Ref. Ares(2014)78299 - 15/01/2014‘ From pre-registration to joint submission’
Hendrik Abma
Director General
European Association of Chemical Distributors (FECC)

Commission REACH Workshop
14 April 2008

AGENDA FECC Pre-registration - Pre-SIEF - SIEF
 Data and cost sharing
 Joint submission
Please note that the screenshot has been kindly provided by the
ECHA/Commission for educational purposes.
The final version of REACH IT may present changes

FECC MEMBERSHIP
National Associations 17(including Switzerland and Norway)

FECC MEMBERSHIP
Company Members 31
ALGOL CHEMICALS OY

AVANTEC S.A.
AZELIS S.A.
BANG & BONSOMER GROUP
BIESTERFELD A.G.
BRENNTAG HOLDING GmbH & Co
BTC Europe
CALDIC BVCAMPI Y JOVE S.A.
C.H. ERBSLÖH K.G.
DIPOL Chemical International Inc.
EIGENMANN & VERONELLI S.p.A.
GROLMAN GROUPHARKE GROUP
Aug. HEDINGER GmbH & Co

HSH GROUPIMCD GROUP B.V.
KRAHN CHEMIE GmbHNORDMANN RASSMANN GmbH & Co
OMYA AG
ORKA d.o.o.
PENTA CHEMIKALIEN GmbH & Co KG
QUIMIDROGA S.A.
QUIMITECNICA.COM S.A.
R2 GROUP A/SSAFECHEM EUROPE GmbHTENNANTS DISTRIBUTION Ltd.
TER HELL groupUNIVAR Europe Ltd
WARWICK INTERNATIONAL GROUP LTD.
WELDING

Associate Members 12

LATEST FECC ACTIVITIES ON REACH
Observer seat at REACH CARound table on pre-registration, March 2008

Presentation to the ECHA, Feb. 2007



Testing of the Navigator and REACH IT

Participation in Commission REACH workshops

REACH Implementation Projects (RIPs): 3.1: Registration and Overall Guidance
 3.2: Chemical Safety Assessment and Report 3.4: Data and cost sharing
 3.5: Downstream users obligations
 3.6: GHS

REACHREACH will affect the entire supply chain and willmake the chemical distributors play a crucial role
MANUFACTURERS/ IMPORTERS

Properties ofsubstances andsafe uses

DISTRIBUTORSDOWNSTREAM
USERS

Information onuses of substances

REACH & CHEMICAL DISTRIBUTORS
Chemical Distributors may have different roles inREACH…
 Importer/Manufacturer: import into the EU (ormanufacture) a substance or a substance in a
preparation in 1 or more tonnes/yearDistributor: only stores and places on themarket a substance, on its own or in a
preparation, for third parties

Downstream user: uses a substance, either onits own or in a preparation, in the course of his
industrial or professional activities, e.g.
formulation, dilution, re-packaging, etc

REACH & CHEMICAL DISTRIBUTORS

Different roles for the same company
1) Buy Substance Y from EU supplier1) Import Substance X from non-EU supplier

IMPORTER X
2) Repackage Substances X + Y

DOWNSTREAM USER X+Y
3) Distribute Substances X + Y in the EU

DISTRIBUTOR X+Y

PRE-SIEF AND SIEF FORMATION
When a company pre-registers for the first time asubstance, a pre-SIEF page is created.
Subsequent pre-registrants of the same substancewill be added to this page.
Potential registrants:•••

Manufacturers and importers
Third party Representatives
Only Representatives

Other participants:••

Data holders(Downstream users and others) - Voluntary
Early registrants - MandatoryPRE-SIEF AND SIEF FORMATIONOVERVIEW PROCESSPre-SIEF discussions on sameness ofsubstanceRIP 3.10

Agreement on same substance
SIEF Formation
SIEF obligations applyData sharing
or Opt-out
Joint submission

SIEF FORMATION

Recommendation:
Issues to consider during first discussions:Confidentiality
 Scope of the cooperation
 Who will be the lead registrant?
 Agreement on joint submission and cost sharing Will the SIEF facilitator/Lead Registrant becompensated Legitimate possession
 Competition law rules apply! REACH should be
without prejudice to the full and complete applicationof the Community competition rules.

DATA SHARING: Issues to consider

Mandatory sharing of animal testing

Sharing of other tests upon request

Minimise costs in industry

The word ‘consortium’ is not mentioned inREACH

Guidelines are explicitly mentioned in REACH

RIP 3.4: Guidelines developed by
CEFIC, AISE, Eurometaux and FECCDATA SHARING

Two different mechanisms for phase-in
and non-phase-in substances:
Phase-in:

Pre-SIEF

Preregistration

Substance
identity

SIEF

Jointsubmission

Data sharing

Jointsubmission(RIP 3.10)

Non-phase-in:
Inquiry

Contact
previousregistrants

DATA SHARING

Phase-in:Identification of available information (internally)
Agreement on cooperation and cost sharing
Sharing of available information
Identification of information gaps
Search for needed information / New study
Data and Cost sharing
Joint submission

COST SHARING

Guidelines on cost sharing: affordable forSMEs!
REACH says that SIEF participants shall make every
effort to share costs in a fair, transparent and nondiscriminatory way (article 30)••••

According to volume (applicable to alltonnage bands)
Principles also apply to new studies
Freedom of choice: Historic vs replacement
Mark-up factors supported by documentation

COST SHARING

Guidelines on cost sharing: affordable forSMEs!
••••

Possibility of reduction factors
Risk premium only in some circumstances
Only payment for data needed for registration
Only one study per endpoint will becompensated• Payment at moment of registration• Value for risk premium and administrative
costs
Recommendation: be aware of the guidelines
for discussions on cost sharing

JOINT SUBMISSIONOne Substance One Submission



Opt-out:• Disproportionately costly• Confidential information at stake• Disagreement with lead registrantImplications:• Higher registration fees
• Dossier evaluation

JOINT SUBMISSION
 The Lead Registrant ‘opens’ the joint submission


Other members of the joint submission submit
registration dossier referring to lead registrant
submission for dataEach company receives a submission number anda reference number (official registration number):Type submission-unique number-check code- joint submission participant

Example format:

01-2114085-66-0000
01-..............-....-0001

JOINT SUBMISSION
Joint
submission

Separatesubmission

Optional

Classification&Labelling Identity of registrant

Guidance on safe use

Study summaries(Annexes VII to XI)

Identity of substanceChemical Safety Report(if required)

Robust studysummaries

Info on manufactureand use(s) ofsubstance

Proposals for testing

Exposure information if1-10 t/yOptionalIndication as to which
info has been reviewed

Indication as to which
info has been reviewed

Thank you very much for your attention
Questions?
www.fecc.org