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What is REACH
Regulation (EC) No 1907/2006
Effective Date: 1 June 2007 (Progressive schedule)
Registration
Evaluation
Authorisation &
restriction of
CHemicals
+ Pre-registration
+ Notification
2
Designed to protect human health and
the environment
Overview of EU REACH Regulation
What does it stand for?
Purpose
R egistration, E valuation, A uthorisation,
and restriction of CH emicals
REACH is about knowing what substances are
in products and their impact on human health
and the environment
Staggered process over 11 years which involves the
Registration, Evaluation, Notification,Authorizations
and Restriction of Chemicals (REACH)
Timeline
In Essence
3
European Chemicals Agency
Annankatu 18, P.O. Box 400, FI-00121
Helsinki, Finland
4
SVHC lists are published 2x per year
First SVHC Candidate List published Oct. 2008
5
• Registration, Evaluation, Authorization and Restriction
of Chemicals (REACH) is a European Union Regulation.
REACH addresses the production and use of chemical
substances, and their potential impacts on both human
health and the environment.
• REACH covers use of chemical substances of very high
concern (SVHC) because of their potential negative
impacts on human health or the environment.
• There are 223 SVHC up-to-date ( 17 Jan 2022)
• SVHC List are updated 2X every year
What is REACH?
6
7
eg;can cause cancerous tumors, birth defects, and other developmental
disorders.
A chemical may be in a product, but to be exposed, the
consumer must come into contact with the chemical.
How are you exposed to the following components?
How SVHC Exposed to Human Being?
8
• Evaluate articles that contain substances of very
high concern >0.1% by weight and totaling >1
ton/year
• If the level of SVHC is at a higher level than 0.1%
w/w then you have a duty to supply the recipient
with sufficient information to allow safe use of that
article.
• If the level SVHC is at a higher level than 0.1w/w
and it can be “intentionally” released and present
in the article or preparation at greater than 1 tonne
per annum, then the ECHA will need to be notified
and the SVHC will need to be registered.
What is REACH Compliance?
9
What is the Reach registration number?
A REACH registration number is an 18-
digit number assigned by the European
Chemicals Agency (ECHA). It is the most
straightforward proof that one company has
fulfilled their registration obligation for a
substance under the EU REACH
regulation.
REACH Number
10
CAS Registry Number, also referred to as CASRN or CAS Number, is
a unique numerical identifier assigned by the Chemical Abstracts
Service (CAS) to every chemical substance described in the open
scientific literature (currently including all substances described from 1957
through the present, plus some substances from the early or mid 1900s),
including organic and inorganic compounds, minerals, isotopes, alloys an
d nonstructurable materials (UVCBs, of unknown, variable composition,
or biological origin).
The registry maintained by CAS is an authoritative collection of disclosed
chemical substance information. It currently identifies more than 141
million unique organic and inorganic substances and 67 million protein
and DNA sequences, plus additional information about each substance. It
is updated with around 15,000 additional new substances daily.
CASRN
11
A CAS (Chemical Abstracts Service)
Registry Number is a unique identifier that
tells you, for example, that acetone and
dimethyl ketone are actually the same
substance. From a safety and inventory
perspective, this is a very important input.
CASRN
12
13
14
What is changing: Label Requirements
New Signal Words
“Warning” – less severe hazard
“Danger” – more severe hazard
Standardized Hazard Statements
Examples – “Highly flammable liquid and vapor”, “Causes skin
irritation”
Standardized Precautionary Statements
Examples – “Wear protective gloves”, “Do not breathe vapors”
Pictograms
Global Harmonized System
(GHS)
17
New Style Label
Signal Word
Danger
New Labels
Hazard Statements:
Highly flammable liquid
and vapor
May cause liver and
kidney damage
New Labels
New Labels
Relationships between
Label and SDS
Relationships between
Label and SDS
Relationships between
Label and SDS
25
26
27
The Safety Data Sheet (SDS)
REACH defines
• When a SDS must be provided
• What to do when you receive a SDS
• What a SDS should contain
• What is the format of a SDS
• When exposure scenarios should be annexed
• Classification and labelling information must be
provided in accordance with the CLP Regulation
• For mixtures, a transition period to CLP from previous
legislation applies until June 2015 (with provisions for
mixtures ‘on the shelf’ until June 2017)
28
When to expect a Safety Data Sheet (SDS)
When
substance or
mixture is
hazardous
• Substance or mixture is classified as hazardous
• Substance is PBT/vPvB
• Substance is on Candidate List
• Non-classified mixture contains certain
substances above specified limits (on request)
It is sold to
downstream
user(s)
• SDS are not required for the general public
• Sufficient information for safe use must be provided
Or it has
been
requested
• If a substance or mixture is sold
to both downstream users and
general public, SDS need not be
supplied, unless requested by
downstream user or distributor
29
When to expect an exposure scenario (ES)
When it is a
substance
• Exposure scenarios are included as an annex
to safety data sheet for substances.
• For mixtures, the supplier may communicate the
information from exposure scenarios for ingredient
substances in a number of ways
And
registered >
10
tonnes/year
• The substance is registered, and a chemical
safety assessment is required on registration
because the quantity manufactured or
imported by the registrant, exceeds 10 tonnes
per year
And it is
hazardous
• The substance is
classified as
hazardous or is
PBT/vPvB
30
What to do when you receive an
extended Safety Data Sheet (SDS+ES)
Apply
appropriate
measures
from SDS
• The main information relating to risk
management is in Sections 7,8 and 9
of the SDS and in Section 3 of the ES
Check your
use is
covered in
the ES
• Your use should be included and your
conditions of use should match those in
the exposure scenario from your supplier
Implement
ES conditions
of use
• Otherwise, contact or
change your supplier to
have your use covered,
or take alternative action
31
Obligations for downstream users who
supply substances and mixtures
• Classify, label and package substances
and mixtures in accordance with CLP
before placing them on the market
• Derive the classification of the mixture,
if formulating or changing the composition
of a mixture
• Classify the ingredient substances
according to CLP and notify the C&L
Inventory when importing a hazardous
mixture (if they contribute to the
classification of the mixture)
• Provide safety data sheet, exposure
scenarios or other information as specified
in REACH Title IV
• Recommend relevant risk reduction
measures to their customers
32
SDS Sections
• Section 1- Identification
• Section 2- Hazard(s) Identification
• Section 3- Composition/Information
Ingredients
• Section 4- First-Aid Measures
• Section 5- Fire-Fighting Measures
• Section 6- Accidental Release Measures
• Section 7- Handling and Storage
• Section 8-Exposure Controls/Personal
Protective Equipment
• Section 9- Physical and Chemical
Properties
• Section 10- Stability and Reactivity
• Section 11- Toxicological Information
• Section 12- Ecological Information (non-
mandatory)
• Section 13- Disposal Considerations (non-
mandatory)
• Section 14- Transportation Information
(non-mandatory)
• Section 15- Regulatory Information (non-
mandatory)
• Section 16- Other Information
34
35

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Overview -REACH Trng.pptx

  • 1. 1
  • 2. What is REACH Regulation (EC) No 1907/2006 Effective Date: 1 June 2007 (Progressive schedule) Registration Evaluation Authorisation & restriction of CHemicals + Pre-registration + Notification 2
  • 3. Designed to protect human health and the environment Overview of EU REACH Regulation What does it stand for? Purpose R egistration, E valuation, A uthorisation, and restriction of CH emicals REACH is about knowing what substances are in products and their impact on human health and the environment Staggered process over 11 years which involves the Registration, Evaluation, Notification,Authorizations and Restriction of Chemicals (REACH) Timeline In Essence 3
  • 4. European Chemicals Agency Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland 4
  • 5. SVHC lists are published 2x per year First SVHC Candidate List published Oct. 2008 5
  • 6. • Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) is a European Union Regulation. REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. • REACH covers use of chemical substances of very high concern (SVHC) because of their potential negative impacts on human health or the environment. • There are 223 SVHC up-to-date ( 17 Jan 2022) • SVHC List are updated 2X every year What is REACH? 6
  • 7. 7 eg;can cause cancerous tumors, birth defects, and other developmental disorders.
  • 8. A chemical may be in a product, but to be exposed, the consumer must come into contact with the chemical. How are you exposed to the following components? How SVHC Exposed to Human Being? 8
  • 9. • Evaluate articles that contain substances of very high concern >0.1% by weight and totaling >1 ton/year • If the level of SVHC is at a higher level than 0.1% w/w then you have a duty to supply the recipient with sufficient information to allow safe use of that article. • If the level SVHC is at a higher level than 0.1w/w and it can be “intentionally” released and present in the article or preparation at greater than 1 tonne per annum, then the ECHA will need to be notified and the SVHC will need to be registered. What is REACH Compliance? 9
  • 10. What is the Reach registration number? A REACH registration number is an 18- digit number assigned by the European Chemicals Agency (ECHA). It is the most straightforward proof that one company has fulfilled their registration obligation for a substance under the EU REACH regulation. REACH Number 10
  • 11. CAS Registry Number, also referred to as CASRN or CAS Number, is a unique numerical identifier assigned by the Chemical Abstracts Service (CAS) to every chemical substance described in the open scientific literature (currently including all substances described from 1957 through the present, plus some substances from the early or mid 1900s), including organic and inorganic compounds, minerals, isotopes, alloys an d nonstructurable materials (UVCBs, of unknown, variable composition, or biological origin). The registry maintained by CAS is an authoritative collection of disclosed chemical substance information. It currently identifies more than 141 million unique organic and inorganic substances and 67 million protein and DNA sequences, plus additional information about each substance. It is updated with around 15,000 additional new substances daily. CASRN 11
  • 12. A CAS (Chemical Abstracts Service) Registry Number is a unique identifier that tells you, for example, that acetone and dimethyl ketone are actually the same substance. From a safety and inventory perspective, this is a very important input. CASRN 12
  • 13. 13
  • 14. 14
  • 15.
  • 16. What is changing: Label Requirements New Signal Words “Warning” – less severe hazard “Danger” – more severe hazard Standardized Hazard Statements Examples – “Highly flammable liquid and vapor”, “Causes skin irritation” Standardized Precautionary Statements Examples – “Wear protective gloves”, “Do not breathe vapors” Pictograms Global Harmonized System (GHS)
  • 17. 17
  • 20. Hazard Statements: Highly flammable liquid and vapor May cause liver and kidney damage New Labels
  • 25. 25
  • 26. 26
  • 27. 27
  • 28. The Safety Data Sheet (SDS) REACH defines • When a SDS must be provided • What to do when you receive a SDS • What a SDS should contain • What is the format of a SDS • When exposure scenarios should be annexed • Classification and labelling information must be provided in accordance with the CLP Regulation • For mixtures, a transition period to CLP from previous legislation applies until June 2015 (with provisions for mixtures ‘on the shelf’ until June 2017) 28
  • 29. When to expect a Safety Data Sheet (SDS) When substance or mixture is hazardous • Substance or mixture is classified as hazardous • Substance is PBT/vPvB • Substance is on Candidate List • Non-classified mixture contains certain substances above specified limits (on request) It is sold to downstream user(s) • SDS are not required for the general public • Sufficient information for safe use must be provided Or it has been requested • If a substance or mixture is sold to both downstream users and general public, SDS need not be supplied, unless requested by downstream user or distributor 29
  • 30. When to expect an exposure scenario (ES) When it is a substance • Exposure scenarios are included as an annex to safety data sheet for substances. • For mixtures, the supplier may communicate the information from exposure scenarios for ingredient substances in a number of ways And registered > 10 tonnes/year • The substance is registered, and a chemical safety assessment is required on registration because the quantity manufactured or imported by the registrant, exceeds 10 tonnes per year And it is hazardous • The substance is classified as hazardous or is PBT/vPvB 30
  • 31. What to do when you receive an extended Safety Data Sheet (SDS+ES) Apply appropriate measures from SDS • The main information relating to risk management is in Sections 7,8 and 9 of the SDS and in Section 3 of the ES Check your use is covered in the ES • Your use should be included and your conditions of use should match those in the exposure scenario from your supplier Implement ES conditions of use • Otherwise, contact or change your supplier to have your use covered, or take alternative action 31
  • 32. Obligations for downstream users who supply substances and mixtures • Classify, label and package substances and mixtures in accordance with CLP before placing them on the market • Derive the classification of the mixture, if formulating or changing the composition of a mixture • Classify the ingredient substances according to CLP and notify the C&L Inventory when importing a hazardous mixture (if they contribute to the classification of the mixture) • Provide safety data sheet, exposure scenarios or other information as specified in REACH Title IV • Recommend relevant risk reduction measures to their customers 32
  • 33. SDS Sections • Section 1- Identification • Section 2- Hazard(s) Identification • Section 3- Composition/Information Ingredients • Section 4- First-Aid Measures • Section 5- Fire-Fighting Measures • Section 6- Accidental Release Measures • Section 7- Handling and Storage • Section 8-Exposure Controls/Personal Protective Equipment • Section 9- Physical and Chemical Properties • Section 10- Stability and Reactivity • Section 11- Toxicological Information • Section 12- Ecological Information (non- mandatory) • Section 13- Disposal Considerations (non- mandatory) • Section 14- Transportation Information (non-mandatory) • Section 15- Regulatory Information (non- mandatory) • Section 16- Other Information
  • 34. 34
  • 35. 35