Ref. Ares(2014)78290 - 15/01/2014

Towards a successful implementation of REACH:

What should downstream users
do now?
14 April 2008
A.I.S.E.
GenevièGeneviève Hilgers & Sylvie Lemoine

1

Presentation outline

PART A. Definition of Downstream User (DU)
PART B. What should DUs do now?
B.1. Pre-registration / Registration
B.2. Communication on safe use up and down in the supply chain

PART C. Challenges faced by DUs
PART D. Summary2

PART A. Definition of Downstream User
Outside the EUEUS

Substance

DU uses subst./prep.
in the course of hisindustrial or
professional activities

SDU

Preparation

Se.g. formulator, industrial
user, article producer,
professional, etc.

ArticleS

Note: A distributor or a consumer is not a downstream user3

….but a company can be DU and manuf. orimporter of substances or preparations

EUDU also
Manufacturer
or Importer ofSubst & Prep.

Outside the EU

DU
M/I

In this case, he will have to fulfill duties of manufacturer or importerin addition to DU duties
4

Presentation outline

PART A. Definition of Downstream User (DU)
PART B. What should DUs do now?
B.1. Pre-registration / Registration
B.2. Communication on safe use up and down in the supply chain

PART C. Challenges faced by DUs
PART D. Summary

5PART B.1.
If you use substances or preparations?
EU supplierof EU supplier?
EU supplierPre-reg.

Registration

ÂX Recommendation:
Check that your suppliers will
pre-register and register thesubstances supplied to you(when applicable)

Pre-reg.

Registration

Ö Ask yoursuppliers to do thesame up the supply chain(when applicable)

DU

Note: This is not mandatory but vitalto guarantee supply continuity
through the whole supply chain…

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…because
Pre-reg.

EU supplier of EU supplierNo pre-registration between
June 1, 2008 & December 1, 2008means….
Î No manufacture/import ofsubstanceafter Dec. 1, 2008!

EU supplier

DUÎ No manufacture ofpreparation(s) or article(s) with thissubstance after Dec. 1, 2008
through the whole supply chain!
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PART B.1.
What should DUs do with their suppliers?
Practical approach
First option:
Ö Obtain confirmation from your supplier that he will pre-registerand register the substance
Second option:
Ö Obtain confirmation from your supplier that he will pre-register thesubstance andÖ Reconvene before the registration deadline to confirm intent toregister or notThird option:
Ö Consider alternative EU supplier or become importer
Remember:• Pre-registration is easy
• Pre-registration is not a commitment to register the substance!
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PART B.1.
What should DUs do to further increase
supply certainty?
Be aware of the late pre-registration option
DU has the possibility to pre-register, if he imports a substance forthe 1st time after December 1, 2008 (>1t/y)• provided he submits the pre-registration within 6 months of first import and 12
months before the registration deadline• in this case, the DU becomes an importer i.e. a registrant

Notes:Ö Pre-registration by DU cannot replace supplier pre-registration
Ö In addition, if your substance is not on the pre-registration list in Jan. 2009,
the Agency can provide support on request in finding a new supplier

9PART B.1.
What should DUs do to further increase
supply certainty?
Should a DU pre-register the substances he purchases,
during the pre-registration period (as a potential M/I)?
Ö Maybe (probably exceptionally) if:* the substance is critical for the business and/or* no supplier commitment has been obtained and/or* DU does not want to rely on late pre-registration
Ö Entails participation in SIEF with corresponding rights and duties
Note: Other considerations may lead a DU to pre-register (e.g. role inSIEF if he is “data rich”)
10PART B.1.
If you produce articles

DU

ÂY Recommendation / legal duty:
Pre-register substances which areintended to be released from article(s)(>1t/y)ARTICLES

Note: Registration is not required for substances whichhave already been registered for that specific use (e.g. byyour supplier), but this is unknown at the time ofpre-registration (June 1 – December 1, 2008)11

PART B.1.
If you are also a manufacturer or importer
EU
Only Representative

DUM/I
Non-EU supplier XorÂZ Legal duty:Pre-register all the substances that you
manufacture or import at >1t/y per legal entity
Ö in case of import.. unless your non-EU supplier pre-registers

through an Only Representative: you will become DU
Note: when you pre-register as (potential) M/I, you will have to carry M/I duties
in addition to DU duties

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PART B.1.
If you own dataSIEF?
DataDDataa ta

Â[ Recommendation:
Review the data you own anddetermine if you want to participate
in SIEF as data holder

DU
Note: Applies as per January 200913

Presentation outline

PART A. Definition of Downstream User (DU)
PART B. What should DUs do now?
B.1. Pre-registration / Registration
B.2. Communication on safe use up and down in the supply chain

PART C. Challenges faced by DUs
PART D. Summary

14

PART B.2.
DU rights and duties on safe use communication“Use” can be sharedpro-actively
or reactively

EU suppliers
Annex:ESAnnex:ESSDS (with ES)+ other information- Implement RMM- Communicate SDS (ES)to his own DUs
Annex:ES
Annex:ESSDSSDS- Use and exposure information- Check RMM / ES
- Report new information

SDSSDS

DU1or

DU’s own
Chemical Safety Report(only if used > 1t/y)

DU215

PART B.2.
Communication on safe use down the supply chain
What are the criteria driving to ES development?
Ö Your supplier will only perform ES if all the following conditions are met:
1. Substance is manufactured/imported at >10t/y and2. Substance is classified as dangerous or is PBT/vPvB and3. Substance is present in preparation above a certain concentration level(Art 14 (2))
Notes:- The criteria driving ES requirements are different from criteria driving SDS requirements- No action on ES is required by the DU if no ES is provided in your supplier’s SDS

When will DU receive SDS with ES?
Ö In theory, as per June 1, 2008…In practice, later on (for most substances)

When must DU comply with RMMs communicated via SDS as part of ES?
Ö Within 12 months of receiving SDS of supplier with registration # and ES16

PART B.2.
Making your use identified
Â\ Recommendation:
Decide if you want to share your use pro-actively
with your suppliers but to do it, wait for harmonised
IT tools/questionnaireÖ Pro-active use reporting should be done one year before registration

deadline, i.e. there is still time
Ö RIP 3.2-2 covering use and Exposure Scenario has just been finalizedÖ Use Industry IT-tools/questionnaire once available(currently under development by CEFIC, expected soon)Ö Use standard terminology
e.g. use descriptor system from RIP 3.2-2
e.g. standard RMM (under development)
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PART B.2.
If you receive use information from yourown customers

EU supplier

Â]

DU1
use

Recommendation:
Pass it up in the supply chain
Please wait for the harmonised industry IT-Tools

Or perform the CSR and include ES inSDS (if applicable)

DU2Customer

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There is more to do for DUsÂ^ Additional recommendations:
EU supplier

DU1

Ö Read Guidance for Downstream User
http://reach.jrc.it/docs/guidance_document/du_en.htm

Ö Work with your trade association on sectorspecific or industry-wide approaches to facilitatecommunication
Ö Prepare use information for your suppliers
Ö Answer to your customers (show awareness)

DU2

Ö Keep an eye on candidate list of Substances ofVery High Concern for authorisation

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Presentation outline

PART A. Definition of Downstream User (DU)
PART B. What should DUs do now?
B.1. Pre-registration / Registration
B.2. Communication on safe use up and down in the supply chain

PART C. Challenges faced by DUs
PART D. Summary

20

PART C.
Challenges faced by DUs¾ Reliance on suppliers both for pre-registration/registrationand coverage of identified use→ even greater challenge for SME’s¾ REACH requirements change frequently in innovative companies¾ Uncertainties of (pre-)registration scope e.g. Annexes IV-V
¾ Manage flow of communication effectively¾ Understand how to generate Exposure Scenarios for preparations¾ Delays in TGD publication (e.g. RIP 3.2-2 and 3.8) and IT Tools
development
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Presentation outline

PART A. Definition of Downstream User (DU)
PART B. What should DUs do now?
B.1. Pre-registration / Registration
B.2. Communication on safe use up and down in the supply chain

PART C. Challenges faced by DUs
PART D. Summary

22

PART D. What should DUs do now
In summary
Understand your roles and responsibilities under REACH
ÂX Talk to your suppliers to ensure pre-registration andregistration of your substances→ Define business critical substances and assess options in case supplier is not
responsive or decides not to registerÂY Pre-register substances which are intentionally released
from articles
ÂZ If you are also manufacturer or importer, pre-register your substancesÂ[ If you own data, determine if you want to participate in SIEF
as data holder
Â\] Get prepared for communication up and down the supply chain (butwait for standardised IT-tools and questionnaires currently being
developed to communicate)Â^ Read, understand and work via your Trade Association wherever
appropriate
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Let’s work together !

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BACK-UPs
What should DUs do at a later stage?

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DU will also have to do …but at a later stage
Timing

Duty

Action requiredRef.

As per June 1, 2007
(in practice: from 1 June
2008, but in most casesin 2009-2010)

Must do-> comply with risk management measures (RMM) and with any restrictions which
are applicable to your use communicated in SDS-> if RMM of your use are not appropriate , communicate it to your supplier-> if your use is not covered , either report it to your supplier or perform your own
CSR and notify ECHA *Timing: Should be performed within 1 year of receiving SDS except
for notification to ECHA which needs to performed within 6 months-> Be aware that your supplier can refuse your use…

Guidance for
DU (chapter 5)

As per June 1, 2007

Must doif you have new information on the hazard of the substance, communicate it to yoursupplier

Guidance for
DU (chapter 10)

As per June 1, 2007
(in practice: from 1 June
2008, but in most casesin 2009-2010)

Must do

Provide your customers with SDS and potentially exposure scenario, if needed

Guidance for
DU

As per June 1, 2007 (inmost cases later on)

Must doIf no SDS is provided, comply with information provided by the supplier related toRMM, Authorization and Restriction (Art 32)

Guidance for
DU

As per June 1, 08

Must doReport to the Chemical Agency if your classification of substance is different to that ofyour supplier

Guidance for
DU

As per Jan 1, 2009

May doif you have information on substances e.g. test data, you may want to share themwithin SIEF as data holder

Guidance on
Data sharing

As per Jan 1, 2009

May doIf your substance that you use is not on the Pre-registration list published by ECHA,
you can ask ECHA to publish the name of your substance on its website. This could
help you to find a potential registrant for the substance.

Guidance for
DU (Chapter3.3)

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DU will also have to do …but at a later stage
Timing

Duty

Action requiredRef.

As per whencandidate list ofSVHC will be
published (end2008)

Must doIf you manuf. or import an article which contains SVHC from thecandidate list of SVHC at >0.1% (w/w), provide information to enablesafe use of your article to your customers and if requested to yourconsumers and in this last case you need to reply within 45 days ofrequest

Guidance on
articlesAs per June 1,2009

Must doAuthorisationa) Check if your substance is part of substances recommended to be
included in Annex XIV. If so, contact your supplierb) if the use of your substance is not covered by your supplier ‘sAuthorisation, and you want to continue this use, you will have toapply for an authorisation for your own use and potentially yourcustomer’s usea) Guidance
for DU(chapter 12)+ Guidanceonauthorisation(RIP 3.7)

Must doComply with Restriction, if relevant to your substance

By Dec 2010, June2013 or June 2018

Must doRegister subst. intentionally released from your articles
at >1t/y, or >100 t/y or > 1000 t/y if not already registered bysomebody in the same or different supply chain for that use

Guidance on
articlesAs per June 1,
2011

Must doIf you manuf./import an article containing a SVHC from the candidate
list of SVHC at >0.1% (w/w) and which is >1t/y and which has notbeen registered for that use, you need to submit a notification toECHA

Guidance on
articlesAs per June 1,
2009

Guidance forDU (chapter13)27Legend of symbols
Substance
Preparation containing several substances

Article containing a substance

Article containing a substance intended to be released

Annex:ESAnnex:ESSDS
SDS

Safety Data Sheet, with exposure scenarios annexed to it
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