The instrument of the delegated act is used to adapt European legislative acts to scientific and technical progress. What does this mean in practice, and what potential influence does it have on standardization?
European Union (EU) law can be divided into primary and secondary legislation. Primary legislation comprises the EU treaties, the Charter of Fundamental Rights and the general legal principles of the European Court of Justice. Secondary legislation includes all acts adopted by the European Parliament and the Council by means of which the EU exercises its powers. Beyond this, the Treaty on the Functioning of the EU (TFEU) defines a hierarchy within secondary legislation: legislative acts, delegated acts and implementing acts.
Legislative acts are acts adopted under the ordinary or special legislative procedure (Article 289 TFEU). Examples are directives and regulations. The 2009 Lisbon Treaty introduced delegated and implementing acts, which have the purpose of specifying legislative acts further after they have been adopted.
Delegated acts are passed by the European Commission and do not have the character of law. Their purpose is to amend or add non-essential provisions. They usually serve to adapt legislation to technical and scientific progress. This instrument is set out in Article 290 TFEU. Legislative acts may delegate the powers required for this purpose to the Commission; the European Parliament and the Council, however, have the power to revoke this delegation of powers. The following conditions also apply:
Before the Commission passes a delegated act, groups of experts are consulted in which all Member States are represented. Once the Commission has passed the delegated act, the Parliament and the Council have two months in which to review it. Only if no objections are raised can the delegated act enter into force.
By contrast, implementing acts under Article 291 TFEU serve to establish harmonized rules for the implementation of legislative acts. The Member States are responsible for this implementation. In areas where harmonized conditions are required for the implementation of binding legislative acts (such as health, the Single Market), the right to pass implementing acts is conferred upon the Commission, or – in reasoned special cases – upon the Council. During drafting of implementing acts, a group of experts comprising representatives of the Member States is consulted (a procedure termed “comitology”).
A glance at the inter-institutional register of delegated acts introduced in December 2017 shows that their use has long ceased to be an exception. The instrument first emerged within the framework of the Medical Devices Regulation. For example, in order to assure the protection of users’ safety and health and other aspects of public health, the Commission is empowered to use a delegated act to make amendments to Annex IV of the Regulation, i.e. to amend the minimum information required for the EU declaration of conformity.
The example of the Regulation on personal protective equipment (PPE Regulation) shows that delegated acts permit a swifter and more flexible response to innovations, as they enable amendments to be made to non-essential aspects without the need for a lengthy legislative process. In the PPE Regulation, delegated acts may be used to amend the categories of hazards specified in Annex I against which PPE is intended to protect users, and to reclassify hazards. Prior to this, it would have been necessary to amend the PPE Directive by a legislative procedure. This resulted in Annex I not being updated for over 20 years.
In the case of the proposal for a regulation to recast the Machinery Directive, the envisaged delegated acts also simplify support of the Directive. In this case, the instrument has the purpose of adapting the list of high-risk machinery products set out in Annex I and the list of safety components set out in Annex II.
Delegated acts are to be used much more extensively in the recast of the Construction Products Regulation currently under discussion, including in the area of product safety. Under Article 4 (3) of the proposed Regulation, the Commission is to be empowered to pass delegated acts specifying essential characteristics and assessment methods for certain product families and categories. This would enable it to support the Regulation with secondary regulations containing technical requirements. In the Commission’s view, this is necessary where delays or shortcomings arise during the development of harmonized standards, or where standards are lacking entirely. The occupational safety and health lobby regards this as a problem, as it requires an additional step for product safety requirements to be specified in standards. Should the Commission fail to pass delegated acts on product safety, the relevant requirements of the Regulation are meaningless.
It remains to be seen to what extent the Commission will actually use the powers it has been granted to pass delegated acts. The standardization community should certainly continue to monitor this instrument, particularly with regard to the use of delegated acts to specify technical aspects. At the same time, however, this instrument presents an opportunity for changes to be made more swiftly and flexibly and account taken of technical and scientific progress.