Source: http://www.docstoc.com/docs/95839132/PowerPoint-Presentation---FEC
Timestamp: 2015-07-29 18:54:43
Document Index: 93940480

Matched Legal Cases: ['Art. 28', 'Art. 37', 'Art. 37', 'Art. 3', 'Art. 7', 'Art. 7', 'Art.57', 'Art.59', 'Art. 7', 'Art. 7', 'Art. 7', 'Art. 7', 'Art. 57', 'Art. 6', 'Art. 28', 'Art.8', 'Art.8', 'Art. 2', 'Art. 56', 'Art. 28', 'Art. 58', 'Art. 37', 'Art. 58', 'Art. 6', 'Art. 57', 'Art. 37', 'Art. 38', 'Art. 37', 'Art. 7', 'Art. 66', 'Art. 56', 'Art. 7', 'Art. 56', 'Art. 57', 'Art. 7', 'Art. 66', 'Art. 7']

PowerPoint Presentation - FEC by wuxiangyu
95839132
How Downstream Users REACH?
Impacts and challenges of REACH
for EU Cutlery, Flatware, Holloware, and Cookware Industries
FEC General Assembly
Fran&#231;oise Duplat
Orgalime secretariat
• 35 Member Associations
• 23 European Countries
• 130 000 Companies
FI           • €1779 Bn output 2006 (EU-27
estimates for the whole
engineering industry)
• 10.6 Mio employment
IE   UK
CZ                        AT
SL        HR
PT   ES                             IT                                     BG
 REACH priorities for DU
 Communication in the supply chain
 Substances in articles
 Authorisation procedures
Why &#171; REACH &#187;?
 REACH: &#171; Registration Evaluation Authorisation of Chemicals &#187;
 Before REACH – various legislation relating to chemicals :
 Directive 67/548/EEC, Directive 1999/45/EC, Regulation (ECC) n&#176; 793/93,
Directive 76/769/EEC etc
 BUT lack of harmonisation between so-called &#171;new&#187; and
&#171; existing&#187; substances
 Therefore elaboration of &#171; REACH Regulation &#187;
   Publication of the COM Proposal on REACH: 29 Oct. 2003
   Negociation European Parliament and Council: end of 2003-Dec. 2006
   European Regulation n&#176; 1907/2006 adopted 18 Dec. 2006
   Publication in EU Official Journal : 30 Dec. 2006
 Creation of European Chemicals Agency (ECHA)
REACH Regulation n&#176;1907/2006
   Entered into force on 1st June 2007
   Directly applicable and full harmonisation except enforcement
   Strengthened industry responsibility to provide and communicate
safety information on substances and to properly manage the risk
realted to their use.
   Scope: All substances, on their own, in preparations, in articles
   Exemption to scope: radioactive, non-isolated intermediates, waste, transport, transit or
reexportation, interest of defence
   Further exemptions to some parts of REACH, e.g. for R&amp;D, acc. to use, nature of substance etc
   All EU actors of supply chain concerned: from e.g. EU
manufacturer/importer (M/I) of substances to downstream users
(DU)/article producer or article importer
   REACH obligations according to role in supply chain
What focus for Orgalime?
Substance                             Formulator of                                substances/
manufacturer/                          preparations                                 preparations
importer                       (“1st level downstream users”)                   (“2d level downstream users”)
e.g. chemical industry               e.g. paint manufacturer                        Orgalime Industries
Orgalime practical guide for downstream users, article                                      Article producers/
producers and article importers to understanding Regulation                                 Article importers
N&#176;1907/2006 on REACH (May 2007)                                                            Orgalime Industries
Available free of charge at www.publications.orgalime.org
 Structure:
 Introduction (definitions, acronyms etc.)
 Overview important dates and deadlines
 Orgalime quick screens
 More detailed guidelines on selected issues
 One page summary on timelines and obligations
REACH priorities
Check Orgalime
for Orgalime industries                                                  1,2,3,4
In the context of registration of substance:
Title V (mainly)
Registration of substances intentionally released
from articles under certain conditions
Notification of substances of very high concern
present in articles under certain conditions
Communication requirements on substances of very
high concern present in articles under certain
Use of authorised substances/application for
authorisation for substances included in Annex XIV
Guidelines 1,2,3,4
What is my role in the               Downstream user means….
supply chain?                     “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 (…)
 Downstream user?
Establish inventories
 Importer?                                                           Article producer
(&#171; only representative&#187;                                               means….
nominated in the EU?)       according to role                         “means any natural or legal person who
makes or assembles an article within the
producer/importer?       Takes time and
A company may play
scope/exemptions
several roles!
   Registration of substances on their own or in preparations, intentionally
released from articles ≥ 1 t/y per M/I
 For “non phase-in substances” ≥ 1 t/y: as of 1/06/2008, before
manufacturing/importing/putting on the market
 For “phase-in” substances ≥ 1 t/y: transitional regime
 ≥1000 t/y, CMR ≥1 t/y, aqu.tox. ≥100 t/y : 30 /11/2010
 100 - 1000 t/y: 31/05/2013
 1- 100 t/y : 31/05/2018
 To benefit from transitional regime: PRE-REGISTRATION required!
 “No data - no market”
 DU to communicate uses to allow manufacturer/importer (i.e.
supplier) to complete registration dossier
the supply chain (1)                                                        guideline 5
ESSENTIAL to ensure that substances used will
be pre-registered/registered by supplier
   Pre-registration : between 1/06/2008 and 1/12/2008 (Art. 28)
   DU not considered as potential registrant
   List of pre-registered substances on the ECHA website by 1/1/2009
   Notification to Agency of interest for a non pre-registered substances
   DU may be part to Substance Information Exchange Forum (SIEF)
&#171; No data - No market &#187;
Possible consequences on continuity of supply
the supply chain (2)                                                       guideline 5
 Supplier (M/I) to compile registration dossier
 Technical dossier: starting at 1 t/y
 Chemical safety report (CSR): starting at 10 t/y
 CSR to include exposure scenario (ES) if substance is dangerous,
 ES to cover manufacture of sub. and DU identified uses
 DU &#171;identified use&#187; covered ? DU has the right to make his use
known to supplier (&#171; brief description of use &#187;)
 DU to provide sufficient information to allow supplier to prepare
exposure scenario/use and exposure category (ES/UEC) for his use
 ES annexed to safety data sheet (SDS)
the supply chain (3)                                               guideline 5
    Possible uses advised against, but only for reasons of
protection of human health or the environment
   If no SDS but risks management measures (RMMs):
   DU to identify, apply and where suitable recommend
RMMs ( listed in SDS or Article 32)
   12 Months to comply with Art. 37 after receiving
registration number in SDS
   Further DU communication duties
Important to BE PRO-ACTIVE and inquire early enough
on supplier’s policy towards substance/preparation used
DU own chemical
safety report                                                                 guideline 6
 Specific cases : DU to perform own chemical safety
report (CSR) and report to ECHA (Art. 37.4, 38 and
Annex XII) for:
 Use outside conditions described ES/UEC of supplier
 Use advised against (protection of health and the environment)
 DU to identify, apply and where suitable recommend
RMMs of his own CSR
 Information to be kept available and up to date
 Exemptions foreseen!
Requires specific chemical knowledge
Make sure supplier’s ES covers DU uses
What is an &#171; article &#187;?
?                          Check
Guidelines 7,8,9
“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” (Art. 3.3)
E.g.: electrical and electronic equipment, a screw,
a bolt, a motor, cutlery, cookware, etc.
intentionally released from articles
?                        Check
Article producer,article importer/&#171;only representative&#187; to
REGISTER any substance in articles if
 Intentional release under normal or reasonably foreseeable
 Total amount of substance present in articles over 1 tonne per
producer/ importer per year (Art. 7.1)
Same timeline to register as for any other substances (2010-
2013-2018) - Registration fees
NO registration of substance in article if substance has
already been registered for that use (Art. 7.6)
Notification of substances                                                      Orgalime
Article producer,article importer/&#171;only representative&#187;
to NOTIFY substances in articles if the substance
 Has been identified as of very high concern (Art.57) i.e. CMR 1 &amp; 2, PBT/ vPvB
and any other substance of equivalent concern AND
 Is present in articles in quantities over 1 t/y AND
 Has been included in the candidate list (Art.59) AND
 Is present in the article above a concentration of 0.1% w/w (Art. 7.2)
FROM 1/06/2011, 6 months after inclusion in candidate list
Notification of substance in article NOT required
 If substance has already been registered for that use (Art. 7.6)
 If exposure to human health and the environment, including disposal, can be
excluded (appropriate instructions to recipient) (Art. 7.3)
 ECHA to possibly require registration for
substances present in articles under certain
conditions (Art. 7.5)
 Concentration calculation &#171; 0.1% w/w &#187; at the
level of the article
 Consequences on smooth running of supply
chain and just in time delivery of articles
on substances in articles                             ?                       Check
 Supplier of an article to provide sufficient information
available to him, as a minimum name of substance, to
recipient of article to allow safe use if the substance
 Is identified as of very high concern AND
 Is included in the candidate list for inclusion in Annex XIV AND
 Is present in the article in concentration above 0.1% w/w
 Extended to consumers upon request (within 45 days
procedure (1)                                                                        guideline 10
 Concerns substances of very high concern on their own/in
preparations/ incorporated in articles during process phase
 &#171; Progressive&#187; procedure:
   Sub. incorporated in the candidate list
   Priority list from ECHA no later than 01/06/09
   Further inclusion of sub. in Annex XIV
   Application for authorisation (by M/I/DU - analysis of alternatives - fees!)
   COM to decide on granting/reviewing authorisation
 NO tonnage threshold
 DU may use a substance listed in Annex XIV if authorisation granted
for that use up the supply chain
 Notification to ECHA within 3 months of first supply!
 Exemption certain uses and categories of uses
 Further exemptions foreseen!
 Two routes foreseen
procedure (2)                                                          guideline 10
 An authorisation for the use of a substance listed in Annex
XIV will be granted only if :
 Risks adequately controlled, OR
 Adequate control cannot be demonstrated but it is shown
that socio-economic benefits outweigh the risk to
human health or the environment arising from the use of
the substance and if there are no suitable alternative
substances or technologies.
of authorisation procedures
   Substance withdrawal from the market
   Disruption in the supply chain
   Technology changes
   Costly and time consuming procedures
(analysis of alternatives and where such alternative
exists – substitution plan)
DU to make sure that the substance used
is authorised for his use up the supply chain
Orgalime REACH guide                                4.1. Orgalime REACH Quick Screen 1
Registration of substances/substances in preparations
used in industrial (including engineering) processes
Make substance inventory:
Do you use substances/preparations
in your industrial processes?
See guideline 3
Are the substances/
substances in preparations
exempted from registration?
no      No further
4.2. Orgalime REACH Quick Screen 2
REACH authorisation procedures
Supply of substance in the EU
Make substance inventory: do you use substances
See guideline 2                                                                                          no        No further
•Only representative                                      •Only representative                               on their own/in preparations identified as substances of
will no longer be possible                                                      requirement
will act as importer                                      will act as importer                 (&#171; no data - no market &#187;):very high concern (Svhc)? (Art. 57)
and has to register                                            no
and has to apply for                 You may re-consider alternative
supplier outside the EU/notify the          yes
the substance (Art. 6)                                    Authorisation.
Does your non
•You are a                                                •Youyou import make
Do are DU: substancesyes            Does of your interest for that
Agencyyour non                          Do you import Svhc/
yes    EU supplier          yes
downstream user:                                          sure your use
/preparations                substance (Art. 28.4 and 28.5). preparations containing Svhc
EU supplier               yes
have an only
check whether                                                  be outside the EU?
willfromincluded in                  See guideline 5
have an only                          from outside the EU?
representative               the application for 4                 representative
your use will be                                                 See guideline                                                            See guideline 4
in the EU? (Art.8)             authorisation.                      in the EU? (Art.8)                       4.3. Orgalime REACH Quick Screen 3
See guideline 10
See guideline 5               no                               no                              no                 Registration of substances intentionally released from                                              articles
an alternative substance or your use generally yes
Is there an                                                                                              exempted from authorisation?            No further
yes      Will the supplier pre-register/     no there an supplier in the EU
alternative supplier                                                                                            (Art. 2, Art. 56.3 to 56.6)
register the substance/substances alternative supplierwill pre-register/
in the EU?                                                          in the EU?           register?                   no
in preparations? (Art. 28)
no                                                                  no                                                   Make uses
Is your use /category ofinventory of articles:
yes                                                                                                                                         No further
yes                                Do you produce in
specifically exempted from the EU articles that No further
•You act as importer of                                                •You act as importer of                                        intentionally release
authorisation? (Art. 58.2) substances or do you       requirement requirements
substance/preparation and may                                          substance/preparation.                                         import such articles from outside the EU?
Will the supplier cover your use         no                                                no
have to pre-register/register                                                                     Is for an
•You may have to applytherean alternative
in his registration file? (Art. 37)                                                                       yes                       Monitor Agency website
the substance on its own/                                                                       supplier who
authorisation and cannot benefitwill cover
yes                                        Is the substance                      no       and priority list (Art. 58.3)
in preparation (Art. 6)                                                from an authorisation granted to your use? included in the candidate list (liable
for possible inclusion of
•If Svhc: check Orgalime                              yes              an actor up the supply chain no
Make inventory of
for authorisation)? (Art. 57 and 59) substances substance in candidate list.
for that use.                                                   intentionally released from the article:                   No further
Quick Screen 2                                                                                                                      yes
See guideline 10                                                 Are they exempted from registration?                      requirements
•Identify, apply and where suitable recommend                    •Carry out your own chemical                           See
Is the substanceguidelines 2 and 3  no       Follow closely comitology
risk management measures communicated to you                    safety report (Art. 37.4, Annex XII) listed in annex XIV?                            procedure prior to inclusion
Check exemptions!                          yes                no                     of substance in Annex XIV.
in safety data sheet or in information communicated
to you in accordance with Article 32.                            •Report to the Agency (Art. 38).                                                               yes
Has in accordance
Do you use a substancethe substance in the article
•Identify, apply and where suitable                                                                       No further
See guideline 5                                                                                                                              yes      Notify the Agency within
recommend risk management                             been already registered
with the conditions of authorisation                                        requirements
•If substance of very high concern (Svhc):                                                                                                             3 months of first supply
measures (Art. 37.5).                                   for up
granted to an actorthat use? (Art. 7.6)
check Orgalime Quick Screen 2                                                                                                                                  (Art. 66.1).
See guideline 6                your supply chain? (Art. 56.2)
no                           See guideline 10
•If Svhc: check Orgalime                   no
Quick Screen 2                                                                                   no
Is the substance present yes
Has the sunset date been reached? in article You may no longer further       No use the
in quantity over 1 tonne per     substance unless the request
RECOMMENDATIONS:                                                                                                                          no producer/importer per year? (Art. 7.1)
for an authorisation
•Start your substance inventory NOW.                                         Apply for an authorisation             yes
Do you wish to keep your use                          has been made at least
•Start communicating with suppliers EARLY: to ensure continuous supply of aown use. be PRO-ACTIVE,
for your substance,                                       confidential?
18 months before the sunset
don’t wait until the supplier has registered the substance you are using See guideline 10 communicating!
in processes to start                                                                                  date and the decision
•Make sure the substance you use will be pre-registered. In case the substance you use has not been pre-                                  no Is the substance intended
no                                                                                           Is the substance of very
is still pending (Art. 56.1). high            No further
registered, you have the possibility to notify the Agency of your interest in that substance. The Agency shall                             to be released under normal and                      concern (Svhc)? (Art. 57)        requirements
Is there alternative supplier                        Willforeseeable conditions of use? (Art. 7.1)
your supplier apply
publish on its website the name of that substance and, on request, provide your contact details to a potential no
who will apply                             for authorisation for your use?
registrant (Article 28.5 REACH). Transition periods for registration will however not be allowed.                                                                                                          yes
•Check also Orgalime Quick Screens 2, 3 and 4 for further possible obligations. use?for your                                       13 yes                  yes
Notify the Agency within 3 months                               Notification obligations under
yes                                                                                   certain conditions and
of first supply (Art. 66.1).
•You have to register the substance (Art. 7.1).
See guideline 10                                    duty to communicate information
•If phase-in substance, make sure the substance       down the supply chain may occur.
RECOMMENDATIONS:                                       is pre-registered before 1 Dec. 2008 then register            Check Orgalime
according to transition periods (Art.
•Please be aware that authorisation may cause substance withdrawal from the market. 23).                              Quick Screen 4
•If non phase-in substance or not pre-registered
•Application for authorisation must include an analysis of alternatives (Article 62.4 REACH). Please consider
substance, register before
manufacturing/importing/putting on to market.
Article 62.4 REACH at an early stage, especially if the use of the substance is critical the your processes.
•Check also Orgalime Quick Screens 1, 3 and 4 for See guideline 7
further possible obligations.
•If Svhc, check Orgalime Quick Screen 2
Article producers/importers should pay attention under which provision of the REACH Regulation the intentionally
released substance/substance in preparation should be registered:
•If the substance that requires registration is considered as a substance delivered in a container, the substance has to
be registered according to Article 6 REACH. Please note that the container itself may be considered as an article
Guide available free of charge at
according to Article 3.3 REACH.
•If the substance to be registered is considered as a substance in an article, the substance requires registration
according to Article 7.1 REACH.
•Check also Orgalime Quick Screens 1, 2 and 4 for further possible obligations.                                                    15
www.publications.orgalime.org
 REACH : complex legislation
 New duties for inter alia downstream users,
article producers and article importers
 Important to prepare NOW
 Orgalime practical guide to understanding
http://publications.orgalime.org/
Diamant building 5th floor
Tel.:0032.(0)2.706.82.35
Fax.:0032.(0)2.706.82.50
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