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European internal market.

Module D: Regulation of the internal market.

Chapter 5: Regulatory structures and actors: delegated acts, implementing measures and regulatory agencies – private and self-regulation.

Agencies
“A delegation of powers cannot be presumed. Even when empowered to delegate its powers the delegating authority must take an express decision transferring them. [...] To delegate a discretionary power to bodies other than those which the Treaty has established to effect and supervise the exercise of such power each within the limits of its own authority, would render less effective the guarantee resulting from the balance of powers established”: Case 9/56 Meroni, ratio refined in Case C‑270/12 UK v Parliament and Council (ESMA short-selling). The founding regulation’s legal basis is that of the relevant policy area: Case C-217/04 UK v Council (ENISA). The common approach revamped the agencies’ governance, functioning, and oversight.

Delegated acts and implementing acts
The principles of conferral, subsidiarity, and proportionality are set out in Article 5 TFEU and complemented by Protocol 1 on the role of national parliaments and Protocol 2 on subsidiarity and proportionality. Delegated acts are provided for in Article 290 TFEU and implementing acts (with committee procedure) Article 291 TFEU. The EU legislature has discretion on which to use: Case C‑427/12 Commission v Parliament and Council (biocides).

Delegated acts
Commission communication on Article 290 TFEU (COM(2009) 673 final) sets out the Commission’s views delegated acts. An example of a basic act providing for delegated acts is Article 16 et seq. of Regulation 2017/1369. Council and Parliament are able to either block a delegated act or revoke the delegation altogether.

Implementing acts with committee procedure
Regulation 182/2011 lays down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (comitology). There are now two types of procedures: the advisory procedure and the examination procedure. The former regulatory procedure with scrutiny continues to apply until the basic act is amended. The examination procedure applies, in particular, for the adoption of implementing acts of general scope and other implementing acts related to specific subject-matter: Article 2.

Under the old comitology decision (1999/468), the legislature is not bound by the guideline for choosing a procedure adopted by itself, but it must give the reasons for departing from it: Case C-378/00 Commission v Parliament and Council (LIFE); no reason is required when the legislature does not depart from the guideline: Case C-122/04 Commission v Parliament and Council (Forest Focus).

On the principle for delegation to committees, there is a distinction “between rules which, since they are essential to the subject-matter envisaged, must be reserved to the Council’s power, and those which being merely of an implementing nature may be delegated to the Commission”: Case C-240/90 Germany v Commission (sheepmeat) citing Case 25/70 Köster.

A (committee) procedure for adding to a positive list must be accessible and comply with the principles of proportionality, sound administration, and legal certainty. Rejection must be based on a full risk assessment and the most reliable scientific data; and must be open to challenge before the courts: Joined cases C-154/04 and C-155/04 Alliance for Natural Health.

The Lamfalussy approach
The Lamfalussy architecture involves four levels:
 * Level 1 (legislative acts) : Adopted by ordinary legislative procedure.
 * Level 2 (delegated acts and implementing acts) : Committee procedure with the European Banking Committee (EBC), the European Insurance and Occupational Pensions Committee (EIOPC), the European Securities Committee (ESC) and the European Financial Conglomerates Committee (FCC).
 * Level 2 (binding technical standards) : Usually the European Supervisory Authorities (ESAs) – the European Banking Authority (EBA), the European Insurance and Occupational Pensions Authority (EIOPA), and the European Securities and Markets Authority (ESMA) – draft the standards for Commission to adopt as regulations or decisions; they “should be technical, shall not imply strategic decisions or policy choices and their content shall be delimited by the legislative acts on which they are based”. Or the Commission drafts, consults, and adopts. The Parliament or the Council can revoke the delegation to the Commission. For regulatory technical standards (delegated acts under Article 290 TFEU) the Parliament or the Council may object; for implementing technical standards (implementing acts under Article 291 TFEU) there is no further scrutiny once adopted.
 * Level 3 (cooperation) : ESAs work on recommendations, guidelines, and standards.
 * Level 4 (enforcement) : Commission guards the Member States’ compliance. The European Systemic Risk Board (ESRB) recommends the Member States against risks; the latter must explain deviations; the Board may bring the matter to the Council.

Standards
For technical standards, Regulation 1025/2012 and Directive 2015/1535 have replaced Directive 98/34/EC, which in turn replaced the original Directive 83/189/EEC.

National standards
Directive 2015/1535 lays down a procedure for Member States to provide information about their technical standards and regulations: A Member State must notify the Commission and only adopt the measure after a standstill period. This protects the free movement of goods, which is one of the foundations of the Union: Case C-13/96 Bic Benelux. Commission may start proceedings after examining the notification: Case C-184/96 Commission v France (foie gras), Case C-230/99 Commission v France (rubber in contact with food).

The full text of the draft legislation must be notified, though the standstill obligation applies only in respect of those parts of the measure that are technical regulations: Case C-279/94 Commission v Italy (asbestos). Unnotified technical regulations adopted by Member States could not be applied to individuals; the directive has direct and horizontal effect: Case C-194/94 CIA Security, confirmed in Case C-443/98 Unilever Italia. This does not mean uses of products that conform to an unnotified standard can be challenged: Case C-226/97 Lemmens.

Even a measure that liberalises existing national legislation may constitute a technical regulation: Case C-273/94 Commission v Netherlands (margarine). National rules prohibiting the marketing and use of asbestos (Commission v Italy (asbestos)) and requiring that disposable razors bear a label stating that they were subject to an ‘eco-tax’ (Bic Benelux) are technical regulations to be notified; but not these:
 * A measure prescribing that labelling be in a particular language (Case C-33/97 Colim): It is no more than an ‘ancillary rule’ necessary for the information on the label to be effectively communicated.
 * A rule determining the first date on which a motor vehicle was put into circulation (Case C-314/98 Sneller’s Autos): It did not define product characteristics.
 * Minimum safety requirements for the use of old electrical installations (Case C-361/10 Intercommunal Intermosane): They laid down general safety requirements without referring to the product.

European standards organisations
Regulation 1025/2012 establishes rules about European standardization organizations for New Approach standardization, these being:
 * 1) European Committee for Standardization (CEN)
 * 2) European Committee for Electrotechnical Standardization (Cenelec)
 * 3) European Telecommunications Standards Institute (ETSI).