Impact of REACH on the industry

1
Impact of REACH on the industry
The Wercs 2006 EU users groupNice, May 18th
2006
Anne Rathmann Pedersen DTC Health Environmenta
business unit in the DHI Group
2
What is the impact?
Increasing requirements to safe use of chemicals

• Fulfill requirements
• More paperwork
• Increasing costs
• Stop in chemical supply
• Modifications of products/production

3
Requirements on the Industry

• Ensure that the chemicals do not harm the human
  health or the environment during its manufacture,
  use and disposal

Registration Authorisation and communication of
safe use of CHemicals
4
Requirements in REACH
Producers of substances and articles Importers
of substances, preparations or articles Downstr
eam Users of substances or preparations
Registration/Authorisation Fulfill and
communicate ES
Registration/Authorisation Fulfill and
communicate ES
Fulfill and communicate ES Prepare chemical
safety assessment
5
Registration
All substances produced or imported in an amount
of 1 tonne or more per year

• New substances
• Before production or import
• Phase-in substances
• Pre-registration all after 18 months of EIF of
  REACH
• Transitional regime, deadline 3, 6 or 11 years
  EIF of REACH tonnage dependent
• Non phase-in substances
• The Agency shall assign registration number
  within 18 months of EIF of REACH

6
Registration
New substances Substances to be placed on the
European market Phase-in substances Existing
substances Substances listed in the
EINECS Non-Phase-in or Notified
substances Notified in accordance with DIR
67/548/EEC Substances listed in the ELINCS
7
Pre-Registration

• Duty for phase-in substances, to benefits from
  the transitional regime
• Information to be submitted to the Agency
• Substance identity name, CAS no., EINECS no. or
  others
• Name and address of contact person
• The envisaged deadline for registration/tonnage
  band
• Identity on substances for which available
  information is relevant for the application of
  SAR and grouping of substances and read-across
  approach

8
Pre-Registration
Actors submitted information on the same
substances shall be participants in a SIEF
Substance identity on Agencys website Other
actors may submit information on the substances
on the website in order to be part of SIEF
SIEF - Substance information exchange forum SIEF
participants shall provide other participants
with existing studies, react to requests by other
participants for information, collectively
identify needs for further studies and arrange
for them to be carried out. Each SIEF shall be
operational until 11 years after EIF of REACH.
9
SIEF
10
Registration

• The transitional regime phase-in substances
• After 3 years CMR Cat. 12, 1 tonne/year
• Possible PBT (R50-53) 100 tonnes/year
• Substances 1000 tonnes/year
• After 6 years Substances 100 tonnes/year
• After 11 years Substances 1 tonnes/year

11
Registration

• Technical dossier (1 tonnes or more/year)
• Identity of registrant
• Substance identity incl. classification and
  labelling
• Manufacture and use all identified uses
• Guidance on safe use
• Study summaries (Annex V-IX) physicochemical
  properties, toxicological and ecotoxicological
  information
• Test proposals ( 100 tonnes/year)
• Exposure information (1-10 tonnes/year)
• Request not to publish information on Agency
  website
• Chemical safety report (10 or more tonnes/year)
• Documentation of safe manufacture, use and
  disposal
• Chemical safety assessment
• Exposure assessment and risk characterisation for
  substances classified as dangerous including
  exposure scenario, ES

12
Registration

• Joint submission Technical dossier
• Lead registrant to submit
• Classification and labelling
• Study summaries (Annex V-IX) physicochemical
  properties, toxicological and ecotoxicological
  information
• Test proposals ( 100 tonnes/year)
• Each registrant to submit
• Identity of registrant
• Substance identity
• Manufacture and use all identified uses
• Exposure information (1-10 tonnes/year)
• To decide
• Guidance on safe use

13
Authorisation

• Substances of very high concern, SVHC
• Annex XIII substances
• CMR, Cat. 12
• PBT, vPvB
• Endocrine disruptors, and substances considered
  to have equivalent level of concern to those
  mentioned above

14
Authorisation

• SVHC only to be placed on the market if
• The use has been authorised
• The use is exempted from authorisation
• The date is before the sunset date
• The date is after the sunset date, but decision
  not taken
• Authorisation has been granted to immediate DU

15
Authorisation

• Agency to recommend inclusion of SVHC in Annex
  XIII
• Priority given to
• PBT or vPvB
• Wide dispersive use or
• High volumes
• First recommendation no later than two years EIF
  of REACH, further recommendations at least every
  second year
• Recommendation available on Agencys website
• The Commission takes the final decision
• Candidate list for inclusion in Annex XIII
• Agency or Member state prepare Dossier (Annex
  XIV)
• Agency to publish note on Website before
  inclusion in the candidate list

16
Authorisation

• Application content
• Substance identity
• Information on contact person
• Request for authorisation, which uses are sought
• Chemical safety report
• Technical and economic analysis of alternatives
• May contain
• Socio-economic analysis
• Substitution plan
• Justification if risks to human health or the
  environment is not considered

• Application procedure
• Draft opinion from Committees for Risk Assessment
  and Socio-economic Analysis within 10 month
• Information on website, deadline for information
  on alternatives
• Final opinion taking argumentation into account
  by the Agency
• Final decision by the Commission
• Summary of decision and authorisation no. public
  available

17
Authorisation

• Granting of authorisation if
• The risk to human health and the environment is
  adequately controlled
• The exposure do not exceed the DNEL or PNEC
• The likelihood and severity of an event occurring
  due to the intrinsic properties is negligible
• Not valid for CMR substances without a threshold
  value (DNEL/PNEC) and for PBT and vPvB substances

• Socio-economic benefits outweigh the risks and if
  no alternatives are available. Based on
  considerations of all the following
• Risk posed by the use
• Socio-economic benefits and implications if auth.
  is not granted
• Analysis of alternatives
• Availability of information on risk of
  alternatives

18
Authorisation

• Valid until Commission decides to amend or
  withdraw
• The authorisation specifies
• Information on the person granted the
  authorisation
• Substance identity
• Uses that are granted authorisation
• Conditions for granting the authorisation
• Time-limited review period (case by case)
• Any monitoring arrangement

• Review of the authorisation
• Review report to be submitted by the holder of
  the authorisation at least 18 months before
  expiry of the time-limited period.
• Update of substitution plans, socio-economic
  analysis, analysis of alternatives, or chemical
  safety report
• Update of any other elements changed from the
  original application

19
Communication in REACH
Tools Safety Data Sheets Art. 30
information Exposure scenario, ES
Actors in the supply chain
20
Communication in REACH

• Safety Data Sheet - Applies to dangerous
  substances
• The supplier shall provide the recipient with a
  SDS
• Any actors required to prepare a CSR shall place
  the ES in an annex to the SDS
• Any DU shall include relevant ES and other
  information supplied to him in his own
  preparation of a SDS

• Art. 30 information - Duty for which a SDS is not
  required
• Whether the substance is subject to authorisation
• Details on any restriction
• Any information if necessary to enable
  appropriate risk management measures resulting
  from the application of exposure based waiving

21
Communication in REACH
Communicate and fulfill exposure scenarios
Relevant for substances classified as dangerous
produced or imported in amounts of 10 tonnes or
more per year per producer/importer
By exposure scenario means The set of conditions
that describes how the substance is manufactured
or used during its life-circle and how the
manufacturer or importer controls, or recommends
downstream users to control, exposures of humans
and the environment.
22
Downstream users

• Chemical safety assessment and preparation of
  chemical safety report
• The DU shall make a CSA and a CSR if
• Non supported uses
• Uses outside the conditions given in the ES
• The assessment shall cover the life-cycle from
  the DU receives the substances, his own use and
  uses identified further down the supply chain.

DU shall notify the Agency of his uses of
substances within an authorisation
23
What is the impact?

• Know all your chemicals
• Know all your chemical uses
• Be ready to share data
• Know your supply chain
• Communicate with your supply chain
• Be proactive and innovative

24
Thank you!
You better be prepared!