Transcript High Added Value Soft Actions Facilitating Participation

BSP 2007/142-722
“Business Support Programme for Bulgaria, Romania, Croatia and
Turkey”
REACH
10th July 2008
Kwidzyn Poland
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Presentation outline
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History background
definitions
ECHA
Preregistration vs registration
exemptions
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background
 2002 Johannesbourg meeting
 Many regulations about chemical compounds
over 40 regulations
 Idea to unify the chemical market
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Registration
Evaluation
Authorisation and Restriction of
CHemicals
Regulation (EC) No 1907/2006
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This Regulation replaces:
Directive 76/769/EEC,
Commission Directive 91/155/EEC,
Commission Directive 93/67/EEC,
Commission Directive 93/105/EC,
Commission Directive 2000/21/EC,
Regulation (EEC) No 793/93
Commission Regulation (EC) No 1488/94
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Definitions
Selected definitions:
 Substance: means a chemical element and its
compounds in the natural state or obtained by
any manufacturing process, including any additive
necessary to preserve its stability and
any impurity deriving from the process used, but
excluding any solvent which may be
separated without affecting the stability of the
substance or changing its composition;
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 Preparation: means a mixture or solution composed of
two or more substances
 Article: means 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
 Producer of an article: means any natural or legal
person who makes or assembles an article within the
Community
 Registrant: means the manufacturer or the importer
of a substance or the producer or importer of an
article submitting a registration for a substance
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 Manufacturing: means production or extraction of
substances in the natural state;
 Manufacturer: means any natural or legal person
established within the Community who manufactures
a substance within the Community;
 Import: means the physical introduction into the
customs territory of the Community;
 Importer: means any natural or legal person
established within the Community who is responsible
for import;
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 Placing on the market: means supplying or making
available, whether in return for payment or free of
charge, to a third party. Import shall be deemed to be
placing on the market
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Who is concerned
 Producers/ Manufactures
 Importers
 End users
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What substances are covered
 Cancerogenic
 Mutagenic
 Reproductive toxicity
CMR
 PBT
 vPvB
…
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SDS
Safety
Data
Sheet
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SDS headings
1. identification of the substance/preparation and of the
company/undertaking
2. hazards identification
3. composition/information on ingredients
4. first-aid measures
5. fire-fighting measures
6. accidental release measures
7. handling and storage
8. exposure controls/personal protection
9. physical and chemical properties
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SDS headings
10.stability and reactivity
11.toxicological information
12.ecological information
13.disposal considerations
14.transport information
15.regulatory information
16.other information
Example of the SDS
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ECHA
European
CHemical
Agency
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http://echa.europa.eu
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About ECHA
 Based in Helsinki, Finland
 Resposible for:
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database
Registration
Examination
Providing help
Providing information about all ready registered/planed
compounds
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About ECHA
 The Agency should be financed partly by fees paid by
natural or legal persons and partly by the general
budget of the European Communities.
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Preregistration vs registration
compounds have to preregistered till
1st December 2008
Registration deadlines
 30 Nov 2010
 31 May 2013
 31 May 2018
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Timeline for registration
Source: legislastion leaflet
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Website
Registration through website
REACH-IT portal
http://echa.europa.eu/reachit_en.asp
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What you need to do before submitting
your inquiry to ECHA
 Account creation: As a potential registrant you
must sign-up in REACH-IT as explained on the
account creation page of this web section. It
will not be possible to send the inquiry if you do
not have a REACH-IT account and a UUID for
your company.
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What you need to do before submitting
your inquiry to ECHA
 Inquiry information requirements form: The
form can be accessed via the further information
heading below. You must complete the form
online, download it and save it in suitable place.
The completed form must then be attached to
section 13 of your IUCLID 5 substance dataset
during preparation of your inquiry dossier.
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What you need to do before submitting
your inquiry to ECHA
 Preparation of inquiry dossier: You must prepare
your inquiry dossier in IUCLID 5 following the
guidance in the “Manual on how to prepare an
inquiry dossier in IUCLID 5 and its submission to
ECHA”. Be sure to attach the “inquiry
information requirements form”
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What you need to do before submitting
your inquiry to ECHA
 Submission form: You must download the form
and complete it with the required information
which must match the information you used to
create your company account in REACH-IT.
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registration
First registration period till 2010
Main concern:
most dangerous
high volume
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Information for registration
 Substance Identity:
EINECS number
CAS numbers
names of the substance (IUPAC, common, other)
 Envisaged deadline and tonnage band for the
registration
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1-10 tonnes per year
10-100
100-1000
More then 1000
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Information for registration
 Name and contact information
(of a Contact person or Third party
Representative who will act as the contact point
in data sharing)
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Registration abroad EU
 Companies that manufacture substances, formulate
preparations or produce articles outside the EU cannot
(pre-)register substances. However, they can
nominate an Only Representative established within
the EU to carry out the required (pre-) registration of
their substances that are imported into the EU.
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Third Party Representative
 Cost sharing
 „Hide” some information from competitors
 Take care of commercial secrets
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Joint registration
 Joint submission of data by multiple registrants
When a substance manufactured or imported by more
than one company, they are required to submit
certain information together
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Benefits from preregistration
 More time!
 Allow the business to run
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Benefits from preregistration
 Pre-registration is free of charge, but…!
 „producer” part of a Substance Information Exchange
Forum (SIEF) until 1 June 2018 and may need to
actively participate to the SIEF activities. In addition
you may have financial obligations in relation to your
substance.
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Did not register on time?
After December 2008
 will have to submit a registration dossier for that
substance before you can continue manufacturing or
importing it in 1 tonne or more per year after 2008
 Have to wait for registration number from ECHA
 determine whether a registration or an inquiry was
previously submitted for the same substance
 Obtain and assess relevant physico-chemical, health and
environmental data and use information in order to
compile your registration dossier
 Submit the dossier and pay the related fee
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Database from ECHA
After 1 Jan 2008
 List of preregistered substances will be
published (website)
 Name
 Identity codes (CAS, EINECS,..)
 Registration deadline
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Benefits from preregistration
after 1 Dec 2008
 Only if you import or produce for the first time
 First time counts from entering law into force
1 June 2007
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exemptions
 medicinal products for human or veterinary use,
within the scope of Regulation
(EC) No 726/2004 and Directive 2001/82/EC
and as defined in Directive 2001/83/EC
 cosmetic products as defined in Directive
76/768/EEC
 medical devices which are invasive or used in
direct physical contact with the human body
Directive 1999/45/EC
 food or feeding in accordance with Regulation
(EC) No 178/2002
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exemptions
 food or feeding
 as a food additive in foodstuffs within the scope
of Directive 89/107/EEC;
 as a flavouring in foodstuffs within the scope of
Directive 88/388/EEC and Decision 1999/217/EC;
 as an additive in feedingstuffs within the scope of
Regulation (EC) No 1831/2003;
 in animal nutrition within the scope of Directive
82/471/EEC
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exemptions
 Natural resources (minerals, ores, crude oil, gas,
coke not modified)
 Common elements of which hazards are well
known (oxygen, hydrogen, nobel gases,
nitrogen)
 polymers
 exemption from the obligation to register are
listed in Annex IV
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exemptions
 Incidental reaction with air, moisture,
mircorbiogical sunlight
 Substances occuring during end use (not
intented for sell)
 Natural substances (occur in nature not
modified)
 By-products
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exemptions
 Excluded from need of registration are
substances that transit through EU
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Case
Import goods (eg. Paint, galvanic chemistry, fire
retardant) from outside EU
-will the supplier register those goods
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Useful links
 REACH Regulation EC No 1907/2006
http://eur-lex.europa.eu/JOHtml
.do?uri=OJ:L:2007:136:SOM:EN:HTML
 ECHA website: http://echa.europa.eu
 REACH-IT: http://echa.europa.eu/reachit
 REACH Guidance Documents
http://reach.jrc.it/guidance_en.htm
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