ENVIRONMENTAL, HEALTH AND SAFETY LEGISLATION IN EUROPE

Transcription

1 COCIR WEBINAR Monday 28 September, to ENVIRONMENTAL, HEALTH AND SAFETY LEGISLATION IN EUROPE Trends and threats for the Medical Sector 1 September 28, 2015

2 COCIR WEBINAR Monday 28 September, to CONSEQUENCES FOR INDUSTRY HOW TO COMPLY AND BE PREPARED Hans van der Wel COCIR ENVI Focus Group Chair 2 September 28, 2015

3 CONSEQUENCES FOR INDUSTRY HOW TO COMPLY AND BE PREPARED - Which substances to report on in supply chain - REACH: new ruling of the CoJ - Supporting tools, standards - Substituting hazardous substances 3 September 28, 2015

4 ENVIRONMENTAL PRODUCT LEGISLATION (MEDICAL DEVICES) RoHS (EU): Lead, cadmium, mercury, chromium VI, PBB, PBDE restricted in medical devices per , Abbreviatio Chemical Name Where found CAS No. Restricted per July 2021: n Bis (2-ethylhexyl)phthalate; Di (2-ethylhexyl) phthalate Plasticizer in DEHP Dibutyl phthalate; Di-n-butyl phthalate PVC Cables, DBP Benzyl butyl phthalate; Butyl benzyl phthalate and tubing BBP Diisobutyl phthalate; Di-i-butyl phthalate DIBP Every 4 years additional substances, Beryllium metal and oxide, PVC, Cobalt, Antimony oxide, Arsenic oxides, Indium phosphide, some chlorine, bromine and phosphate flame retardants still being considered REACH (EU): Declare SVHCs (163 substances currently) when >0.1 weight% per article Use of SVHCs in EU manufacturing only for authorized applications: 31 SVHCs from onwards; exempted when authorized under MDD Particular restrictions in Annex17 (105 restrictions), e.g. cadmium in plastics Medical Device Regulation recast (EU): Currently labelling of phthalates in contact applications Restriction of hazardous substances in contact applications (possibly from 2018) Note: the cost for supply chain management for RoHS so far only has been estimated by COCIR around 5 million euros per company 28 September 2015 COCIR Webinar 4

5 Product legislation per substance Substance Legislations (main) Further info RoHS current: lead, mercury, cadmium, chromium VI, PBB, PBDE Phthalates REACH SVHCs RoHS (EU and various other countries), REACH art. 67 ( Pb, Hg, Cd); Califinia Prop 65, and federal USA (Pb), USA state legislations (Hg, PBB, PBDE) Upcoming RoHS ( ), Reach art. 67 and 33, French tubes (DEHP ban), MDD, California Prop 65 REACH article 33, 63 substances may be relevant for EEE currently Restriction Batteries Lead, mercury, cadmium (global) Restriction Halogens CFR, BFR, PVC Phosphate flame retardants, TDCPP, TCEP, TCPP Bisphenol-A REACH SVHC, upcoming RoHS (PVC, tetrabromo-bisphenol-a, clorinated paraffines, after 2020?) USA state legislations, EU toys directive ( ) Restricted in food containers, upcoming legislation for other applications Restriction and declaration Declaration (0.1% weight/per article) Declaration and future restriction Restriction Restriction and declaration PAHs Various, e.g. Reach Article 67, German legislation Restriction and declaration RoHS additional upcoming (after 2020?) EU: beryllium and its oxide, antimony trioxide, nonylphenols, di-arsenic pentoxide and di-arsenic trioxide, cobalt, Indiumphosphide, Upcoming restriction 28 September 2015 COCIR Webinar 5

6 REACH Ruling of the EU Court of Justice on article definition WHAT HAPPENED 6 EU member states had differing explanation for an article compared to other member states and the EU commission since a few years: an article continues to be an article (yes/no) even when integrated/assembled in another article In January 2015 the EU Court of Justice (CoJ) had an hearing about a case raised by 2 French Federations (FCD and FMB) about the interpretation of obligations in article 7.2 and 33 of REACH. On 10 September 2015 the CoJ released a ruling supporting the view of the few Member States: once an article always an article This will have far reaching consequences on the flow of information through the supply chain for manufacturers. 28 September 2015 COCIR Webinar

7 NOTIFICATION Article 7 (2): notify ECHA on presence of SVHC s in article if the substance is present in the article in quantities totaling over 1 tonne per producer or importer per year; the substance is present in the article above a concentration of 0,1 % weight by weight (w/w). Further information due to the ruling of : Notification only for those articles produced by the producer (if the substance is not registered for that use) or imported from outside the EU No notification is needed for articles supplied from inside EU Note: A complex product may contain many articles, e.g., many printed circuit boards with many electric components. Still to be determined by EU Commission/Countries to what article level notification maybe needed, e.g., printed circuit board or single IC. 28 September 2015 COCIR Webinar 7

8 INFORM CUSTOMERS Article 33: inform customers on presence of SVHC s in article if the substance is present in the article above a concentration of 0.1 % weight by weight (w/w). Further requirements information due to new ruling 2015: Information needs to be provided to customers for all articles within a complex product For those articles coming from within EU, it is the obligation of the supplier to inform their customer. When the customer is not informed, he does not need to generate the info himself to inform his customer For those articles coming from outside EU it is the obligation of the importer to generate the SVHC information and inform the customer Note: A complex product may contain many articles, e.g., many printed circuit boards with many electric components. All can be seen as articles 28 September 2015 COCIR Webinar 8

9 BEFORE COJ RULING <0,1% 28 September 2015 COCIR Webinar 9

10 AFTER COJ RULING 28 September 2015 COCIR Webinar 10

11 RECOMMENDATIONS The ruling has immediate effects, but manufacturers obligation to communicate to customers the content of SVHC refers to available information when supplies from within EU. When no information is available from EU supplies, there is no obligation to source the information in alternative ways (e.g. tests). Manufacturers should continue to ask for REACH SVHC information at the lowest reasonable article level from their suppliers and discuss in trade associations how to deal with the upcoming substance information needs. ECHA and the EC are planning to review the ECHA Guidance on Substances in Articles. Wait for additional guidance to come from the EC, ECHA and COCIR Companies need to work on full substance content information and phase out those substances forecasted to be restricted and those substances which have a health risk, e.g. in contact applications 28 September 2015 COCIR Webinar

12 SUBSTITUTING HAZARDOUS SUBSTANCES RoHS phthalate restriction in 2021, but activities should start already now, to prepare for exemption requests and plan phase out roadmap COCIR developed a guidance to assess the time required for substitution The methodology can be used by companies to plan their activities Having a clear understanding on the time required to substitute prioritized substances is very important for COCIR advocacy activities to ensure reasonable deadlines are included in the legislation 28 September 2015 COCIR Webinar

13 ENABLING SUPPORT IEC62474 material declaration standard UNEP Chemical in Products (CiP) program BOMCheck tool for substance declarations EN standard for technical documentation on substances Others 28 September 2015 COCIR Webinar 13

14 IEC62474: Material Declaration for Products of and for the Electro technical Industry Aim: harmonize substance requirements across the supply chain improve economic efficiencies 28 September 2015 COCIR Webinar 14

15 UNEP CHEMICAL IN PRODUCTS (CiP) PROGRAM To come to a voluntary, international and multi-stakeholder program for information on chemicals in products along the supply chain and throughout their life cycles, with the aim of facilitating and guiding the provision and availability of and access to relevant information on chemicals in products among all stakeholder groups. 28 September 2015 COCIR Webinar 15

16 SUPPLY CHAIN MANAGEMENT 0.1 weight % for REACH SVHC Various thresholds for REACH restrictions 0.1% concentration on the homogeneous material level for RoHS Otherwise regulated chemicals 28 September 2015 COCIR Webinar 16

17 ARCHITECTURE Material Content Data IN Manufacturers Central System Material Content & Compliance Data Compliance Specifications Exemptions OUT Compliance & Material Content Reports IPC 1752 IMDS Custom formats Other BomCheck IN BOM Sources BOM Sources IN Item Master IPC 1752 Reply IPC 1752 Distribute Custom formats Other PLM/PDM/ERP Other AML Other

18 HOW BOMCHECK HELPS COMPANIES One harmonized list of regulated substances One globally shared declaration database Guidance on substances: most of our suppliers have little to no knowledge on chemicals > supports easy declaration of products Guidance on regulations: always the most actual status of restricted substances which secures access to all world-markets Web-based tool, no local IT installation Contains full database of chemical substances allowing Full Material declaration 28 September 2015 COCIR Webinar

19 Challenges with BOMCheck Challenge 28 September 2015 Solution Chemical and material knowledge Maintain BOMcheck guidance to help prioritize relevant substances Provide specific guidelines including risk assessment on components, materials and suppliers and guidance on 3 rd party testing Train suppliers and manufacturer s staff Encourage suppliers to ask any substance related question Various regulations per substance and fast growing # of regulations Start discussions how to improve BOMCheck, split per product group (e.g., toys, childcare,...) or per substance Lack of resources at suppliers Emphasize legal compliance and use of third party support and testing Demonstrate that BOMCheck saves time compared to paper declarations Encourage suppliers to escalate requirements down their supply chain and use BOMCheck for their customers as well. Language problem Further improve BOMcheck and manufacturer s specific guidelines for suppliers in local language User friendliness of BOMcheck Continue improvements through Environ s BOMcheck steering committee with input from OEM users and suppliers Suppliers and their sub- contractors make wrong declarations Correct suppliers, and provide training. Introduce standardized validation process including risk assessment Provide specific guidance per substance, material, component Create more effective process to monitor suppliers progress in BOMcheck tool (e.g. risk assessment, testing, ) COCIR Webinar

20 Substance Risk Management Balancing technical and supplier risks that is As Low As Reasonably Practicable in line with EN 50581; Philips Healthcare approach Supplier Trustworthiness Product Substance Risk Low High A (high) 1 1A B (med) 1 2 C (low) 1 3 Option Evidence 1: Supplier- or Self-declaration 1) 1 in BOMCheck or other approved tool 1A in BOMCheck or other approved tool 2 in BOMCheck or other approved tool 3 in BOMCheck or other approved tool Evidence 2: Testing No testing Random testing 2) Recent analysis report 3) required from a certified lab Recent analysis report 3) required & regular inspection 4) 1) Self Declaration: when fully or partly responsible for the design or when trustful components information(s) or when product substance risk is low 2) Random Testing: On full product, or on all high risk components of product 3) Recent: max. 12 months (or longer - in case evidence of no change is available) 4) Regular inspection: Risk based, either at manufacturer site or at incoming inspection minimal once per year 28 September 2015 COCIR Webinar

21 THANK YOU VERY MUCH FOR YOUR ATTENTION Hans van der Wel