Post on 13-Oct-2020
September 28, 2015 1
COCIR WEBINAR Monday 28 September, 10.30 to 12.00
ENVIRONMENTAL, HEALTH AND SAFETY LEGISLATION IN EUROPE
Trends and threats for the Medical Sector
September 28, 2015 2
COCIR WEBINAR Monday 28 September, 10.30 to 12.00
CONSEQUENCES FOR INDUSTRY
HOW TO COMPLY AND BE PREPARED
Hans van der Wel
COCIR ENVI Focus Group Chair
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
COCIR Webinar 28 September 2015 4
ENVIRONMENTAL PRODUCT LEGISLATION (MEDICAL DEVICES)
• RoHS (EU): – Lead, cadmium, mercury, chromium VI, PBB, PBDE restricted in medical devices
per 22-07-2014, – Restricted per July 2021:
– 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 2014-2019 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
Chemical Name Where found Abbreviatio
n CAS No.
Bis (2-ethylhexyl)phthalate; Di (2-ethylhexyl)
phthalate Plasticizer in
PVC Cables,
and tubing
DEHP 117-81-7
Dibutyl phthalate; Di-n-butyl phthalate DBP 84-74-2
Benzyl butyl phthalate; Butyl benzyl phthalate BBP 85-68-7
Diisobutyl phthalate; Di-i-butyl phthalate DIBP 84-69-5
COCIR Webinar 28 September 2015 5
Product legislation per substance
Substance Legislations (main) Further info
RoHS current: lead, mercury, cadmium, chromium VI, PBB, PBDE
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)
Restriction
Phthalates Upcoming RoHS (2019-2021), Reach art. 67 and 33, French tubes (DEHP ban), MDD, California Prop 65
Restriction and declaration
REACH SVHCs REACH article 33, 63 substances may be relevant for EEE currently
Declaration (0.1% weight/per article)
Batteries Lead, mercury, cadmium (global) Restriction
Halogens CFR, BFR, PVC
REACH SVHC, upcoming RoHS (PVC, tetrabromo-bisphenol-A, clorinated paraffines, after 2020?)
Declaration and future restriction
Phosphate flame retardants, TDCPP, TCEP, TCPP
USA state legislations, EU toys directive (21-12-2015) Restriction
Bisphenol-A Restricted in food containers, upcoming legislation for other applications
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
COCIR Webinar 28 September 2015
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.
REACH Ruling of the EU Court of Justice on article definition
COCIR Webinar 28 September 2015 7
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 10-09-2015: – 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.
NOTIFICATION
COCIR Webinar 28 September 2015 8
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
INFORM CUSTOMERS
9 COCIR Webinar 28 September 2015
BEFORE COJ RULING
>0,1%
>0,1%
>0,1%
<0,1%
>0,1%
>0,1%
>0,1%
>0,1%
>0,1%
10 COCIR Webinar 28 September 2015
AFTER COJ RULING
>0,1%
>0,1%
>0,1%
>0,1% >0,1% >0,1%
>0,1%
>0,1% >0,1% >0,1%
>0,1% >0,1% >0,1% >0,1% >0,1%
COCIR Webinar 28 September 2015
• 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
RECOMMENDATIONS
COCIR Webinar 28 September 2015
• 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
SUBSTITUTING HAZARDOUS SUBSTANCES
COCIR Webinar 28 September 2015 13
• IEC62474 material declaration standard
• UNEP Chemical in Products (CiP) program
• BOMCheck tool for substance declarations
• EN 50581 standard for technical documentation on substances
• Others
ENABLING SUPPORT
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IEC62474: Material Declaration for Products of and for the Electro technical Industry
Aim: • harmonize substance requirements across the supply chain • improve economic efficiencies
COCIR Webinar 28 September 2015 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.
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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
ARCHITECTURE
Manufacturers Central
System • Material Content & Compliance Data
• Compliance Specifications
• Exemptions
BOM
Sources Item
Master
Material
Content
Data
Compliance
& Material
Content
Reports
• IPC 1752
• IMDS
• Custom formats
• Other
• BomCheck
IN
IN
• PLM/PDM/ERP
• Other
• AML
• Other
IN
OUT
• IPC 1752 Reply
• IPC 1752 Distribute
• Custom formats
• Other BOM
Sources
COCIR Webinar 28 September 2015
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
COCIR Webinar 28 September 2015
Challenges with BOMCheck
Challenge 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 3rd 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 28 September 2015
Substance Risk Management
Balancing technical and supplier risks that is As Low As Reasonably
Practicable in line with EN 50581; Philips Healthcare approach
Supplier Trust-worthiness
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)
Evidence 2: Testing
1 in BOMCheck or other
approved tool
No testing
1A in BOMCheck or other
approved tool
Random testing2)
2 in BOMCheck or other
approved tool
Recent analysis report 3)
required from a certified lab
3 in BOMCheck or other
approved tool
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
THANK YOU VERY MUCH
FOR YOUR ATTENTION
Hans van der Wel
h.van.der.wel@philips.com