The role of the only representative

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The role of the only representative

• Simona Fajfar

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Only representative (OR)

• Only representative means a natural or legal
  person established in the EU and appointed by a
  manufacturer, formulator or producer of an
  article established outside the EU to fulfil the
  obligatioins of importers (Article 8).

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OR registration obligation

• Only representative established in the EU and
  appointed by a manufacturer, formulator or
  article producer established outside the EU to
  fulfill the registration obligation of importers

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Why to have an only representative?

• If you wish to export from Serbia or other
  non-EU country to EU and be on the market
• You have two options
• Put on EU market through Importers only
• Appointment of Only representative

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When you have appointed OR

• This will relieve the EU importers within the
  same supply chain from their registration
  obligation, as they will be regarded as a down
  stream users.

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Importer

• Importer means any natural or legal person
  established within the EU who is responsible for
  import (Article 3(11)).
• Import means the physical introduction into the
  customs territory of the EU (Article 3(10)).

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Example

• Import of mixture (glu) formulated in Sebia
• A company x (downstream user-article producer) is
  needing a components for their products
• He has to decide ether to buy it from EU supplier
  or become an importer for this specific mixture

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Indentification of the role

• Legal entities can have more than one role
• Important to identify different roles
• You can be OR and downstream user for another
  substance which you are buying on a EU market
• Situation in Slovenia when roles are changing (it
  is all about costs)

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Possible tasks of the OR

• OR is the one who is legaly responsible in the
  REACH system
• Non-EU manufacturer is not legally responsible
• Obligation as a registrant to register
• substances as such in a mixture or in article

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Obligations of the OR regarding the registration
of substances

• An OR is fully responsible and liable for
  fulfilling all obligations of importrs for the
  substances he is responsible for.
• To have in mind that OR has also other
  obligations of the importers under REACH.

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Obligation of the OR

• Pre-registration
• Data sharing
• Involment in the SIEF (Substance Information
  Exchange Forum)
• Can play an active role within SIEF. Can be
  involved in SIEF negotiations.

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Taking care of imported quatities

• The OR registers the imported quantities
  depending on the contactual arrangements between
  the non EU manufacturer and OR.

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Obligation of OR

• OR shall keep an up to date list of EU customers
  (importers) within the same supply chain of the
  non-EU manufacturer and the tonnage covered for
  each of this customers, as well as information on
  the supply of the latest update of the Safety
  Data Sheet.

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OR should proof to enforcement Authorities

• It is essential that there is clear
  identification of
• Who in the supply chain of a substance outside EU
  is the manufacturer, formulator or producer of
  articles.
• Who has appointed the OR
• Which imports the OR has responsibility for

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Who can appoint an OR?

• According to Article 8(1) a non-EU manufacurer
  being a natural of a legal person who is
  manufacturing a substance, formulating a mixture
  or producing an article that is imported into the
  EU can appoint an OR to fulfil the registration
  obligaton for importers.
• Non- EU distributors are not mentioned in this
  article and therefore can not appoint OR

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Who can not appoint an OR

• It should be noted that a non-EU distributor is
  not a distributor for the purposes of REACH as he
  is not a natural or legal person established in
  the EU.
• An EU based distributor cannot appoint an OR.

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How to choose the right OR

• Someone you can have a good businees relation
  ship
• Enough of experience Knowing the legislation,
  also legal and economic knowledge
• It might me a team who knows what are they are
  doing
• Easy to communicate with

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Contract beetwen non-EU manufacturer and OR

• A clause what happen when your status change and
  Serbia is becoming part of EU
• Who is the owner of registration?

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How to change the OR?

• The change should be easy to do
• Written in a contract between OR and non-EU
  manufacturer
• You need a good lawyer to have a good contact
• The reality of REACH is that many things are
  legal (good legal advise in needed and a other
  skills)

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If you decide to change the OR?

• If a non EU manufacturer decides to change his
  OR, the succesor will have to update the
  information related to the legal entity provided
  to ECHA.It is recommended that the new only
  representative submit evidence of his appointment
  and of agreement of the earlier OR to this
  change.This to include in as a clause of the
  contact.

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How to avoide possible problems in practice

• When we can expect problems in practice
• with OR?
• Contact
• Enough experience from the side of OR
• Also OR can have problems
• It is also about good business relationship
• It is about partnership /they both loose

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Obligation to communicate down the supply chain

• Same obligation as an importer
• Article 33 obligation to communicate about the
  substance on the candidate list
• Information if substance is subject to an
  authorisation
• Information about substances which fall under
  restriction
• Providing Safety Data Sheet

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REACH certificate

• According to legislation there is no REACH
  certificate
• But in practice they are
• Companies they find the way how to proof that
  their product is in compliance with REACH.

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SIEF
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SIEF formation

• All potential registrants and data holders for
  the same pre-registered phase in substance are
  participants in Substance information Exchange
  Forum (SIEF).
• Aims of the SIEF
• To facilitate data sharing for the purposes of
  registration
• Agree on classification and labelling where there
  is difference beetwen potential registrants

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Example 1
100 legal entities which has pre-registered a
substance in 2008
0 registration in 2010
31st May 2013
50 registration 2018
50 registration 2013
DORMANT NOW
ACTION NOW
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Example 2
TOKEN CODE !!!
100 legal entities which has pre-registered a
substance in 2008
10 registrations 2010
31st May 2013
50 registration 2018
40 registrations 2013
Letter of Access to the data
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Example 3
100 legal entities which has pre-registered a
substance in 2008
31st May 2018
0 registrations in 2010
100 registrations 2018
0 registrations 2013
ACTION STARTS IN 2016
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REGISTRATION at ECHA
Joint Registration - LR (LEAD REGISTRANT)
Token code
S I E F
Only Lead COMPANY
Pridobitev manjkajocih podatkov
1. INCLUSION INTO CONSORITUM AS ASSOCIATED
MEMBER 2. Complete LoA 3. Partial LoA

Individual registrant
CONSORTIUM
Lead Company
Individual registrant
Members of CONSORTIUM
PRE-REGISTRATION ECHA
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• In case several companies established outside the
  EU are part of the same group, and those
  companies export the same substance into the EU,
  each company consistutes a non EU manufacturer
  under REACH and may appoint an OR. The OR will
  have to submit separate registrations for each of
  the companies he is representing.

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• HVALA