substance reporting

© 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


Contents • Introduction

• Article 33

• Article 7 (2)

• Article 7 (3-6)

• Once An Article Always An Article (O5A)


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 [email protected].

mailto:[email protected]


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.


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.


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.


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.


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%).


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 GuidanceStatement (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


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).


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.


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: [email protected]


References

1. 'European CHemical Agency [ECHA] - Guidance on requirements in articles', Version 4.0, July 2016.

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