Pressure Equipment Workshop September 2007 – Day 2 Pressure Equipment Directive Market Surveillance and Role of the Regulator Ed Haynes

Community legislation Member States responsible for Market surveillance Defined in horizontal Articles of Directives Set up in horizontal regulation In the revision of the New Approach, directives may include more specific market surveillance requirements (to be fulfilled by Member States)

Market Surveillance: Safeguard Clause Detection of product on the market which is not safe to be used and/or is dangerous (normally by a national authority) Clarify manufacturer/authorized representative/importer roles by market surveillance If danger persists: withdraw product from the market, notify the Commission and other Member States Investigation by the Commission Commission Decision

Scope Consumer products Products for professional use Priority for products with high potential risks Placing on the market and putting into service

Objective of market surveillance Products should satisfy community legislation Ensure a high level of safety Effective action against non compliant products Functioning information exchange

Need for market surveillance Reduced third party involvement in conformity assessment Competition of Notified Bodies Some Pressure Equipment is consumer product Increasing imports from third countries

Responsibilities of Member States Safety of Pressure Equipment in respect of market surveillance, Article 2 of PED or SPVD Article 2. Notification of Conformity Assessment Bodies Installation and the operation of PE (various approaches in Member States)

Tasks of Member States Establish a market surveillance system Ensure adequate resources Empower their authorities to take necessary measures Draw up market surveillance programmes Establish information and cooperation systems

Role of the Commission Perform procedures of the safeguard clause (PED Article 8) and SPVD Monitor Member States in regard of free movement of Pressure Equipment Set up European co-operation and information on market surveillance Coordinate common market surveillance projects

Role of the Notified bodies Notified Bodies have an essential safety function in a global market If lower safety levels are accepted, their role becomes counterproductive Increasing importance of Member States Authorities monitoring Notified Bodies

Product Safety Directive (PSD) For PE used as consumer products like vessels for air compressors, pressure cookers, the PSD also applies For industrial Pressure Equipment only the relevant Articles of SPVD or PED apply

Specific problems in P E Identification of defects New approach allows different technical solutions High potential risks Imports from outside Europe Consumer products as well as products for professional use High number of consumer products

Experience Most identified problems are with relatively cheap mass products (simple pressure vessels, pressure cookers) However, a “small” risk per item may generate a substantial risk for accidents due to the large number of products. Sometimes difficult to distinguish responsibilities amongst manufacturer, distributor, authorized representative, e.g. insufficient labeling, access to documentation

Overview

Incomplete fusion

Formal problems Formal safeguard procedures take a long time Member States unlikely to use safeguard clause if problem is solved internally Other Member States receive information too late or no information at all

Detection of non compliant PE Use of information tools like ICSMS, RAPEX, CIRCA National Authorities must provide the information to these systems and in time Information on test results and possible distribution channels

Cooperation on European level ADCO Group Sectoral group of National Authorities and the Commission Exchange expertise, develop best practices Set up and carry out shared market surveillance programmes Share information when non compliant pressure equipment is detected Cooperate on measures against dangerous products

Administrative Co-operation Individual Member States have limited resources but collective strength ADCO groups WGA & WPA established in 2004 Comprise representatives from public administrations only Information exchange, co-operation, common concepts and actions for the surveillance/designation of products and notified bodies Chaired by Member States, supported by the Commission Regular meetings, web-based communication (CIRCA, ICSMS) “Constitution” established May extend ADCO activities with the revision of New Approach WG 6 (Article 6) and OAEn procedure (Vademecum) 2006/2007

The Manufacturer Person who is responsible for designing and manufacturing a product, with a view to placing it on the Community market, on his own behalf. obligation to ensure that product is designed and manufactured, and its conformity assessed, all to the Essential Requirements in applicable New Approach directives. May use finished products, ready-made parts or components, or may subcontract these tasks. However, he must always retain the overall control and have the necessary competence to take the responsibility for the product.

The Authorised Representative Any natural or legal person appointed by the manufacturer to act on his behalf. Must be established inside the Community. May be addressed by authorities of the Member States instead of the manufacturer with regard to obligations under a New Approach directive. Manufacturer remains generally responsible for actions carried out by an authorised representative on his behalf.

International Co-operation http://ec.europa.eu/enterprise/pressure_equipment/index has details on Mutual Recognition Agreements, Agreements on Conformity Assessment and Acceptance of Industrial Products This includes positive relationships with countries in the Eastern Mediterranean, North Africa and some of the former Soviet Republics and parts of former Yugoslavia not presently in EU. In some cases this involves legislation based on or similar to the European Directives and / or the role of standards