REACH Industry Update

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REACH Industry Update
WERCS US User Group Meeting 2008
Dr. Erwin Annys Sr. Advisor Product Innovation
Policy
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REACH

• Registration
• Evaluation
• Authorisation and restriction
• of
• Chemical substances

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REACH
Agency
Responsibility industry
Sharing data
Restriction
Down stream use
Authorisation
Info in supply chain
Classification index
Registration

• Evaluation

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Registration
Pre-registration
gt 1 ton
gt100 ton
gt1000 ton CMR gt1 ton N, R50-53 gt 100 ton
0 1 2 3 4 5
6 7 8 9 10 11
Non phase-in substances
01/06/08
01/12/08
01/06/18
01/06/07
01/12/10
01/06/13
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Possibilities for pre-registration
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Note

• About the screenshots shown
• Text and help text is not finalised yet
• Look and feel is not finalised yet

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Pre-registering on-line using REACH-IT

• before pre-registering
• you need to have created an account in REACH-IT
  for your company
• you need to be logged in
• you need to have the information on the substance
  you want to pre-register at hand
• select pre-register a phase-in substance in the
  functional menu

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Pre-registering on-line using REACH-IT

• steps (are implemented as different tabs)
• identification mandatory
• similar substances optional
• tonnage mandatory
• contact optional
• representative optional
• remarks optional
• validation mandatory
• typically takes 2 40 minutes to go through all
  steps

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REACH Only Representative
WERCS User Group Meeting 2008
Dr. Erwin Annys Sr. Advisor Product Innovation
Policy
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The most simple situation
outside EU
inside EU
EU DU 1
Substance A
M1
Importer
EU DU 2
EU DU 3
The importer registers the substance A
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Import from different suppliers
outside EU
inside EU
EU DU 1
Substance A
M1
Importer
EU DU 2
Substance A
EU DU 3
M2
The importer registers the substance A for the
combined tonnages
M3
Substance A
I keeps control and can import from every other M
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Import by different importers
outside EU
inside EU
EU DU 1
Substance A
M
Importer 1
EU DU 2
EU DU 3
Substance A
Importer 2
Both importers have to register according to
their tonnage
No registration costs for M but every new EU
client has to do a registration
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Import from a formulator
outside EU
inside EU
Substance A
M1
EU DU 1
Importer
EU DU 2
F
Substance B
EU DU 3
M2
The importer registers the substances A, B and C
for their tonnage in the formulation
M3
Substance C
I needs to know the composition before he can
register!
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Solution

• The only representative (OR)
• Article 8 Only representative of a non-Community
  manufacturer
• 1. A natural or legal person established outside
  the Community who manufactures a substance on its
  own, in preparations or in articles, formulates a
  preparation or produces an article that is
  imported into the Community may by mutual
  agreement appoint a natural or legal person
  established in the Community to fulfil, as his
  only representative, the obligations on importers
  under this Title.

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Solution

• 2. The representative shall also comply with all
  other obligations of importers under this
  Regulation. To this end, he shall have a
  sufficient background in the practical handling
  of substances and the information related to them
  and, without prejudice to Article 36, shall keep
  available and up-to-date information on
  quantities imported and customers sold to, as
  well as information on the supply of the latest
  update of the safety data sheet referred to in
  Article 31.
• 3. If a representative is appointed in accordance
  with paragraphs 1 and 2, the non-Community
  manufacturer shall inform the importer(s) within
  the same supply chain of the appointment. These
  importers shall be regarded as downstream users
  for the purposes of this Regulation.

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Only Representative
outside EU
inside EU
EU DU 1
M
(Importer) DU 1
EU DU 2
(Importer) DU 2
EU DU 3
OR
OR OR takes over the registration obligation
from the importer who becomes a DU
Costs are for M, but with one registration he can
cover the whole EU market I/DU is dependent from
the M and cant buy from another unless this is
covered by another registration
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Import from a formulator
outside EU
inside EU
Substance A
M1
EU DU 1
(Importer) DU
EU DU 2
F
Substance B
EU DU 3
M2
OR
M3
Substance C
The OR registers the substances A, B and C for
their tonnage in the formulation
I becomes DU and doesnt have to register so he
doesnt need to know the exact composition
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Import from different suppliers
outside EU
inside EU
OR1
EU DU 1
Substance A
M1
(Importer) DU
EU DU 2
Substance A
EU DU 3
OR2
M2
M3
OR3
Substance A
Each OR registers substance A for the tonnage of
its M
I can not buy A from M4 unless this is covered by
a registration
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Import from different suppliers
outside EU
inside EU
OR
EU DU 1
Substance A
M1
(Importer) DU
EU DU 2
Substance A
EU DU 3
M2
OR can represent more than one M but he has to do
a registration for each of them according to
their tonnage and pay a fee for each of them
M3
Substance A
I can not buy A from M4 unless this is covered by
a registration
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Example from the guidance
Outside EU
inside EU

• Role and Registration Obligations
• Importer 1
• Registers 3 tonnes
• is a DU of the OR for the remaining 5 tonnes
• OR
• Registers the tonnage exported by the not-EU
  manufacturer 2 and 3, i.e. 16 tonnes of
  substances
• The registration dossier should be made for
  10-100 tonnes, including a CSR.
• - OR does two registrations, each for 1 10
  tonnes
• Importer 2
• Does not need to register
• Is a DU of the OR
• Importer 3
• Does not neetd to register
• Is a DU of the OR

Non-EU Manufacturer 1
3 tonnes
Non-EU Manufacturer 2
Importer 1
5 tonnes
DU of
Appoint as OR
Only Representative
Appoint as OR
DU of
3 tonnes
DU of
Importer 2
Non-EU Manufacturer 3
5 tonnes
3 tonnes
Non-EU Distributor
Importer 3
3 tonnes
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Dont forget the timing
Pre-registration
gt 1 ton
gt100 ton
gt1000 ton CMR gt1 ton N, R50-53 gt 100 ton
0 1 2 3 4 5
6 7 8 9 10 11
Non phase-in substances
01/06/08
01/12/08
01/06/18
01/06/07
01/12/10
01/06/13
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What to register?
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REACH The review of Annexes IV and V
WERCS User Group Meeting 2008
Dr. Erwin Annys Sr. Advisor Product Innovation
Policy
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Review of Annex IV
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Surprise
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Annex IV

• Noble gases
• The addition of the following substances from
  Annex V
• Helium He
• Neon Ne
• Xenon Xe
• The addition of another noble gas
• Krypton Kr
• The Commission services are of the opinion that
  the noble gases fulfil the criteria for inclusion
  into Annex IV. Moreover, the existing annex
  already included one noble gas (Argon) and Annex
  V included 3 other noble gases (Helium, Neon,
  Xenon). For consistency reasons, it therefore
  seems appropriate to re-group all noble gases in
  Annex IV and to delete the corresponding entries
  in Annex V.

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Annex IV

• (2) Sugars
• The addition of the following sugars that the
  Commission has accepted are of minimum risk
• Fructose
• Galactose
• Lactose
• The Commission services consider that these three
  substances fulfil the criteria for inclusion into
  Annex IV.

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Annex IV

• (3) Carbon and graphite
• The deletion of the following substances based on
  the analysis of the contractor
• Graphite
• Carbon
• The concerned EINECS entries have in the past
  been used to identify nanoforms of carbon or
  graphite. For these nanoforms insufficient
  information is available to conclude that they
  present minimum risk because of their intrinsic
  properties. As Annex IV does not distinguish
  between different forms of one substance, carbon
  and graphite should be deleted and registration
  should be required for these substances.

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Annex IV

• (5) Oils, fats, waxes, fatty acids and their
  salts
• The deletion of all the current vegetable oils
  entries, as the Commission is proposing a generic
  entry in Annex V to cover all vegetable oils
• The deletion of the all the current fatty acids
  entries, as the Commission is proposing a generic
  entry in Annex V to cover a number of these
  substances

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Annex IV

• (4) Vitamin A
• The deletion of the following substance based on
  the analysis of the contractor
• Vitamin A
• Deletion is proposed because Vitamin A may
  exhibit significant risks on the basis of its
  intrinsic properties (e.g. reproductive toxicity).

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Annex V

• 1. Substances which result from a chemical
  reaction that occurs incidental to exposure of
  another substance or article to environmental
  factors such as air, moisture, microbial
  organisms or sunlight.
• 2. Substances which result from a chemical
  reaction that occurs incidental to storage of
  another substance, preparation or article.
• 3. Substances which result from a chemical
  reaction occurring upon end use of other
  substances, preparations or articles and which
  are not themselves manufactured, imported or
  placed on the market.

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Proposal new guidance

• Examples of substances covered by this entry are
  the products produced from the use of adhesives
  and paints, combustion products of petrol during
  the use of cars, and the reaction products of
  bleaching agents during washing of textiles. This
  also covers substances present as ionic mixtures
  resulting from mixing salts, acids and bases.
  However, the toxicological and ecotoxicological
  properties of salts are determined by the
  properties of their acidic and alkaline
  constituents. In so far, registration would be
  inappropriate for substances produced in a
  solution through mixing acids, bases or salts,
  provided that all acids, bases and salts
  introduced into the mixture have already been
  registered by an actor up the supply chain and
  none of the produced substances is isolated from
  the mixture.

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Annex V

• 4. Substances which are not themselves
  manufactured, imported or placed on the market
  and which result from a chemical reaction that
  occurs when
• (a) a stabiliser, colorant, flavouring agent,
  antioxidant, filler, solvent, carrier,
  surfactant, plasticiser, corrosion inhibitor,
  antifoamer or defoamer, dispersant, precipitation
  inhibitor, desiccant, binder, emulsifier,
  de-emulsifier, dewatering agent, agglomerating
  agent, adhesion promoter, flow modifier, pH
  neutraliser, sequesterant, coagulant, flocculant,
  fire retardant, lubricant, chelating agent, or
  quality control reagent functions as intended
  or
• (b) a substance solely intended to provide a
  specific physicochemical characteristic
  functions as intended.

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Annex V

• 5. By-products, unless they are imported or
  placed on the market themselves
• 6. Hydrates of a substance or hydrated ions,
  formed by association of a substance with water,
  provided that the substance has been registered
  by the manufacturer or importer using this
  exemption.
• 7. The following substances which occur in
  nature, if they are not chemically modified
• Minerals, ores, ore concentrates, raw and
  processed natural gas, crude oil, coal.
• 8. Substances which occur in nature other than
  those listed under paragraph 7, if they are not
  chemically modified, unless they meet the
  criteria for classification as dangerous
  according to Directive 67/548/EEC or PBT, vPvB or
  equivalent concern

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Annex V

• 9. The following substances obtained from natural
  sources, if they are not chemically modified,
  unless they meet the criteria for classification
  as dangerous according to Directive 67/548/EEC or
  PB, vPvB or equivalent concern, with the
  exception of those only classified as flammable
  R10, as a skin irritant R38 or as an eye
  irritant R36
• Vegetable fats, vegetable oils, vegetable waxes
  animal fats, animal oils, animal waxes fatty
  acids from C6 to C24 and their potassium, sodium,
  calcium and magnesium salts.
• Glycerol
• 10.The following substances if they are not
  chemically modified
• Liquefied petroleum gas, natural gas condensate,
  process gases and components thereof, coke,
  cement clinker, magnesia.

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Annex V

• 11. The following substances unless they meet
  the criteria for classification as dangerous
  according to Directive 67/548/EEC or PBT,vPvB or
  equivalent concern and provided that they do not
  contain constituents meeting the criteria as
  dangerous in accordance with Directive 67/548/EEC
  present in concentrations above the lowest of the
  applicable concentration limits set out in
  Directive 1999/45/EC or concentration limit set
  out in Annex I to Directive 67/548/EEC, unless
  conclusive scientific experimental data show that
  these constituents are not available throughout
  the life-cycle of the substance and those data
  have been ascertained to be adequate and
  reliable
• Glass, ceramic frits

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Annex V

• 12. Compost, biogas
• 13. Hydrogen and oxygen.

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Thanks for your attention