The European Union’s (EU) New Legislative Framework (NLF), which was set forth in 2008, has sharpened the focus on importer and distributor responsibilities as they relate to importing or placing CE-marked (European Conformity) products on the market. This focus is reflected in the recasting of several EU directives that affect the valve and equipment industries, including Pressure Equipment Directive (PED) 2014/068/EC and Equipment for Potentially Explosive Atmospheres (ATEX) Directive 2014/ 034/EC.
Along with product manufacturers, importers and distributors are subject to specific obligations in the context of “market surveillance” (a term used in Europe that means monitoring products to ensure they conform to the law).
Since 1987, more than 27 EU product directives have come into force. These directives have the dual purpose of: 1) ensuring the free movement of goods through technical harmonization (alignment of safety objectives) of entire product sectors; and 2) guaranteeing a high level of protection and safety.
This new way of doing things (which is called the New Approach and Global Approach) was a unique and bold change to previous European methods for issuing product safety regulation. As such, it hasn’t been without significant challenges during the implementation.
The New Approach and Global Approach Directives changed the product compliance world by introducing several new regulatory undertakings including:
- Harmonization of safety objectives by all European Economic Area (EEA) member states through risk-based development, rather than prescriptive solutions
- Technical harmonization of product safety through industry-developed product standards
- Recognition of private, third-party conformity assessment bodies (called Notified Bodies) for assessment of higher risk products
- Application of CE Marking on products to identify compliance with EU Directives
- Application of EEA structures for monitoring products placed on the market or put into service in the EEA under the EU Product Directives
After EU Directives were first adopted in 1987 and the new approach had been implemented for several years (including CE Marking and some recasting of initial EU Directives), the EU Commission reviewed the purpose, impact and effectiveness of the system. The result is the revision of the system, which is now commonly referred to as the NLF.
Industry trade associations, conformity assessment bodies, national authorities and the EU Commission technical working groups provided feedback. The feedback addressed variations between member states in regards to enforcement, assessment irregularities between notified bodies and inconsistencies in the technical application of EU Directives. In 2008, as a result of the EU Commission review, the European parliament adopted two regulations that affect the new approach directives. The primary focus of those rules was to:
- Strengthen the value of CE marking
- Put emphasis on member state control of notified bodies
- Strengthen market surveillance (including defining the roles for different parties)
- Align the conformity assessment modules of the global approach system
The first rule was Regulation 765/2008/EC, effective Jan. 1, 2010. The purpose was to provide a common framework for accreditation of conformity assessment bodies within the EU and set the framework for monitoring products in the European market (market surveillance). This was done to guarantee that those products meet requirements, thus ensuring a high level of protection of public interests.
Simply put, the intention of the common framework for accreditation from conformity assessment bodies, including notified bodies, is to reduce disparity and deviations of practices between those bodies.
The framework for monitoring products by all member states was strengthened to clarify responsibilities, follow up on complaints, and monitor accidents and damage to health that these products might cause, as well as verifying corrective actions and following up on notification of dangerous products.
The second rule was Decision 768/2008/EC—A Common Framework for the Marketing of Products in the EU—which also affects future revisions of new approach directives. Decision 768 sets out common principles and procedures that EU legislation must follow when harmonizing conditions for marketing products. It also includes reference requirements that are to be incorporated whenever product legislation (regulations or directives) is revised.
Included in the new directives are clear divisions of responsibility for manufacturers, importers and distributors along the product chain. For example, the directives require that manufacturers (the legal entity taking responsibility for the product) must follow the appropriate conformity assessment procedures and ensure products comply with relevant directives. They also must place the CE marking on the product.
Importers are the economic operators established in the European Union that place a product from a third country on the EEA market. The importer must ensure the manufacturer has correctly fulfilled obligations under the EU market requirements. In particular, they must ensure the manufacturer has complied with the appropriate conformity assessment procedure and the product is accompanied by the necessary documentation and CE marking. If the importer has doubt about the conformity of the product, it cannot place that product on the market.
Distributors are the parties in the supply chain other than manufacturers or importers that make a product available on the market. Distributors need to know which products require CE marking and what documentation must accompany the products. They also must act with due care (perform due diligence) and verify the product has the necessary documentation and CE marking. Distributors must be able to identify the importer or party that provided them with the product. This is required so that market surveillance authorities have a traceability chain for compliance.
The EU Commission published the 2016 edition of The Blue Guide on Implementation of EU Product Rules in April. This guide clarifies roles and many other issues related to CE marking and EU directives. It is available as a free document from the EU Commission (go to http://ec.europa.eu/DocsRoom/documents/16210).
IMPACT ON THE VALVE INDUSTRY
The good news for the pressure equipment and valve industries is that the technical requirements, which are known as essential safety requirements, have not been changed for the PED or ATEX—the two directives of most concern to those industries. This means technical solutions adopted for compliant products today will remain acceptable when the new directives go into force.
One of the most significant changes in PED affecting the equipment industry relates to the fluid grouping of media contained under pressure. The Classification, Packaging, and Labeling (CLP) Regulation replaced the Dangerous Substances Directive (DSD) 67/548/EEC effective June 1, 2016 for PED.
Flammable liquids in the PED are now defined, and that definition is aligned with the CLP, as depicted in Table 3.4 above from the European Commission Impact Assessment Study.
The conformity assessment modules for PED have seen very minor changes that will have no practical impact on manufacturers. Modules A1 and C1 have been changed to A2 and C2. Also, the notified body’s assessment activity is unexpected visits at random intervals. During these visits, the notified body establishes that the manufacturer actually performs final assessment and takes samples of the product to perform checks.
Modules B (EC Type Examination) and B1 (EC Design Examination) have been renamed Module B, with product and design examinations carrying the same 10-year validity and requirements for retention of technical documentation.
The significant change for implementation of the new PED is a sharp transition date (which means no grace or transition period). Products placed on the market or put into service before July 19, 2016 must be declared compliant with 97/23/EC; however, after that date all pressure equipment must be declared compliant with 2014/068/EC.
For manufacturers operating under quality management system surveillance (Modules D/D1, E/E1, H/H1), the manufacturer’s declarations and technical documentation must reference Directive 2014/068/EC after July 19, 2016. However, the notified body’s certificate can still reference the old directive until the expiration date.
All technical documentation files for equipment supporting compliance with PED must be updated to reflect the new PED. Manufacturers should have this completed by the July 19 implementation date.
Manufacturers also should understand that article 48 of the PED identifies that equipment manufacturers certified according to 97/23/EC before the implementation date for 2014/ 068/EC remain valid after the new directive goes into force. However, this point may require clarification with customers and end users expecting certificates according to the new directive.
For the ATEX directive (2014/34/ EC), the transition date to the new directive was April 20, 2016. As with the PED, this is a sharp transition date and all equipment placed on the market or put into service must be declared in conformance with the new ATEX directive. Also, just as with PED, equipment manufactured and certified to 94/9/EC before April 20, 2016 has to remain valid after the new directive goes into force.