This document outlines the reporting obligations under the European regulation regarding substances of very high concern (SVHC) in articles, particularly focusing on Articles 33 and 7. It emphasizes the need for suppliers to inform downstream users if SVHC is present above 0.1% and reviews exemptions from notifications. The impact of the European Court of Justice ruling and industry responses to the 'once an article always an article' principle are also discussed, highlighting the complexities of compliance and reporting practices.

1. © 2016 SUKHRAJ TAKHAR ALL RIGHTS RESERVED
Substance Reporting
Disclaimer: The intention of this presentation is to highlight the reporting obligations
(specifically under Once An Article Always An Article (O5A))
Created by: Raj Takhar, PhD Researcher
First Published: August 2016

2. © 2016 SUKHRAJ TAKHAR ALL RIGHTS RESERVED
Contents
• Introduction
• Article 33
• Article 7 (2)
• Article 7 (3-6)
• Once An Article Always An Article (O5A)

3. © 2016 SUKHRAJ TAKHAR ALL RIGHTS RESERVED
Introduction
This document is part of a series of LinkedIn posts
authored by myself entitled “Searching the path
towards sustainable chemical substance reporting.”
Please spare some time to read through the posts
as they are an integral part of understanding this
presentation topic.
If you have any comments, please email me
sukhrajtakhar@hotmail.com.

4. © 2016 SUKHRAJ TAKHAR ALL RIGHTS RESERVED
Article 33
• The article supplier must inform the recipient
(downstream user) or consumer, that one or
more constituent articles may contain
presence of an Substance of Very High
Concern (SVHC) in a concentration above 0.1%
w/w.
• The article supplier should provide as a bare
minimum the name of the SVHC in question.

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Article 7 (2)
• Notifications are required if article producers /
imports can meet all of the following conditions:
– Substance is on the SVHC candidate list.
– SVHC presence on an articles produced and/or
imported is > 0.1 w/w concentration.
– Total amount of SVHC usage, in articles which are
produced or imported into Europe, exceed 0.1% w/w
and are imported in volumes which exceed 1 tonne
per annum.
• This was the pre-Once An Article Always An
Article position.

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Article 7 (3 to 6)
• Exemptions from notifications are applicable
under 2 conditions:
– (a) The substance is already registered for that
same use or the substance use is the same as one
of the uses described in the registration of use.
[Review SDS/MSDS/eSDS Data]
– (b) Exemption based on “exclusion of exposure”,
this is where the producer or exporter has
ensured exclusion of any exposure to humans and
environment.

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O5A (i)
• The European Court of Justice (ECJ) ruling, September
2015, states:
– Article 7(2) of Regulation (EC) No 1907/2006, interpreted
as it is down to the producer of an article, or an importer
of an article (which could be made from several articles) to
determine if a SVHC exists in a article at >0.1% w/w.
– Article 33 of Regulation No 1907/2006, interpreted as the
supplier of an article, or an article made from up from
articles, where an SVHC exists in a article at >0.1% w/w,
has a duty to inform as a bare minimum the name of the
SVHC in question, to the article recipient. Upon request of
a article consumer, the information has to be provided.

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O5A (ii)
• Much debate, discussion and angst occurred
over the O5A discussion.
• It should be noted that Article 33 does not
require an organisation to report on the
precise location (for example on part number
xxxxx) or the exact amount found (xx%).

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O5A (iii)
A few of the implications of O5A are shown in the figure below:
Implications of Article 7,
33, 36, 57 and O5A
Customer
Declarations
Article 7 (2)
Article producers /
importers has to
determine if SVHC exists
> 0.1% w/w
Trigger point for
chemical substance
reporting
ECJ Ruling
Record lower level
assembly data
Article 33
Once An Article
Always An Article
Much more recording of
information (sub-component
à specification à
substance(s) / mixture(s) à
supplier declarations)
Candidate list
SVHC substance
Article 36 (1)Recommends
compliance
assessments
Requires
Requires
SVHC > 0.1% Then
bare minimum
reporting
Best Practice Guidance
Statement (Substance
Name & Article
Description Name)O5A
Analyse
Everything
Report
Everything Report
Sensibly
Too Much
Data
Consumer
Reporting
Needs
Article 57
Exemptions from
Notifications
Already
registered use.
Existing use’s
already
registered
Simple O5A and
Safe Use
Guidance
Statement

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O5A (iv)
• In reality there are numerous ways to present the
data. O5A is unique in that it opened up a range
of competing industry position debates to occur,
with each industry sector competing with each
other to define the precise "Gold Standard" for
their industry.
• This is where the power of trade associations
should of enabled an open debate, to bring
cohesion regarding reportable data, either: bare
minimum (SVHC name) or bare minimum plus
(SVHC name and part description).

11. © 2016 SUKHRAJ TAKHAR ALL RIGHTS RESERVED
O5A (v)
• Some trade associations adopted a consensus approach, which really does
simplify O5A reporting, however others point blank refused to accept the
commonality approach, which was a real shame, using stance was "We
shall only report on the bare minimum data i.e. substance name and not
on the part description or part number level" .
• The figure below presents some of European and non-European
perspectives:
· Reporting against EU REACH is standard way of doing
business.
· IT Reporting systems are in place / being developed /
extended.
· Supply chains have established reporting mechanisms for
identifying SVHC data.
· Obtaining good data requires constant supply chain
engagement to ensure data is provided in a clean and
consistent manner.
· Data provided by supply chains can only be considered ‘best
available’, until such time every tier in an industry supply
chain can provide the data in a consistent manner.
Europe Outside Europe
· Domestic chemical regulations seen as higher priority over
European regulations.
· Resistance to reporting substance level data, across tiers of
a supply chain.
· Lack of awareness where articles are used and how – this
data is considered proprietary, resistance to providing
customer declarations.
· Supply chain substance reporting is less mature.
· Contractual requirements need to be established, between
tiers to provide required levels of substance reporting.
· There is not much regulatory / contractual requirements
outside of Europe which require the need to provide
substance reporting data.

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O5A (vi)
• The point which should not be forgotten is SVHC
reporting is here to stay, and reporting against just a
SVHC name and part description, is a lot more easier
than reporting at part number and location layer.
• Suggested best practice reporting statement to fulfil
O5A and safe use guidance information:
The following Substances of Very High Concern [SVHC(s)], may be found within this
article and its constituent sub-components, at greater than 0.1% w/w:
SVHC Substance Name Article / Sub-Component Where Found
****** Bolt, Nut, Washer
**** Pipe
**** *** *** ** Seal
******** Bearing
Please take appropriate safety precautions when handling the above article types.
Further information is available upon request: EHS@anycompany.com

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References
1. 'European CHemical Agency [ECHA] - Guidance on
requirements in articles', Version 4.0, July 2016.
Contact Me
sukhrajtakhar@hotmail.com