ENVIRONMENTAL, HEALTH AND SAFETY LEGISLATION IN EUROPE€¦ · 1 September 28, 2015 COCIR WEBINAR...

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


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


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


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


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


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

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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%


• 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


• 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


• 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


IEC62474: Material Declaration for Products of and for the Electro technical Industry

Aim: • harmonize substance requirements across the supply chain • improve economic efficiencies


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.


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


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


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, …)


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)


approved tool

Recent analysis report 3)

required from a certified lab


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

[email protected]

ENVIRONMENTAL, HEALTH AND SAFETY LEGISLATION IN EUROPE€¦ · 1 September 28, 2015 COCIR WEBINAR...

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Transcript of ENVIRONMENTAL, HEALTH AND SAFETY LEGISLATION IN EUROPE€¦ · 1 September 28, 2015 COCIR WEBINAR...