EHS Fundamentals

What’s the difference between EU directive vs regulation

EHS professionals in the EU should understand the important distinction between an EU Directive and an EU Regulation.

Knowing the difference between an EU Directive and an EU Regulation is an important distinction every EHS professional working and/or operating in the region should know. Legal terminology is designed to confuse. If it was simple, there would be no need for lawyers! For example, as we discussed in another recent blog post, the words for “permit”, “authorization”, “license” and “registration” can cause a great deal of confusion, as they can mean the same, or slightly different things.

Similarly, explaining to someone the difference between “laws”, “standards”, “rules”, “legislation” and “regulations” can also be confusing. Even in English the meanings and context of these words can be interchangeable. All laws are legislation, but all laws are not regulations. Standards are not typically legislation, but in some countries, they are. Acts are legislation, and in one sense are regulations, but in another sense, they are not. You get the picture…

European Union law is no different. At the EU level, there are “treaties”; “regulations”; “directives”; “decisions”; “recommendations”; “opinions”; and “communications” …

For the purposes of environmental and health & safety management the most important of these legal instruments are regulations and directives. But what is the difference?

What is a EU Directive?

  • Applicable to all Member States
  • Sets aims, requirements and concrete results that must be achieved in every Member State
  • Sets a process for it to be implemented by Member States
  • National authorities must create or adapt their legislation to meet these aims by the date specified in each given Directive, but each Member State is free to decide how they implement the Directive.

What is a EU Regulation?

  • Immediately applicable and enforceable by law in all Member States
  • As good practice, Member States issue national legislation that defines the competent national authorities, inspection and sanctions on the subject matter

What does this mean for an EHS regulatory compliance program?

Most importantly, it is very important to maintain awareness of the wider context and implications of the distinction. Essentially a regulation applies across the board, directly, with no need for member states to do anything in terms of lawmaking (much beyond assign responsible national authorities).

With regards to EHS laws, EU Regulations are used when it comes to environmental issues that have cross-border and market implications, such as Chemicals and Waste management, and which therefore require a harmonized approach.

Two of the most prominent EU Regulations are the “REACH” and “CLP” Regulations, which regulate different aspects of chemicals.

Directives give EU member states a certain amount of flexibility

As per the aforementioned definitions, Directives give EU member states a certain amount of flexibility on how to implement their requirements. This essentially means there can be at least 28 different implementations of an EU Directive across the European Union. Some countries will simply adopt the provisions of a Directive verbatim – others may go further and beyond the bare bones requirements of the Directive – often to align with historical and cultural practices, but also to align with technology and best practice.

Let’s zoom in, and look at a few directives

There are many examples of word-for-word transposition of EU Directives in Slovakia, mainly those concerning product safety. A noteworthy example is Directive 2006/42/EC on machinery. The transposing Regulation No. 436/2008 Coll. on technical requirements and conformity assessment of machinery refers directly to the requirements of Annex I to the Directive. Machinery placed on the market or put into service must comply with these requirements.

It is also interesting to compare the transposition of the WEEE Directive 2012/19/EU in Slovakia and in the Czech Republic. While the main requirements of the Directive in terms of extended producer responsibility and take-back requirements are transposed in the same way in both countries, there are discrepancies in the practical application of these requirements. These include different registration and reporting procedures, and fees for take-back.

An example of national legislation going beyond the requirements of EU legislation is the Czech Act No. 25/2008 Coll. on the integrated pollutant register. The Act goes beyond obligations created by Regulation EC/166/2006 (E-PRTR Regulation); in addition to obligations listed in the Regulation, companies must also report pollutants if they exceed the levels for the release or off-site transfer of waste containing polluting substances, which are specified in the Annex.

In Italy, an example of a different level of implementation of an EU Directive is also found regarding Waste Framework Directive (2008/98/EC).

Part IV of the Environmental Code, which transposes this Directive, often copy-pastes the Directive’s articles word-for-word: for instance, the definition of waste (“any substance or object which the holder discards or intends or is required to discard”), the waste hierarchy or the conditions to classify by-products are literally translated from the provisions of the Directive.

Conversely, the same implementing legislation sets a more detailed waste classification framework, going beyond the requirements of the Directive: the obligation for the Member State is to establish at least the category of hazardous and non-hazardous waste, whereas the Italian law sets a further classification according to the origin of waste (special waste, mainly from industrial activities and urban waste, partly from household waste).

Moreover, an extensive interpretation of the general principle of the extended producer responsibility, enclosed in the Directive, is also found both in the implementing legislation and the case law. All operators of the waste stream are in principle liable unless they demonstrate to have complied with strict rules regarding records and documents. The case law applies this principle in a strict way.

In fact, implementations can even vary within individual Member States. One example of this is Directive 2010/75/EU on industrial emissions (the IED Directive) which is aimed at reducing emission levels and requires the use of a permitting system to achieve this. The way this permitting system operates is down to each member state.

However, in the UK the IED Directive is implemented in different ways. In England and Wales, it is implemented under the Environmental Permitting Regulations 2016. Environmental Permits are issued for all areas concerning the environment where industry must comply with restrictions. This includes restrictions relating to waste, air, water and radioactive substances. This means that one piece of regulation implements the requirements of various directives in addition to the IED Directive. However, in Scotland, which is responsible for its own environmental regulation, there is no such integrated approach (although this may change in the future). The IED Directive in Scotland is implemented through the Pollution Prevention and Control (Scotland) Regulations 2012. These Regulations require a Pollution, Prevention and Control Permit to be obtained for the purposes of the IED Directive. However, unlike in England and Wales these Regulations do not cover permits concerning waste, water and radioactive substances. These areas are dealt with each under a separate set of Regulations and require individual permits. This demonstrates the different approaches that can be taken when implementing EU Directives.

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