US regulation and a EU directive or regulation | Enhesa (2024)

EHS Fundamentals

With regulations and directives at play, the US and the EU regulatory frameworks differ, affecting companies on both sides of the Atlantic.

The European Union and the United States have the largest trade and investment relationship in the world according to the European Commission and the US Trade Representative. With more and more businesses expanding their operations on both continents, companies are exposed to new sets of rules they are not always familiar with. With differences in legal structure and implementation, companies would be well served by understanding the basic structure of US and EU regulation. Let us give you some explanatory guidance.

US vs EU – different political structures with common ground

The US is a federal system comprised of 50 states, the District of Columbia and select US territories. By contrast, the EU is a unique economic and political union between 27 European countries. While the EU is not a federation, it has many features of a federal model as the power is divided between the central government (the 3 governing EU institutions) and Member States’ governments. Unlike the US, the EU lacks a formal constitution. However, the EU Treaties function in practice as a constitution since they define the allocation of powers between the different levels of governance and establish how legislation is adopted.

EU countries remain responsible for more policy areas than US states. For instance, the power to determine health policies lies with Member States (with some EU coordination), whereas it is the joint responsibility of the federal and state governments in the US. This makes sense, given that EU Member States are independent countries.

Why is this good to know? By contrast, environmental policy is shared between the central and national levels in the EU. In the US, the concept of cooperative federalism is a guiding principle. The federal government sets a baseline and the states are required to enact laws/regulations that are at least as stringent as the federal counterparts.

Laws/statutes/acts in the US, legal acts in the EU and regulations in both places – how do they differ?

Terms of art in both the US and the EU can be confusing. Here are some points of clarification.

US federal laws and regulations are similar in that they both seek to regulate behavior. Yet the procedure to adopt them is different: federal laws/statutes/acts are bills passed by Congress (through a legislative process), while federal regulations are made by executive departments and agencies through a rulemaking process.

Federal laws establish requirements or prohibitions that apply thought the US, whereas federal regulations clarify how an agency understands, implements and enforces existing laws. Regulatory violations can lead to the establishment of penalties.

EU regulations and directives are both legal acts adopted by the EU institutions following either the ordinary or special legislative procedure. Yet the way they are implemented is different.

EU regulations apply automatically and simultaneously in all Member States since they enter into force and do not require prior national transposition. Although they are immediately enforceable, Member States must still adopt certain administrative measures (for instance, to designate the authorities responsible for implementation or to set out penalties for non-compliance).

By contrast, directives need to be transposed into national law to become applicable, but Member States are free to choose the ways to reach the goals set out at EU level. In that regard, directives are more flexible than regulations since they are only binding as to the results to be achieved, while regulations are binding in their entirety.

Most of the EU environmental legislation has taken the form of directives, although regulations are gradually becoming more and more prevalent in those areas where a unified system is needed, such as chemicals and product safety.

US vs EU regulations: there’s a major difference in how far states can go vs member states

Despite their common name and legally binding character, EU and US regulations are actually quite different.

As explained above, EU regulations are adopted by legislative EU institutions (namely the European Parliament and the Council of the EU) through the legislative procedure, whereas US regulations are issued by the Executive by means of the rulemaking process.

In addition, US regulations follow the adoption of laws: they further develop how laws will be implemented, fill any existing gaps and interpret their provisions. On the contrary, EU regulations are more comprehensive pieces of legislation which can nevertheless be supplemented and detailed by Commission delegated and implementing acts, and further implemented by national administrative rules.

Regarding environmental policy, federal laws and regulations serve as a minimum standard but the US states can go beyond that baseline and adopt more stringent statutes and rules.

But in the EU, things are slightly different. Even if EU countries are often encouraged to adopt higher national environmental standards than those set by EU directives (as it is the case for air and water emission limits), such stricter rules cannot jeopardize the functioning of the Single Market. This means that they cannot lead to arbitrary restrictions or discriminations against the goods or services of other EU countries.

In addition, EU Member States are less likely to pass stricter requirements on those areas fully regulated by EU regulations (such as chemicals’ authorizations and waste shipments, to name a few) since these seek to set unified standards across the EU.

How does the difference between US and EU regulations impact your company?

Given the above, the following can be concluded:

  • EU regulations apply to all EU countries in a more uniform and consistent manner compared to federal regulations. Thus, if you operate in several EU Member States and there is an EU regulation, that regulation will be uniform in all member states.
  • If you operate in the US, you need to be aware of both the federal and state regulations applicable to your company and, sometimes, state regulations will be more stringent than federal regulations.
  • If you operate in several EU Member States and there is an EU directive that applies, you should be aware that Member States can reach the goal of the directive in different ways.

Therefore, understanding the difference between the various types of rules and legal acts is vital for companies as they continue operating internationally.

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What is the difference between a US regulation and a EU directive or regulation | Enhesa (2024)

FAQs

What is the difference between a US regulation and a EU directive or regulation | Enhesa? ›

EU regulations apply to all EU countries in a more uniform and consistent manner compared to federal regulations. Thus, if you operate in several EU Member States and there is an EU regulation, that regulation will be uniform in all member states.

What is the difference between EU directive and regulation? ›

unlike a regulation, which is directly applicable in Member States after its entry into force, a directive is not directly applicable in Member States, it must first be transposed into national law before it is applicable in each Member State; unlike a decision, the directive has general application.

What is the difference between US and EU data privacy laws? ›

The GDPR is one of the most comprehensive data protection laws in the world and provides an overarching framework for the processing of personal data in the EU. By contrast, U.S. state laws are more targeted in their scope and contain a narrower set of obligations.

What is the EU definition of regulation? ›

Regulations are legal acts defined by Article 288 of the Treaty on the Functioning of the European Union (TFEU). They have general application, are binding in their entirety and are directly applicable in all European Union (EU) Member States.

What are key differences between EU law and international law? ›

Although EU law may be regarded as a specific form of international law, the main body of EU law has some particular features which usually do not appear in international law: in particular, citizens can invoke rights guaranteed by EU law before courts in the EU Member States, whereas international law usually needs to ...

What is directive and regulation? ›

Directives and Regulations are the main forms of EU law. Directives. EU Directives lay down certain end results that must be achieved in every Member State. National authorities have to adapt their laws to meet these goals, but are free to decide how to do so.

What is an example of an EU regulation? ›

For example, when the EU decided to take action to better protect human health and the environment against the risks associated with chemical substances, it adopted Regulation (EC) No 1907/2006 (known as the REACH regulation – see summary) on this issue. Regulations form part of the EU's secondary law.

What is the difference between US and EU fair information practices? ›

In the EU, the rules regarding individual consent for data collection, use, and disclosures are much stricter, and much more affirmative consent is required. In the US, privacy legislation exists in certain industries but each industry's legislation is different, and many repositories of data aren't regulated.

How does the European Union approach data protection differently than the United States? ›

In the EU the approach is called "omnibus" in that there is one single privacy law, which by its nature has to adopt general principles, so cannot be as specific, even though it covers a larger scope of all data of anyone (as opposed to say CCPA that looks mainly at Californian consumers).

What is the US equivalent to EU GDPR? ›

The CCPA (California Consumer Privacy Act) is the US equivalent of GDPR. This comprehensive data privacy act gives Californian residents greater transparency and control over how businesses collect and use their personal information. What are the main principles of GDPR?

How is an EU regulation made? ›

The European Commission submits a proposal to the Council and the European Parliament. The Council and the Parliament adopt a legislative proposal either at the first reading or at the second reading. If the two institutions do not reach an agreement after the second reading a conciliation committee is convened.

What is the definition of a regulation? ›

1. a law, rule, or other order prescribed by authority, esp. to regulate conduct. 2. the act of regulating or the state of being regulated.

What is the EU better regulation policy? ›

'Better regulation' is a set of practices to ensure that EU regulations are evidence-based, made in a transparent and inclusive way, and are as simple and targeted as possible to reduce unnecessary burdens.

Are EU directives legally binding? ›

A directive shall be binding, as to the result to be achieved, upon each Member State to which it is addressed, but shall leave to the national authorities the choice of form and methods. A decision shall be binding in its entirety upon those to whom it is addressed.

What are the 4 principles of the EU? ›

The common principles and values that underlie life in the EU: freedom, democracy, equality and the rule of law, promoting peace and stability.

Does EU law override national law? ›

The principle of the primacy (also referred to as 'precedence' or 'supremacy') of European Union (EU) law is based on the idea that where a conflict arises between an aspect of EU law and an aspect of law in an EU Member State (national law), EU law will prevail.

What is the EU investment firm directive and regulation? ›

The new EU Investment Firms Regulation (IFR) and Investment Firms Directive (IFD) is a new, bespoke EU prudential regime for MiFID investment firms. The IFD/IFR began to apply to firms from 26 June 2021. The IFR/IFD introduces own funds, liquidity assets, remuneration, governance, and reporting requirements.

What is the key difference between the EU directive and the CAN SPAM Act? ›

The biggest difference between the ePrivacy Directive and the CAN-SPAM Act is that the former specifies that people have to opt in to receiving emails, whereas the latter is concerned only with the ability to opt out.

What is the EU rights directive? ›

About the directive

It aligns and harmonises national consumer rules, for example on the information consumers need to be given before they purchase goods, services or digital content, and on their right to cancel online purchases, wherever they shop in the EU.

What is the difference between GDPR and EU Data Protection Directive? ›

The GDPR supersedes the Data Protection Directive and will fully phase out the DPD and become national law for all EU Member States by May 25, 2018. The GDPR builds on the key tenets of the DPD with more specific data protection requirements, a global scope, and stiffer enforcement as well as non-compliance penalties.

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