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AM-Motion Regulatory, EHS and IPR Framework and Actions Draft Report

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AM-Motion Regulatory, EHS and IPR Framework and Actions Draft Report Ref. Ares(2018)155843 - 10/01/2018 H2020 Call FoF-05-2016 AM-motion A STRATEGIC APPROACH TO INCREASING EUROPE’S VALUE PROPOSITION FOR ADDITIVE MANUFACTURING TECHNOLOGIES AND CAPABILITIES Grant Agreement No 723560 Regulatory, EHS and IPR framework and actions draft report Deliverable number: D3.3 Document Details Due date of Deliverable M14 Lead Contractor for Deliverable: PRODINTEC Dissemination Level: PU Contributors: EPMA CECIMO AIRBUS SIEMENS MATERIALISE Deliverable D3.3 Table of Contents 1 Introduction ............................................................................................................................ 4 2 Intellectual Property Rights ................................................................................................... 5 2.1 Patents and Utility Models....................................................................................................................6 2.1.1 Patent application trends ..............................................................................................................6 2.2 Design Rights .................................................................................................................................... 13 2.3 Copyright ........................................................................................................................................... 14 2.4 Trade Mark ........................................................................................................................................ 19 2.5 Liability and Infringements ................................................................................................................ 19 2.6 A look on IPR for AM technology users and related agents ............................................................. 22 2.6.1 A landscape that involves multiple stakeholders ....................................................................... 22 2.6.2 Study cases ............................................................................................................................... 23 3 Regulation ............................................................................................................................. 30 3.1 General Framework for regulation of Additive Manufacturing .......................................................... 30 3.2 AM Raw Materials Regulation in Europe: REACH and CLP ............................................................ 30 3.2.1 REACH Regulation .................................................................................................................... 31 3.2.2 CLP Regulation .......................................................................................................................... 32 3.2.3 Raw Materials regulation beyond Europe .................................................................................. 33 3.3 AM Machines Regulation in Europe: CE-Marking ............................................................................ 33 3.3.1 CE Marking for Manufacturers ................................................................................................... 35 3.3.2 CE Marking for Importers and distributors ................................................................................. 37 3.3.3 AM Machines Regulation abroad ............................................................................................... 38 3.4 AM products regulation ..................................................................................................................... 38 3.4.1 Different sectors, different “regulations”. ................................................................................... 39 3.4.2 A view on sectors in the vanguard of AM regulation: Medical Sector ....................................... 39 3.5 Global Trade of AM Goods ............................................................................................................... 40 4 Environmental impact of Additive Manufacturing Technologies ...................................... 42 4.1 Overview of the AM Process from an environmental point of view .................................................. 42 4.1.1 Basics for understanding AM environmental impact ................................................................. 42 4.1.2 Understanding the environmental impacts of AM ...................................................................... 43 4.1.3 Different AM technologies, different environmental impacts ..................................................... 44 4.1.4 AM a step of a whole lifecycle ................................................................................................... 45 4.2 Quantitative Assessment of AM technologies environmental impacts ............................................. 48 5 Health and safety .................................................................................................................. 50 5.1 Understanding health and safety impacts: Additive manufacturing process .................................... 50 Page 2 of 58 Deliverable D3.3 5.2 Different AM technologies, different health and safety risks. ............................................................ 51 5.2.1 Powder Bed Fusion.................................................................................................................... 51 5.2.2 Fused Deposition Modelling. ..................................................................................................... 54 5.2.3 Other AM Technologies ............................................................................................................. 55 6 Summary and conclusions .................................................................................................. 56 Page 3 of 58 Deliverable D3.3 1 Introduction The present document constitutes Deliverable D3.3 in the framework of the AM-Motion project “A strategic approach to increasing Europe’s value proposition for Additive Manufacturing technologies and capabilities” (Project Acronym: AM-motion; Contract No.: 723560). This document is the result of the activities performed within task T3.1 “Regulatory, EHS and IPR frameworks assessment”, within the framework of work package 3 (WP3), titled “Analysis of Non Technological Aspects”. This document is intended to provide a global view on four non-technological factors associated with additive manufacturing (AM) technologies, which are currently considered to be highly relevant in order to ensure maximum implementation and development of these technologies over the next years: - Intellectual Property Rights. The fully digital nature of additive manufacturing technologies and attached to it, the possibility that a 3D file can be reproduced by any organization or user with access to additive manufacturing means, opens up a new dimension for the consideration of the property rights associated to the creation, distribution, exploitation and general management of designs and products. - Regulation. The emergence of AM is an important turning point when it comes to verifying how existing legislative frameworks can (if this is required) include the capacities and consequences of the use of these technologies. - Environmental impact. Additive manufacturing technologies introduce new manufacturing systems with their own characteristics, which can be analysed from the point of view of the reduction or increase of impact that they can entail, compared to previously existing manufacturing technologies. - Health and Safety. Like any other technology, people play an important role in the manipulation of additive manufacturing technologies and their associated materials and operations, so it is also necessary to consider the risks and prevention measures associated with them. Thus, this document provides an overview of these aspects as a basis for the detection of possible gaps and needs to be tackled in order to accelerate the market implementation of AM technologies. Page 4 of 58 Deliverable D3.3 2 Intellectual Property Rights Technological developments bring both opportunities and challenges for the distribution and control of Intellectual Property (IP) assets1. ICT, and now additive manufacturing, have facilitated the dissemination of IP assets in dematerialised form and allowed the development of new distribution models. Easier distribution has however also significantly increased difficulties in controlling unauthorised distribution of IP assets, and in enforcing IP rights. AM technologies will allow almost anyone to recreate any existing product design, change, and manufacture the product, and use or distribute it (and its 3D CAD-STL file). Therefore, AM may stress the patent system in the same manner that the digital revolution, the Internet, and file sharing stressed the music industry and the copyright system2. From the point of view of the owner of the intellectual property right, there is only a limited number of ways to protect its intellectual property for any kind of product or idea. This is not different for AM-parts. It is however a problem that most tools to protect physical products are defined with large series production of identical products in mind. One of the major advantages of AM is that small series and even unique parts become economically viable to produce. This does however not mean that the standard protection tools cannot be used for AM-parts. They just need to be formulated in the correct way. Additionally, the increasing diffusion and implementation of AM technologies (both at industrial
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