This presentation delves into critical environmental regulations and requirements, focusing on the European Union's RoHS and REACH directives. It outlines the fundamental aspects of the RoHS directive, including its scope, basic rules, exemptions, technical documentation, and the CE mark.
RoHS
The gist of the European Union (EU) RoHS Directive:
https://www.getenviropass.com/europe-rohs/
- The scope
- Basic rules
- Exemptions list
- Technical documentation
- CE mark
Countries with RoHS regulations outside of the EU
EU REACH
What is it? How does REACH apply to articles?
https://www.youtube.com/watch?v=KnnoY4Byt8s&t=2s
• Article 33
• Substances of Very High Concern - SVHC
• The once an article, always an article principle
• The SCIP database and notification process (https://echa.europa.eu/scip)
• Annex XVII
Other Product Environmental Requirements
They include:
• Substance restrictions in products.
• Obligations to declare substance above certain thresholds.
• Declarations of products places into a specific market and Waste of Electrical and Electronic Equiment (WEEE)
• Energy efficiency.
• Conflict Mineralsè.
• Standards like ISO 14001 and IEC QC 080000
How to Comply with Substances Control
This section compares:
• analytical testing, such as the X-Ray Fluorescence (XRF) method for the detection of heavy metals; and
• documentary review, following standard IEC 63000
The presentation has been meticulously prepared by Aury Hathout from Enviropass, a leading expert in environmental compliance. For more information, visit: https://www.getenviropass.com/contact/
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RoHS, REACH, and Other Environmental Requirements
1. RoHS, REACH, and Other Environmental Requirements
Presented by Aury Hathout M.Env, CEA
Enviropass Expertise Inc.
contact@getenviropass.com
For the exclusive use of the audience registered in this training, any reproduction without the permission of the author is prohibited
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3. This is not an
exhaustive
presentation
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Warning: This presentation provides basic information on
environmental regulations. It is based on the current
understanding of Enviropass Expertise. It is developed solely for
information purposes and can not replace official legislation
4. Training Plan
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1 – RoHS
2 - REACH
3- Other Environmental Requirements
4 – How to Comply with Substances Control
5. The EU RoHS regulation
Directive 2011/65/EU
and amendments
(2015/863 and others)
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9. 4 Additional Substances
Have been added to the European list of restricted
hazardous substances in electrical and electronic
products. These additional substances are typically
found in plastics.
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Substance
CAS #
Bis(2-ethylhexyl) phthalate (DEHP) 117-81-7
Benzyl butyl phthalate (BBP) 85-68-7
Dibutyl phthalate (DBP) 84-74-2
Diisobutyl Phthalate (DIBP) 84-69-5
Note: A fifth substance, the Hexabromocyclododecane (HBCD or
HBCDD, CAS # 3194-55-6) has finally been removed
10. IMPORTANT : Requirement for conformity at
the homogeneous material level ≠ at the
component level
Article 3
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12. Up to date applicable exemptions should be stated on
the manufacturer’s declaration of conformity (DoC).
If no exemption is claimed, this should also be
specified on the DoC.
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EU RoHS exemptions
Example:
6c: Copper alloy containing up to 4 % lead by weight.
Expired exemptions
• Example: Exemption 7c-III Lead in dielectric
ceramic in capacitors for a rated voltage of
less than 125 V AC or 250 V DC.
13. EU RoHS exemptions
Can also be replaced
• Example:
6a. Lead as an alloying element in steel for
machining purposes and in galvanized steel
containing up to 0.35 % lead by weight.
As of July 1st 2019
6a1. Lead as an alloying element in steel for machining
purposes containing up to 0.35 % lead by weight and in
batch hot dip galvanised steel components containing
up to 0.2 % lead by weight
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14. For the up-to-date list of exemptions:
https://www.getenviropass.com/europe-rohs/
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15. Technical Documentation
Manufacturers must:
draw up the required technical documentation and carry out
the internal production control procedure (…) or have it
carried out;
Directive 2011/65/EU art. 7(b)
ensure that procedures are in place for series production to remain in conformity. Changes in product
design or characteristics and changes in the harmonised standards or in technical specifications by
reference to which conformity of EEE is declared shall be adequately taken into account;
Directive 2011/65/EU art. 7(e)
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16. 2011
RoHS 2 (recast)
Stated goal: better control of electronic waste
Unavowed goal: non-tariff barrier to take over from the internal market
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Source: www.getenviropass.com
Global Approach (Blue Guide)
18. Training Plan
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1 – RoHS
2 - REACH
3- Other Environmental Requirements
4 – How to Comply with Substances Control
19. The REACH Regulation and the Articles in
less than 3 minutes
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https://www.youtube.com/watch?v=KnnoY4Byt8s&t=2s
20. Obligation Communication of
information on substances in
articles
(chapter 3)
Legal basis in REACH Regulation Article 33
Actors concerned Article suppliers
Substances concerned Substances included in Candidate
List of Substances of Very High
Concern for authorisation
Tonnage threshold -
Concentration in article threshold 0.1% (w/w)
No possible exemption from obligation on the basis of :
- Substance already registered for that use (Art. 7(6))
- Exclusion of exposure (Art. 7(3))
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21. IMPORTANT : New rule with REACH:
Once an article, always an article
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22. REACH SCIP Database
Substances of
Concern
In articles, as such or in
complex objects
(Products)
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https://echa.europa.eu/scip
Substances of Concern In articles as such or in complex objects
(Products)
SCIP Notifications
SCIP Notifications
23. Annex XVII
Exemple of substances likely to be found in
EEE:
Nickel compounds - Nickel
Possible presence in parts that are can be
touched by the user (e.g. buttons, casing,
viewfinders etc.)
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24. Training Plan
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1 – RoHS
2 - REACH
3- Other Environmental Requirements
4 – How to Comply with Substances Control
25. EU RoHS
POP
China RoHS
Prop. 65 REACH
TW RoHS WEEE
Energy
efficiency
Product
Sales
Restrictions
Declarations
ISO 14001
IEC QC 080000
Conflict
Minerals
ELV
Packaging
Australia
Product
Stewardship
Substances
Take back
Batteries
Transparency in Supply Chains
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FSC
Greenguard
TSCA-PBT
26. Training Plan
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1 – RoHS
2 - REACH
3- Other Environmental Requirements
4 – How to Comply with Substances
Control
27. What approach should be adopted ?
Analytical testing or documentary review ?
2 sources of information:
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29. • Standard IEC 63000-2018 :
• Objective: ‘to specify the
technical documentation that the
manufacturer needs to compile in
order to declare compliance with
the applicable substance
restriction’ (Introduction)
(EN 50581-2012)
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30. In the introduction of Standard IEC 63000
Technical documentation for the assessment of
electrical and electronic products with respect to
the restriction of hazardous substances
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IEC 63000 recommends technical documentation
with documentary review for complex products.