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importer must ensure the manufactur- er has correctly fulfilled obligations under the EU market requirements. In particular, they must ensure the man- ufacturer has complied with the appropriate conformity assessment procedure and the product is accompa- nied 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 manufactur- ers 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 mark- ing and EU directives. It is available as a free document from the EU Commis- sion (go to DocsRoom/documents/16210). IMPACT ON THE VALVE INDUSTRY M IKE N ORMAN is the director for Product Assurance for DNV GL Business Assurance, North America (, a global certification compliance body. Reach him at VALVE MAGAZINE ence 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 under- stand that article 48 of the PED identi- fies 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 mar- ket 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. VM SUMMER 2016 The good news for the pressure equip- ment and valve industries is that the technical requirements, which are known as essential safety require- ments, 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 Classifi- cation, Packaging, and Labeling (CLP) Regulation replaced the Dangerous Sub- stances 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 inter- vals. During these visits, the notified body establishes that the manufactur- er 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 require- ments for retention of technical docu- mentation. The significant change for imple- mentation 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 surveil- lance (Modules D/D1, E/E1, H/H1), the manufacturer’s declarations and technical documentation must refer- 39