REACH and SDS Requirements Presented by Paula Laux Senior Regulatory Specialist Wercs Professional S

1
REACH and SDS RequirementsPresented by Paula
LauxSenior Regulatory SpecialistWercs
Professional Services
2
REACH and SDS Basics

• Regulation considers the SDS as key hazard and
  risk communication element
• Legal requirements based on adaptation of
  Globally Harmonized System for the Classification
  and Labeling of Dangerous Chemicals (GHS)
• Legal requirements may need further adaptation to
  comply after GHS is implemented

3
REACH and SDS Basics

• REACH regulation replaces the current SDS
  Directive (91/144/EEC)
• Current Responsibilities/duties for SDS remain,
  but are also extended.
• Nationally (each country in EU) will need
  separate national transposition of the SDS
  regulations which could lead to differences among
  member countries
• REACH will not have member state specific
  implementations

4
REACH and SDS Requirements

• Where a substance meets the criteria for
  classification as dangerous in accordance with
  Directives 67/548/EEC or 1999/45/EC, an SDS is
  needed
• If a Chemical Safety Assessment is part of the
  registration requirements, the SDS must be
  consistent with the assessment

5
REACH and SDS Requirements

• If the preparation does NOT meet criteria for a
  classification as dangerous, but gt 1 by weight
  for non-gaseous preparation and gt 0.2 by volume
  for gaseous preparation of at least one substance
  posing a health hazard, an SDS is needed
• If the preparation does NOT meet criteria for a
  classification as dangerous, but gt 1 by weight
  for non-gaseous preparation and gt 0.2 by volume
  for gaseous preparation of at least one substance
  for which there is a community workplace OEL, an
  SDS is needed
• If the downstream user requests an SDS.

6
REACH and duty to Communicate Information

• All substances placed on market regardless of
  hazard will require downstream Hazard
  Communication document
• The format and contents of the document will vary
  depending on whether the substance is meeting
  criteria for classification as dangerous and/or
  registered

7
REACH-Duty of Downstream User (DU)

• DU required to play active role in providing
  information up the supply chain on intrinsic
  properties.
• New information on hazardous properties
• Information that might call into question
  appropriateness of the risk management measures
  on the SDS.

8
REACH SDS Requirements

• Now that REACH is enacted there are different
  content SDS requirements for substance placed on
  market which meet criteria for classification as
  dangerous.

9
REACH and categories needing various SDS
Requirements

• SDS for substance out of scope of REACH (Article
  2) or substances registered under REACH (Slt 1
  t/y)
• SDS for substance subject to Registration
  requirements, but for which a CSA/CSR is not
  required (1-10 t/y)
• SDS for substances in the scope of REACH and
  subject to CSA/CSR

10
Best Source of Detailed Information

• Google REACH in BRIEF
• http//ec.europa.eu/enterprise/reach/docs/reach/re
  ach_in_brief_council_comm

11
When do you need an Extended SDS

• For Substances meeting criteria for
  classification as dangerous or PBT/vPvB
  substances manufactured or imported at gt10 t/yr
  which are placed on market
• For Substances gt100 t/y where testing proposal
  from technical dossier has been approved by
  competent authority and testing was completed--
  additional information will need to be
  incorporated into relevant sections of SDS
• For phase in substances the timescale by when the
  extSDS will be needed will be dependent on the
  deadlines for registrations governed by tonnages
  and classification

12
Responsibilities for ExtSDS

• Person at M/I or DU level responsible for adding
  additional informationif a CSR and extSDS is
  required
• ExtSDS must deliver information to DU in a form
  which allow him to check that his intended
  use/controls are in a form provided by upstream
  suppliers
• DU must consider if the Risk Management Measures
  on extSDS are relevant to his conditions of use
• DU must pass on relevant information to customer
  down supply chain

13
Extended SDS Requirements

• Specification of identified uses
• Derived No-Effect Level (DNEL)
• Predicted No-Effect Concentration (PNEC)
• Exposure Scenario
• Related Risk Management Measure
• Information on related waste disposal

14
Questions?