Doing Business the EU way

By Marlies Huijbers

EU compliance: What are your next steps?

The European Union (EU) is developing more and more environmental legislation, thereby enlarging its influence in this field. Does this just represent an increasing regulatory burden; or could this also create business opportunities? Before going further let’s review the EU’s key legal instruments.

Key legal instruments

The EU has four main legislative instruments:

• Regulations. A regulation is generally binding and directly applicable in all Member States.
• Directives. A Directive is binding, but the Member States are free to choose the form and methods to obtain the result.
• Decisions. A decision is binding only upon those to whom it is addressed.
• Recommendations and opinions. These have no binding force.

Examples of all these EU legislative instruments are:

Regulation: CLP Regulation EC/1272/2008. This Regulation ensures that the Globally Harmonised System of Classification and Labelling of Chemicals of the United Nations is used for the classification, labelling and packing of substances and mixtures placed on the EU market and used within the EU.

Directive: Directive 2010/75/EU  on industrial emissions. This Directive specifies what conditions permits for heavy industry as listed in Annex I (such as a production of pharmaceuticals, plant protection products and biocides) must contain. For example, permitting authorities have to include the best available techniques in permits issued under this Directive.

Decision: Commission Implementing Decision EU/2015/2337  determining quantitative limits and allocating quotas for controlled ozone depleting substances for 2016. The Decision indicates which companies are allowed to use ozone depleting substances and in which quantities.

Opinion: Opinion on the clean air policy package for Europe of the Committee of the Regions. The Committee recommended that the European Commission ensured that the review of Directive 2001/81/EC on National Emission Ceilings was ambitious enough to reduce background concentrations.

Latest developments, instrument use

As the instruments have different objectives they affect businesses in different ways. The choice of an instrument can increase a burden or create business opportunities making EU trends and developments in the choice of instrument important.

As a legal advisor in the EHS legislative field for over 10 years, I have had a chance to study these changes, over time.

I would first note the EU is trending in the direction of using fewer Directives and Decisions, but more Regulations. So, Directive 67/548/EEC on the CLP of dangerous substances and Directive 1999/45/EC on the CLP of dangerous preparations were replaced by the CLP Regulation. Decision 2007/589/EC on the monitoring and reporting of greenhouse gas emissions and verification of the emissions’ information was replaced by two Regulations.

Another development is that the EU is now more frequently evaluating its environmental legislation by carrying out ‘fitness checks’, asking whether legislation has been effective (objectives met), efficient (involved costs reasonable) and if EU action is still necessary. For example, in May 2016, the EU launched a consultation on the regulatory fitness of chemicals legislation (excluding REACH). This concerned approximately 20 Regulations and 35 Directives covering hazard identification and classification, and risk management measures ranging from worker safety to environmental protection. The aim of the consultation was to obtain stakeholder views on the functioning of the chemicals legislation and check whether amendments are necessary.

Finally, more information is being made available to the general public. Currently, the E-PRTR provides environmental information (emissions, waste, discharges) to EU citizens, who live near plants. In the Seveso III Directive, it is stipulated that information about major accidents caused by companies storing large quantities of dangerous substances will also be made available in a database, which is to be made easily accessible by the general public.

The way forward

Although those doing business in the EU need to comply with many different provisions of the law this can also create business opportunities; for example, if you comply with a Regulation in one Member State, you can use the same compliance method in all other Member States.

Furthermore, your opinion matters when the EU checks whether legislation is still efficient, effective and relevant. You are the expert and the one affected by the legislation, which means you are in a position to provide the EU with information necessary to improve its legislation.

Compliance, as well as non-compliance, is being made more and more visible to the general public, and your level of compliance can cast you in a positive light, vis a vis your competitors.

Finally, the EU is working to improve its online tools so you can quickly establish which legislation is applicable to you and help you decide what you need to do in response. An example is the project ‘Open laws’ which can help you easily find legalisation and organise it, making compliance that much easier.

Although the EU is publishing an environmental legislation, this does not directly mean an ever-increasing regulatory burden. There are also opportunities in the EU legislation to help you be and remain successful in business in the EU.

Author: Marlies Huijbers is EHS Legal Advisor at KWA Bedrijfsadviseurs BV

© Chemical Today magazine

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