Seminar on EU Chemical Regulatory System

1
Seminar on EU Chemical Regulatory System

• REACH (Part 2)
• 17th July 2012

2
???????????????

• REACH (????)
• 2012?7?17?

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Registration Process

• If you want export to EU, it is important that,
  until now, you know
• The substances you want to export
• The state in which they are Substances, mixtures
  and / or items.
• The annual amount will be introduced in the
  European Union.
• If you do not plan to export to the European
  Union, surely one of its customers will do that
  and ask you about your products.

4
????

• ?????EU??,???????????
• ???????
• ??????????????/???
• ??EU?????
• ???????EU??,????EU???????EU??,????????

5
Registration Process

• Manufacturers and importers will need to obtain
  information on the substances they manufacture or
  import and use this information to assess the
  risks arising from the manufacture and uses of
  the substances and to ensure that the risks that
  the substances may present are controlled.
• Investment in Knowledge pays the best interest
• Benjamin Franklin

6
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• ???????????????????????????????????????????????,??
  ???????????
• ????,????
• ???????

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Registration Process

• If, through a only-representative or an importer,
  you have a pre-registration, you should prepare a
  registration dossier for you phase-in substance,
  and the deadline depends on the tonnage.
• For non phase-in substances and for phase-in
  substances that have not been pre-registered an
  inquiry must always be submitted before
  proceeding with the registration of the
  substance.
• Or, before submitting an update of a
  registration, due to a tonnage band increase, the
  registrant is obligated to inform ECHA of the
  additional information.

8
????

• ?????????????????????,?????????????????,??????????
  
• ?????????????????????,??????????????????
• ??,????????,????????,??????ECHA?????????????????

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Data sharing

• Purpose
• increase the efficiency of the registration
  system as well as to reduce costs and to reduce
  testing on vertebrate animals
• To facilitate data sharing, prior to
  registration, all substances must either be
  pre-registered or an inquiry must be submitted.
• The communication mechanism for phase-in
  substances is the Substance Information Exchange
  Forum (SIEF) established following
  pre-registration.
• For non phase-in substances the mechanism is the
  inquiry process.

10
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• ??
• ?????????,????,????????
• ???????,????,???????????????????
• ???????????????????????????(SIEF)?
• ?????????????????

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Data sharing principles

• Data must be shared for the same substance in the
  case of information involving tests on vertebrate
  animals.
• Before testing is carried out on vertebrate
  animals, a potential registrant must request
  available data either in the SIEF or through the
  inquiry process from the previous registrant.
• Information not involving tests on vertebrate
  animals must be shared if requested by a
  potential registrant of the same substance.
• The potential registrant may request the study
  he needs within the SIEF or from the previous
  registrant, as applicable.

12
??????

• ????????????,????????????????
• ???????????,????????SIEF??????????????????????????
  
• ?????????????,??????????????????,????????????
• ????????SIEF?????????????????,????

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Data sharing mechanisms aims

• To ensure that sharing of studies which are
  already available and of their related costs is
  agreed amongst potential registrants in a fair,
  transparent and non-discriminatory way.
• Importantly, in the case of lacking data, the aim
  of the sharing mechanism is for potential
  registrants of the same substance to agree who
  will undertake the necessary data collection to
  ensure that the test is carried out only once.

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?????????

• ????????????,?????????????????????????????,???????
  ???????????????????
• ?????????,?????????????????????????????????????,??
  ??????????

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Pre-registration of phase-in substances

• Each potential registrant of a phase-in substance
  in quantities of one tonne or more per year
  should have taken part in the pre-registration
  process in order to benefit from the later
  registration deadlines.
• The pre-registration mechanism allows potential
  registrants to get in contact for the purpose of
  data sharing through the formation of a SIEF

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?????????

• ??????????????1????????????????,??????????????
• ????????????????SIEF??????,????????????

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SIEF formation

• Who can join?
• All potential registrants and data holders for
  the same pre-registered phase-in substance.
• Companies that intend to register the same
  phase-in substance will join a Substance
  Information Exchange Forum (SIEF).
• Downstream users and any person or organisation
  holding data relevant to a phase-in substance can
  participate in the SIEF if they have identified
  themselves as a data holder and are willing to
  share their information.

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SIEF ??

• ????SIEF?
• ?????????????????????????
• ?????????????????????????
• ????????????????????????,????????????????????,????
  SIEF

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SIEF formation

• Joining a SIEF is a legal obligation for all
  registrants of pre-registered phase-in
  substances. Potential registrants must get active
  in their SIEFs now if they intend to register by
  31 May 2013 or by 31 May 2018.
• The work of a SIEF leads to one joint submission
  for each substance, therefore reducing costs and
  avoiding unnecessary animal testing.
• Note that the responsibility for defining the
  sameness of the substances lies with the SIEF
  participants.

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SIEF ??

• ??????????????????????SIEF??????????2013?5?31??201
  8?5?31??????,????????????SIEF???
• ??SIEF?????????????????????,????????????????????
• ???,????????????????SIEF??????

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SIEF / Consortia

• SIEFs have no prescribed legal form and they are
  independently managed by industry. ECHA is not
  involved in their operations.
• The members of the SIEF are free to choose how to
  organise their cooperation under REACH. The forms
  of cooperation can vary from a simple structure
  to a more structured and complex organisation
  (e.g. legally established consortia).
• For large SIEFs, consortia may be a more
  efficient type of cooperation to provide a
  binding means of complying with the data-sharing
  obligations and to prepare the registrations.
• There is no requirement to form consortia under
  the REACH Regulation.

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SIEF / ????

• SIEF????????????????ECHA???????
• SIEF??????REACH??????,????????????????????????,???
  ???(? ?????????)?
• ????SIEF??,???????????????????????????????????????
  ??????
• REACH?????????????

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Roles in a SIEF

• Lead registrants.
• A lead registrant must act with the agreement of
  the other co-registrants and submit the lead
  dossier of the joint submission. The lead
  registrant also usually coordinates the
  activities within the SIEF.
• REACH does not specify rules on how the lead
  registrant should be selected. For example, the
  lead registrant may be the registrant who plans
  to submit their registration dossier by the
  earliest registration deadline.
• Lead registrants are advised to inform ECHA of
  their nomination.

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SIEF??????

• ????.
• ???????????????????????????????????????????????SIE
  F??????
• REACH????????????????,????????????????????????????
  ?
• ???????ECHA?????????

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Roles in a SIEF

• Member registrants.
• Member registrants submit dossiers containing
  only information specific to their company and
  their substance, for example, information about
  substance identity, their identified uses and
  their production volumes. These submissions do
  not need to include the information already
  provided by the lead registrant.

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SIEF??????

• ?????.
• ????????????????????????,?????????????????????????
  ????????????

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Joint Dossier

• Multiple registrants of the same substance are
  required by the REACH Regulation to jointly
  submit information on the intrinsic properties of
  the substance.
• The REACH Regulation only requires that the lead
  registrant submits the joint part of the
  registration dossier.
• Joint registration dossiers shall be submitted
  first by the lead registrant-

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????

• REACH??????????????????????????????
• REACH?????????????????????
• ?????????????????

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Data Sharing Agreements

• SIEF members need to get an overview of the
  studies available among the SIEF members and
  agree on the need to generate new test data when
  information is missing.
• Before conducting any new study involving testing
  on vertebrate animals, SIEF members shall request
  whether the study is already available from other
  participants within the SIEF. If the owner of an
  existing study refuses to provide either the
  proof of costs for the study or the study itself,
  the REACH Regulation sets rules to settle such
  data sharing .disputes

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??????

• SIEF ???????SIEF???????????????????,??????????????
  ??
• ?????????????,SIEF??????SIEF??????????????????????
  ????????????????????????,REACH?????????,??????????
  ????

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Data Sharing Agreements (2)

• Before conducting any new study not involving
  testing on vertebrate animals, SIEF members may
  ask other participants whether they already have
  those studies. However, if the owner of a study
  refuses to provide either the proof of costs for
  the study or the study itself, the other SIEF
  member(s) need to proceed with registration as if
  no relevant study is available within the SIEF.

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??????(2)

• ?????????????????,SIEF????????????????????????,???
  ???????????????????????,???SIEF???????????,??SIEF?
  ???????????

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Data Sharing Agreements (3)

• If a study is not available within a SIEF, only
  one study per information requirement shall be
  conducted by a SIEF member acting on behalf of
  the others.
• If the missing study is listed in Annexes IX (and
  X) of the REACH Regulation (information
  requirements for tonnage bands gt 100 tonnes per
  annum), the SIEF members cannot proceed with the
  testing directly but have to first submit a
  testing proposal in their joint registration
  dossier.

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??????(3)

• ???SIEF??????????,????SIEF????????????????,??????(
  ??????
• ????????????REACH????? IX (?X) (???? gt 100??????
  ),SIEF????????????,?????????????????????

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The inquiry dossier

• There are two options to prepare and submit an
  inquiry dossier for non phase-in and non
  pre-registered phase-in substances
• Preparing an inquiry dossier with REACH-IT
• Preparing an inquiry dossier with IUCLID 5

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????

• ?????????????????????????????
• ??REACH-IT ??????
• ??IUCLID5??????

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REACH-IT

• The REACH-IT system is a central system that runs
  at ECHA. REACH-IT has two fundamental groups of
  parties for which it provides appropriate
  functions.
• Industry interface this is the place where a
  company can, for example, sign-up, pre-register
  substances, obtain contact details of other
  companies having pre-registered the same
  substance, submit registrations, download
  invoices and view the status of submitted
  registrations and payments. In addition, it
  allows dossier preparation, e.g. Inquiry.
• Users manufacturers, importers, third party
  representatives, Only Representatives, downstream
  users.
• Agency interface this part of REACH-IT supports
  the day to day work in the regulatory process
  management of ECHA.
• The users of the Agency interface are ECHA staff
  and MSCA staff.

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REACH-IT

• REACH-IT???ECHA????????REACH-IT ??????????????
• ???? ???????,???????????,?????????????????????,??
  ??,????,??????????????,???????,?????
• ?? ???????????????????????
• ???? REACH-IT???????ECHA????????????
• ????????ECHA(????????)?MSCA(???????)???

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Differences between REACH-IT and EUCLID 5
REACH-IT IUCLID 5
Web-based application 1- Client.Server application 2- Stand-alone application Decentralised system, installed locally
Restricted to REACH Regulation Used globally, and for other regulatory purposes in addition to REACH (e.g. OECD High Production Volume chemicals program (HPV), EU Biocides legislation, etc,
Application where dossiers are submitted by users Application which captures and stores information on chemicals for various regulatory purposes, globally.
Multi-party system where Industry and Authority parties co-exist Each installation is essentially a single party-system.
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REACH-IT ? EUCLID 5???
REACH-IT IUCLID 5
????????? 1- ?????????? 2- ??????? ?????????
???REACH?? ????,??REACH,?????????(?OECD?????????HPV?EU??????)
???????????? ??????????????????????????
???????????? ?????????????
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REACH-IT
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REACH-IT
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IUCLID 5
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IUCLID 5
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IUCLID 5

• IUCLID 5 is the software application developed
  for a provided to Industry, free of charge, to
  capture and store data on usersown substances in
  their local IT environment and submit these data
  in the correct format to ECHA.
• For more information on IUCLID 5, see the IUCLID
  5 website at http//iuclid.eu

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IUCLID 5

• IUCLID 5 ????????????????????,???????IT???????????
  ?????????????????????ECHA?
• ????IUCLID5????????http//iuclid.eu

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Steps for creating an inquiry dossier

• Step 1.- Creating the legal entity for the
  inquirer.
• Step 2.- Creating the reference substances
  related to the inquired about substance.
• Step 3.- Creating the substance dataset for the
  inquired about substance.
• Step 4.- Entering information on the inquired
  about substance.
• Step 5.- Creating an inquiry dossier
• Step 6.- Exporting the inquiry dossier from
  IUCLID 5
• Step 7.- Submitting the inquiry dossier to ECHA.

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?????????

• ?? 1.- ??????????
• ?? 2.- ???????????????
• ?? 3.- ????????????
• ?? 4.- ???????????
• ?? 5.- ??????Creating an inquiry dossier
• ?? 6.- ?IUCLID5???????
• ?? 7.- ?ECHA??????

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The inquiry dossier

• Identity of the inquirer
• This will include contact details and the
  location of the inquirer's production site, where
  relevant for the purposes of data sharing.
• The Legal entities are used in IUCLID 5 to
  provide contact details on the companies involved
  in processes under REACH.
• Substance identity
• The information required for substance identity
  is identical to that required in the technical
  dossier for registration (Annex VI (2)).
  Therefore the work done in the inquiry dossier,
  will serve for the subsequent registration
  dossier.
• In IUCLID 5, the information related to that
  substance (such as the identity of the substance,
  its composition, etc.) should be specified in the
  Substance dataset created for that substance.

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????

• ?????
• ????????????????,????????????
• IUCLID5??????????REACH???????????
• ????
• ????????????????(??VI (2))?????????????,??????????
  ????????????
• ? IUCLID 5?,????????????????,??????????(?????????)
  ?????

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Reference Substance

• Reference substance is a link to the identity of
  a chemical.
• The concept of a Reference substance enables you
  to store identification information on a given
  substance or a given constituent of a substance,
  such as chemical names (EC name, CAS name, IUPAC
  name, synonyms, etc), identity codes (e.g. EC
  number, CAS number), molecular and structural
  information, in a central place. This information
  can then be re-used in other datasets without
  having to retype the information. The Reference
  substance inventory is directly maintained by
  you, in your local installation.

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????

• ??????????????
• ???????????????????????????????,???????(EC???CAS??
  ?IUPAC???????)????(?EC?,CAS?)?????????????????????
  ????????????????,????????????????????????????????

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Reference Substance

• You can download the ca. 70,000 pre-filled
  Reference substances from the IUCLID 5 web site
  and import them to your local installation.
• You should also download the EC inventory from
  the IUCLID 5 web site (unless already done during
  the IUCLID 5 installation). This inventory
  consists of a list of substance identities which
  is based on a combination of the following EU
  inventories EINECS, ELINCS and NLP-list.

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????

• ????IUCLID5??????ca. 70,000?????????????????????
• ????IUCLID5??????EC??(???IUCLID5???????)??????????
  ?EU????EINECS, ELINCS ?NLP????????

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Completed reference substance
56
????????
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Substance dataset

• To create an inquiry dossier in IUCLID 5, you
  need first to create a Substance dataset. A
  Substance dataset is the repository of data,
  which is used as a basis to create the dossier to
  be submitted to the ECHA.

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?????

• ?IUCLID 5???????,????????????????????????,??????EC
  HA??????

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Selecting the template from the pick-list
Mandatory sections are marked with red in IUCLID
5 and optional sections in green
60
??????????
Mandatory sections are marked with red in IUCLID
5 and optional sections in green
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General Information

• Identification
• Name of the substance (Using reference substance
  or creating a new).
• Contact person. Although the contact details of
  your company are specified in the Legal entity,
  you can also indicate the information details of
  the contact person for that specific substance.

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????

• ??
• ???? (???????????)
• ??????????????????????,??????????????????????

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General Information

• Composition
• Monoconstituent
• Specify indentity and composition of the
  monoconstituent.
• UCVB
• Specify the identity of the UVCB.
• Specify the composition of the UCVB
• Multiconstituent
• Specify the composition of the multiconstituent
• Specify the identity of the multiconstituent

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????

• ??
• ???
• ???????????
• UCVB??????
• ??UVCB??
• ??UCVB??
• ???
• ???????
• ???????

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General Information
Remember to follow the same procedure to complete
the impurities and additives fields
66
????
??????????????
67
General Information
68
????
69
Analytical information

• Analytical methods and spectral data field
• Describe the analytical methods used to
  characterise your substance, and where
  appropriate, the impurities and additives
• Optical activity field
• Provide information on the optical activity and
  typical ratio of isomers, where applicable.
• Provide the analytical results to characterise
  the substance, such as spectral data (UV, IR,
  NMR, MS,.), chromatographic data,..

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????

• ???????????
• ???????????,???,???????????????
• ??????
• ????????????????(???)
• ???????????,?????? (UV, IR, NMR, MS,.), ????,..

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Production site

• Specify your role in the supply chain
• Manufacturer, Importer, Only representative,
  Producer of article, Manufacturer and Importer,
  Manufacturer and Producer of article, Manufacture
  and Importer and Producer of article.
• Provide the location of your production site.
• If you are EU manufacturer and EU Producers of
  articles is mandatory.
• If you are an importer or only representative,
  ECHA recommend this.

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????

• ?????????????
• ??????????????????????????????????????????????????
  
• ????????
• ???????EU????EU???,??????????
• ????????????,ECHA???????????

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Tonnage band information band

• ANNEX VII (1 tonne or more)
• ANNEX VIII (10 tonnes or more)
• ANNEX IX (100 tonnes or more)
• ANNEX X (1000 tonnes or more)

74
???? ????

• ?? VII (1 ????)
• ?? VIII (10 ????)
• ?? IX (100 ????)
• ?? X (1000 ????)

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ANNEX VII (1 tonne or more)

• 7 Information on the physicochemical properties
  of the substance
• 7.1 State of the substance (at 20 ºC and 101,3
  kPa)
• 7.2 Melting/freezing point
• 7.3 Boiling point
• 7.4 Relative density
• 7.5 Vapour pressure
• 7.6 Surface tension
• 7.7 Water solubility
• 7.8 Partition coefficient n-octanol/water
• 7.9 Flash point
• 7.10 Flammability
• 7.11 Explosive properties
• 7.12 Self ignition temperature
• 7.13 Oxidising properties
• 7.14 Granulometry

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?? VII (1 ????)

• 7 ??????????
• 7.1 ???? (? 20 ºC ? 101,3 kPa)
• 7.2 ??/??
• 7.3 ??
• 7.4 ????
• 7.5 ??
• 7.6 ????
• 7.7 ???
• 7.8 ???-?????
• 7.9 ??
• 7.10 ???
• 7.11 ???
• 7.12 ????
• 7.13 ????
• 7.14 ??

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ANNEX VII (1 tonne or more) (2)

• 8 Toxicological information
• 8.1 Skin irritation or skin corrosion (in vitro)
• 8.2 Eye irritation (in vitro)
• 8.3 Skin sensitisation (in vivo)
• 8.4.1 Mutagenecity (gene mutation in bacteria)
• 8.5.1 Acute toxicity (by oral route)
• 9 Ecotoxicological information
• 9.1.1 Short term aquatic toxicity on
  invertebrates(Daphnia)
• 9.1.2 Growth inhibition aquatic plants (algae)
• 9.2.1.1 Ready biodegradability

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??VII (1 ????) (2)

• 8 ????
• 8.1 ?????????(??)
• 8.2 ????(??)
• 8.3 ????(??)
• 8.4.1 ???(??????)
• 8.5.1 ????(????)
• 9 ???????
• 9.1.1????????????? (??)
• 9.1.2????????(??)
• 9.2.1.1???????

79
ANNEX VIII (10 tonnes or more)

• 8 Toxicological information
• 8.1.1 Skin irritation (in vivo)
• 8.2.1 Eye irritation (in vivo)
• 8.4.2 Cytogenicity in mammalian cells (in vitro)
• 8.4.3 Gene mutation in mammalian cells (in vitro)
• 8.5.2 Acute toxicity (by inhalation)
• 8.5.3 Acute toxicity (by dermal route)
• 8.6.1 Short-term repeated dose toxicity test (28
  days)
• 8.7.1 Screening for reproductive/developmental
  toxicity
• 8.8.1 Toxicokinetics
• 9 Ecotoxicological information
• 9.1.3 Short-term aquatic toxicity to fish
• 9.1.4 Activated sludge respiration inhibition
  test
• 9.2.2.1 Hydrolysis as a function of pH
• 9.3.1 Adsorption/desorption screening

80
?? VIII (10 ????)

• 8 ????
• 8.1.1 ????(??)
• 8.2.1 ????(??)
• 8.4.2??????????????(??)
• 8.4.3???????????(??)
• 8.5.2????(??)
• 8.5.3????(???)
• 8.6.1??????????(28?)
• 8.7.1?????????
• 8.8.1?????
• 9???????
• 9.1.3??????????
• 9.1.4??????????
• 9.2.2.1 ????pH????
• 9.3.1??/????

81
ANNEX IX (100 tonnes or more)

• 7 Information on the physicochemical properties
  of the substance
• 7.15 Stability in organic solvents and identity
  of relevant degradation products
• 7.16 Dissociation constant
• 7.17 Viscosity
• 8 Toxicological information
• 8.6.1 Short-term repeated dose toxicity test (28
  days)
• 8.6.2 Sub-chronic toxicity (90 days)
• 8.7.2 Pre-natal developmental toxicity
• 8.7.3 Two-generation reproductive toxicity

82
?? IX (100 ????)

• 7 ??????????
• 7.15 ????????????????????
• 7.16 ????
• 7.17 ??
• 8 ????
• 8.6.1??????????(28?)
• 8.6.2 ?????(90?)
• 8.7.2????????
• 8.7.3 ??????

83
ANNEX IX (100 tonnes or more) (2)

• 9 Ecotoxicological information
• 9.1.5 Long-term aquatic toxicity on invertebrates
  (Daphnia)
• 9.1.6 Long-term aquatic toxicity on fish
• 9.2.1.2 Ultimate degradation in surface water
• 9.2.1.3 Soil simulation testing
• 9.2.1.4 Sediment simulation testing
• 9.2.3 Identification of degradation products
• 9.3.2 Bioaccumulation in aquatic species (fish)
• 9.3.3 Further information on adsorption/desorption
  
• 9.4.1 Short-term terrestrial toxicity on
  invertebrates
• 9.4.2 Effects on soil micro-organisms
• 9.4.3 Short-term terrestrial toxicity to plants

84
?? IX (100 ????) (2)

• 9 ???????
• 9.1.5???????????????(??)
• 9.1.6????????????
• 9.2.1.2???????
• 9.2.1.3??????
• 9.2.1.4???????
• 9.2.3??????
• 9.3.2???????? (??)
• 9.3.3 ??/???????
• 9.4.1?????????????
• 9.4.2 ????????
• 9.4.3??????????

85
ANNEX X (1000 tonnes or more)

• 8 Toxicological information
• 8.6.3 Long-term repeated dose toxicity ( 12
  months)
• 8.7.2 Developmental toxicity
• 8.7.3 Two-generation reproductive toxicity
• 8.9.1 Carcinogenicity
• 9 Ecotoxicological information
• 9.2 Further biotic degradation testing
• 9.3.4 Further information on the environmental
  fate and behaviour of the substance and/or
  degradation products
• 9.4.4 Long-term terrestrial toxicity to
  invertebrates
• 9.4.6 Long-term terrestrial toxicity to plants
• 9.5.1 Long-term toxicity to sediment organisms
• 9.6.1 Long-term or reproductive toxicity to birds

86
?? X (1000 ????)

• 8 ????
• 8.6.3????????(12??)
• 8.7.2????
• 8.7.3 ??????
• 8.9.1 ???
• 9 ???????
• 9.2??????????
• 9.3.4 ???????/????????????????
• 9.4.4??????????????
• 9.4.6???????????
• 9.5.1????????????
• 9.6.1???????????

87
Create Inquiry Dossier from EUCLID
88
?EUCLID??????
89
Create Inquiry Dossier from EUCLID
90
?EUCLID??????
91
Submitting an inquiry dossier

• Go to ECHA website to access REACH-IT.
• In REACH-IT, sign-up as a company
• User account
• Company information. For consistency with IUCLID,
  you should import the Legal Entity Object.
• Billing Information
• Contacts
• Validation
• Submit the IUCLID 5 inquiry dossier

92
??????

• ??ECHA??,?? REACH-IT??
• ?REACH-IT???, ??????
• ????
• ???? ??IUCLID????,?????????
• ????
• ????
• ??
• ?? IUCLID 5 ????

93
I submit my inquiry dossier to ECHA. What
happens next?

• Once ECHA has received your inquiry dossier it
  will go through some mandatory submission checks
  and then the dossier will be assessed.
• If ECHA is able to process your inquiry dossier,
  you will receive via REACH IT a communication
  which states your inquiry number and information
  on previous registrants and other inquirers of
  the same substance as well as details of
  available (robust) study summaries, as
  appropriate .
• If ECHA is not able to process your inquiry
  dossier, due to insufficient and/or inconsistent
  information provided on substance identification,
  you will receive via REACH IT a communication
  detailing additional information required

94
???????EHCA?,????

• ???????ECHA??,????????????????,???????
• ??ECHA??????????,?????REACH-IT???????,????????????
  ???????????????????(??)??????(?????)?
• ????????????????/???????ECHA??????????,????REACH-I
  T???????,?????????????

95
I submit my inquiry dossier to ECHA. What
happens next?

• You need to wait until you have received a
  communication from ECHA stating your inquiry
  number before submitting your registration as you
  may have legal obligations to submit a joint
  registration and share data.
• The information submitted for the purposes of
  inquiry will be treated as confidential and will
  not be published on the dissemination website.
• If ECHA has indicated some changes to be done in
  our inquiry dossier but has provided us with an
  inquiry number, you do not need to submit another
  inquiry dossier for this substance.

96
???????EHCA?,????

• ??????,?????????ECHA??????,???????????????????????
  ???????????
• ???????????????????????????
• ??ECHA???????????????,????????,????????????????

97
Data sharing process following an inquiry
98
??????????
99
PPORD Exemption

• Substances intended to be used for product and
  process orientated research and development
  (PPORD) can be exempted from the obligation of
  registration for a period of five years.
  Companies that wish to benefit from this
  exemption must submit a PPORD notification to
  ECHA.
• Companies have to include in the notification the
  information on substance identity, its
  classification, information related to the PPORD
  programme, and the quantity of the substance
  expected to be manufactured or imported during
  the five-year period of exemption
• You can submit a PPORD notification to ECHA in
  order to be exempted from the obligation to
  register using IUCLID 5, in a similar way as
  Inquiry Dossier.

100
PPORD ??

• ?????????(PPROD)???????????????????????????ECHA??P
  PROD???
• ???????????????????PPROD??????????????????????????
  ????
• ???????,??????IUCLID5?????,????EHCA??PPROD???

101
PPORD Dossier
102
PPORD ??
103
Registration dossier

• The registration dossier is the set of
  information submitted electronically by a
  registrant for a particular substance
• Structure of the registration dossier.
• a technical dossier, always required for all
  substances subject to the registration
  obligations
• a chemical safety report, required if the
  registrant manufactures or imports a substance in
  quantities of 10 tonnes or more per year.

104
????

• ???????????????????????
• ??????
• ????,??????????????
• ??????,,?????????????????????10????

105
Chemical safety report

• It contains a detailed summary of information on
  the environmental and human health hazard
  properties of the substance, together with an
  assessment of exposure and risk where such an
  assessment is required.
• It is the key source from which the registrant
  provides information to all users of chemicals
  through the exposure scenarios.
• The CSR format is defined in Annex I of REACH.

106
??????

• ??????????????????????????????????????(???)?
• ????????????????????????????
• CSR???REACH??I ?????

107
Registration dossier

• Format of the registration dossier
• The format of the registration dossier must be
  IUCLID.
• Submission of the registration dossier
• Each manufacturer or importer or only
  representative is individually obliged to submit
  a registration dossier for each of his substances

108
????

• ??????
• ??????????IUCLID?
• ??????
• ??????????????????????????????????

109
Joint submission of data

• The joint submission of data applies both for the
  registration of phase-in substances and that of
  non phase-in substances.
• Registrants are required to jointly submit
  information on the intrinsic properties of the
  substance (studies and testing proposals, if any)
  and its classification and labelling and can, if
  they agree to do so, also jointly submit the
  guidance on safe use and the chemical safety
  report (CSR)
• The joint submission of data does not eliminate
  the obligation for each registrant (manufacturer,
  importer or only representative) to also submit
  an individual dossier

110
???????

• ???????????????????????
• ?????????????????(????????,???)???????????????????
  ,???????????????????(CSR)?
• ????????????????(??????? ?????)??????????

111
Information requirements in joint submissions
Information requirements Lead dossier Lead dossier Member Dossier
Information requirements Joint information Individual information Individual information
(a) Technical dossier
(i) identity of the manufacturer or importer X X
(ii) identity of the substance X X
(iii) manufacture and use(s) of the substance and if relevant use and exposure categories X X
(iv) classification and labelling X
(v) guidance on safe use upon agreement upon agreement upon agreement
(vi) study summaries of information derived from the application of Annexes VII to XI X
112
?????????
???? ??? ??? ????
???? ???? ???? ????
(a) ????
(i) ????????? X X
(ii) ???? X X
(iii) ??????????????????? X X
(iv) ????? X
(v) ?????? ???? ???? ????
(vi) ???VII???XI???????????? X
113
Information requirements in joint submissions
Information requirements Lead dossier Lead dossier Member Dossier
Information requirements Joint information Individual information Individual information
(a) Technical dossier
(vii) robust study summaries of the information derived from the application of Annexes VII to XI if required under Annex I X
(viii) indication regarding the review by an assessor of information submitted under (iii), (iv), (vi), (vii) and (b) X X X
(ix) proposals for testing X
(x) exposure information for substances in quantities of 1 to 10 tonnes X X
114
?????????
???? ??? ??? ????
???? ???? ???? ????
(a) ????
(vii) ???I???,????VII???XI???????????????? X
(viii)???(iii), (iv), (vi), (vii) and (b)???????????? ???????? X X X
(ix) ???? X
(x) ???1?10????????? X X
115
Information requirements in joint submissions
Information requirements Lead dossier Lead dossier Member Dossier
Information requirements Joint information Individual information Individual information
(a) Technical dossier
(xi) request as to which information in Article 119(2) should not be made available on the Internet X X X
(b) Chemical safety report upon agreement upon agreement upon agreement
116
?????????
???? ??? ??? ????
???? ???? ???? ????
(a) ????
(xi)??? 119(2)?????????????????? X X X
(b) ?????? ???? ???? ????
117
Joint submission of data

• Only once the lead dossier for the joint
  submission is accepted for processing, in other
  words has passed the business rules check step,
  may members submit their member dossiers.
• When a potential registrant prepares to register
  a non phase-in substance and the inquiry process
  results in finding that one or several
  registrations have previously been submitted for
  the same substance, the potential registrant will
  not only need to share data with the previous
  registrants, but he will also need to be part of
  the joint submission

118
???????

• ??????????????????,????????????,????????????
• ????????????????????????????????????????????,?????
  ??????????????????,??????????

119
Opt-out possibilities

• A manufacturer or importer may submit certain
  information of the registration dossier
  separately (opt-out) in cases where at least one
  of the following reasons (listed in Article 11(3)
  or for substances in intermediates respectively
  in Article 19(2)) applies
• a) it would be disproportionately costly for him
  to submit this information jointly or
• (b) submitting the information jointly would lead
  to disclosure of information which he considers
  to be commercially sensitive and is likely to
  cause him substantial commercial detriment or
• (c) he disagrees with the lead registrant on the
  selection of the information submitted in the
  lead registration.
• The registrant remains a member of the joint
  submission and will be able to submit his dossier
  only after the lead dossier has been accepted for
  processing

120
??????????

• ???????????(??11?(3))?????19?(2)??????????????????
  ,??????????????(??????)??????????
• a) ??????????????????
• (b) ??????????????????????????????????????????
• (c) ????????????????????
• ???????????????,?????????????????????

121
Access to information and confidential data

• If justified, some pieces of information can be
  claimed confidential for reasons to commercial
  interest of the registrant or any other part.
• the degree of purity of the substance and the
  identity of impurities and/or additives.
• the total tonnage band,
• The registrant may identify certain information
  listed in Article 119 as confidential in his
  registration dossier for reasons of commercial
  interests,

122
??????????

• ????,??????????????,???????????
• ?????????/???????
• ?????
• ??????,??119????????????????,?????????

123
Preparation of the registration dossier
124
???????
125
Preparation of the registration dossier

• General information on the registrant and on the
  registered substance.
• Information regarding the registrant
  identification.
• Information regarding the role(s) of the
  registrant.
• Information required for traceability purposes.
• Information regarding the joint submission if
  applicable.
• Information required for the identification of
  the substance

126
??????

• ?????????????
• ?????????
• ?????????
• ?????????
• ????????(???)
• ??????????

127
Preparation of the registration dossier

• Classification and labelling.
• The registrant has to determine the
  classification and labelling of his substance
  with respect to physico-chemical properties,
  environment and human health.
• Within a joint submission, the lead dossier can
  propose several classifications. If a registrant
  disagrees, then he needs the opt-out option.
• Registration dossiers submitted from 1 December
  2010, must include information according to the
  CLP criteria.
• Classification and labelling inventory from
  ECHA. Contain information from substances.

128
??????

• ?????
• ????????????????,??????????????????????
• ??????,??????????????????????,????????????
• ?2010?12?1?????????????CLP?????????
• ECHA????????????????

129
Preparation of the registration dossier

• Manufacture, use and exposure.
• Section 3 of Annex VI.
• At least the following data must be provided
• Tonnage manufactured, imported or used for
  article production in tonnes per year
• Brief description of the technological process
  used (not applicable for importers).
• Information on the form and the physical state.
• Information on waste quantities and composition
  of waste.
• Brief description of the identified uses of the
  substance.
• Information on the uses advised against and why

130
??????

• ????????
• ??VI???
• ?????????
• ???????????????????
• ????????????(???????)
• ??????????
• ??????????????
• ???????????
• ??????????

131
Preparation of the registration dossier

• Manufacture, use and exposure.
• For substances manufactured or imported between 1
  and 10 tonnes per year for which no CSR is
  required, the registrant will have to provide
  information on exposure as specified under
  section 6 of Annex VI.
• This information will include at least the types
  of use for the substance (industrial,
  professional or consumer), the significant routes
  for human and environmental exposure and the
  pattern of exposure .

132
???????

• ????????
• ???CSR??????????????1?10????,?????????VI??????????
  ?????
• ????????????????(?????????)????????????????????

133
Preparation of the registration dossier

• Information requirements on intrinsic properties
• All relevant available information on the
  physicochemical, toxicological and
  ecotoxicological properties of the substance as
  specified under Annexes VII to X (and its
  adaptations according to Annex XI) have to be
  provided in the form of study summaries or
  robust study summaries.
• It is recommended to provide robust study
  summaries for all key studies including for
  substances manufactured or imported at less than
  10 tonnes per year.
• A robust study summary is a detailed summary of
  the objectives, methods, results and conclusions
  of a full study report providing sufficient
  information to make an independent assessment of
  the study minmising the need to consult the full
  study report

134
??????

• ???????????
• ??VII???X(??????XI?????)?????????????,????????????
  ??????????????????????????????
• ??????????,????????????10??????????,?????????
• ???????????????????????????????,???????????????,??
  ?????????????

135
Preparation of the registration dossier

• Guidance on safe use
• The registrant will have to report the following
  information (as required under section 5 of Annex
  VI)
• First aid measures
• Fire-fighting measures
• Accidental release measures
• Handling and storage
• Transport information
• Where a CSR is not required, the following
  additional information is also required
• Exposure controls and personal protection
  measures
• Stability and reactivity
• Disposal information

136
??????

• ??????
• ??????????(????VI?5????)
• ????
• ????
• ??????
• ?????
• ????
• ??CSR??,?????????
• ???????????
• ???? ???
• ???????

137
Preparation of the registration dossier

• Review by an assessor
• The registrant is required to indicate in the
  technical dossier which of the following
  information has been reviewed by an assessor
  chosen by him with appropriate experience in the
  field
• Information on the manufacture and use
• Classification and labelling of the substance
• (Robust) Study summaries on the information
  requirements defined in Annexes VI to X
• Chemical Safety Report

138
??????

• ?????
• ?????????????????????????????????????????????
• ???????
• ???????
• ??VI???X?????????(??)????
• ??????

139
Dossier Submission

• ECHA assigns a submission number to each received
  dossier. This number is used as a reference in
  all correspondence relating to this registration
  until a registration number is assigned.
• Dossier submission and all correspondence are
  done via REACH-IT.
• Administrative checks
• All dossiers undergo administrative checks called
  Business Rules'' checks to ensure that the
  dossiers fulfil the pre-requisites for ECHA to
  handle them.
• If there is a business rules failure, the
  registrant would need to correct the dossier and
  submit it again.

140
????

• ECHA??????????????,?????????,?????????????????????
  ????
• ?????????????REACH-IT???
• ????
• ????????????????????????????????ECHA???????
• ???????????,?????????????????

141
Dossier Submission

• The next step is the technical completeness
  check.
• If there is any missing information, the
  registrant will be given a reasonable deadline to
  re-submit a complete dossier. Only one additional
  submission attempt is allowed in this case.
• In parallel to the technical completeness check,
  the invoice is sent to the registrant via
  REACH-IT and must be paid within the given due
  dates.

142
????

• ????????????
• ?????????,????????????????????????????????????????
  ???
• ??????????,????REACH-IT?????????????????????

143
Dossier Submission

• Decision.
• Once the technical completeness check is
  successful and the invoice is paid, the dossier
  is considered complete and a registration number
  is assigned. The registration date is the date of
  the registration dossier's submission.
• If there is a second completeness check failure
  or a failure in paying the relevant fee, the
  dossier is rejected.

144
????

• ??
• ?????????????,??????,??????????,??????????????????
  ????
• ?????????????,?????????,???????

145
Communication in the supply chain

• Companies that supply registered substances need
  to include the registration number and exposure
  scenarios in the safety data sheets that are to
  be provided to their customers.

146
???????

• ?????????????????????????????????????

147
Registration update

• Registrants have a responsibility to keep their
  dossiers updated.
• Some of the reasons are
• Change of the substance composition,
• The increase of the tonnage band or
• The availability of additional information
• The new information has to be submitted to ECHA
  without undue delay.

148
????

• ???????????
• ??????
• ??????
• ???????
• ?????????
• ?????????ECHA,????????