REACH: substances in articles RIP 3'8

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REACH substances in articles (RIP 3.8)
Dr. Erwin Annys Sr. Advisor Product Innovation
Policy WERCS 2007 EU User group Napoli 31/05/07
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Definitions

• Substance
• A chemical element and its compounds in the
  natural state or obtained by any manufacturing
  process
• Including
• Any additive necessary to preserve its stability
• Any impurity deriving from the process used
• Excluding
• Any solvent which may be separated without
  affecting the stability of the substance or
  changing its composition

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Definitions

• Preparation" a mixture or solution composed of
  two or more substances
• Article" an object which during production is
  given a special shape, surface or design which
  determines its function to a greater degree than
  does its chemical composition
• With substances intended to be released under
  normal or reasonably foreseeable conditions of
  use
• With substances not intended to be released under
  normal or reasonably foreseeable conditions of
  use

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Definitions

• Any producer or importer of articles shall submit
  a registration to the Agency for any substance
  contained in those articles, if both the
  following conditions are met
• (a) the substance is present in those articles in
  quantities totalling over 1 tonne per producer or
  importer per year
• (b) the substance is intended to be released
  under normal or reasonably foreseeable conditions
  of use.

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Definitions

• Any producer or importer of articles shall notify
  the Agency, in accordance with paragraph 4 of
  this Article, if a substance meets the criteria
  in Article 57 and is identified in accordance
  with Article 59(1), if both the following
  conditions are met
• (a) the substance is present in those articles in
  quantities totalling over 1 tonne per producer or
  importer per year
• (b) the substance is present in those articles
  above a concentration of 0,1 weight by weight
  (w/w)

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Examples
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Examples
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Examples
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Examples
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Examples
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Examples
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Examples
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REACH definitions

• Producer of an article any natural or legal
  person who makes or assembles an article within
  the Community
• Manufacturer any natural or legal person
  established within the Community who manufactures
  a substance within the Community
• Importer any natural or legal person
  established within the Community who is
  responsible for import

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REACH definitions

• Downstream user any natural or legal person
  established within the Community, other than the
  manufacturer or the importer, who uses a
  substance, either on its own or in a preparation,
  in the course of his industrial or professional
  activities. A distributor or a consumer is not a
  downstream user.
• Distributor any natural or legal person
  established within the Community, including a
  retailer, who only stores and places on the
  market a substance, on its own or in a
  preparation, for third parties

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REACH definitions

• REACH has the following consequences
• Substances
• Preparations
• Articles
• With substances intended to be released
• With substances not intended to be released

Registration
Registration
Notification (SVHC)
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REACH definitions

• You buy
• Substances outside the EU?
• Preparations outside the EU?
• Articles outside the EU?
• Polymers outside the EU?

You have to register
Difficult, you have to register the substances in
the preparation
Take care for eventual registration or
notification
You register the monomers and bounded additives
gt2
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Purchase substances outside EU

• Exactly the same as producing it in EU
• You have the same responsibilities as a EU
  producer
• Unless you buy via an agent or distributor
• Unless the non EU producer appoints an only
  representative

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REACH and distribution
Distributeur
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Purchase preparations outside EU

• For preparations you buy outside the EU, you are
  the importer of all substances that are present
  in the preparation, otherwise said you have to do
  the necesarry to register  
• The Safety Data Sheet is not giving you the
  complete composition!?

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Purchase polymers outside EU

• You are responsible for the registration of
  monomers and the chemically bounded additives
• Above 2 (not as free monomer, but incorporated
  in the chain)
• Above 1 ton per year
• Not registered yet by an actor up the supply
  chain

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Purchase articles outside EU

• Distinction
• Intended release
• Registration
• gt 1 ton per year
• Not intended release
• Notification
• Substances falling under authorisation
• gt 1 ton per year
• gt 0,1

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Purchase articles outside EU

• Comparable treatment
• But no control higher in the supply chain
• REACH is European
• Enforcement?

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Thanks for your attention