REACH, SDS and CLP
EU REGULATIONS ON CHEMICALS
Everything you need to know!
SCC Ontario – March 25th, 2014
Marie Roussel & Ariane Divetain
Introduction to EcoMundo
Regulatory expertise
European
Research
Projects
EcoMundo
is
launched
Toxicology &
Ecotoxicology
Specialist
of EU
Chemical
Regulations
Software & Database
2001
2014
2007
Multidisciplinary team
Recognition
30 engineers of which
5 PhDs for expert services
US & Ca nadian Governments
Export.gov + Canadainternational.gc.ca
International presence
2009
Brussels office
European Commission
contact
2012
Vancouver office
Contact with North American clients
2007
Paris office
Headquarters
Overview of the presentation
Substance
Raw
material
1
Article
Mixture
Finished
formula
REACH Registration
3
SDS
4
CLP Regulation
2
SVHC
New Cosmetic Regulation 1223/2009
European Economic Area
European Union (28 countries)
+
Norway + Iceland + Liechtenstein
=
31 countries
concerned with
the REACH Regulation
List of concerned countries
In alphabetical order:
1. Austria
2. Belgium
3. Bulgaria
4. Croatia
5. Cyprus
6. Czech Republic
7. Denmark
8. Estonia
9. Finland
10. France
11. Germany
12. Greece
13. Hungary
14. Iceland
15. Ireland
16. Italy
17. Latvia
18. Liechtenstein
19. Lithuania
20. Luxembourg
21. Malta
22. Netherlands
23. Norway
24. Poland
25. Portugal
26. Romania
27. Slovakia
28. Slovenia
29. Spain
30. Sweden
31. United Kingdom
THE REACH REGULATION
REACH
11
REACH Registration
2
SVHC
Before REACH: the chaos!
FOURTY
DIRECTIVES
COMPLEXITY
A different interpretation
for each country
2007
ONE SINGLE
REGULATION
HARMONIZATION
Common obligations
to all 31 countries
REACH stands for…
Of chemicals substances > 1 MT per year
to gather data
R egistration
E valuation
Dossier verification by ECHA
Risk assessment for each substance
A uthorization
SVHC listed in Annex XIV. Ban except
if special permission is given.
and Restriction of
Ch emicals
Complete ban on
uses that pose
unacceptable risks
Key principles of REACH
1
2
3
No data, No market
No business without key data registration:
impacts, safe use, risk assessment, etc.
Precautionary Principle
Chemical products are considered as suspect until the
industry proves otherwise
Communication in the supply chain
Data sharing is essential between companies
What must be registered?
1
REACH
Chemical substances placed on
the EU market > 1 MT per year
The chemical to be registered can be found:
As a substance
on its own
In a raw
Material
In a finished
formula
Above 1 metric tonne p/y
1
REACH
How to calculate the tonnage?
> 1 MT p/y
> 1 MT p/y
Three-year rolling average
of the annual tonnage
Per legal entity in Europe
The three tonnage bands
1
REACH
Registration deadlines based on tonnages and dangers:
2010
> 1,000 tonnes
CMR > 1 t and R50/53 > 100 t
2013
100 to 1,000 tonnes
2018
From 1 to 100 tonnes
Who must register?
1
The EU importer
faces the obligation
However, for BUSINESS reasons,
non-EU companies can register too!
ONLY
REPRESENTATIVE
(OR)
REACH
1
Case scenario #1
REACH
You export 1.5 MT overall, but 500 Kg to each EU client
500
Kg
A
B
500
Kg
C
500
Kg
 All is good!
D
1
Case scenario #2
REACH
You export 10 MT of a chemical to one EU client
10
MT
A
B >1-100
100 MT
MT
95
50
MT
AChange
Aisdesignates
covered
of tonnage
byOR
B for
toband
now
secure
forEU
B business
OR = more EU clients
1
REACH
Without OR, you can only export to compliant clients
A
Having an OR = competitive advantage
OR = strategy & safety
1
REACH
I export to a single distributor in Europe
A
With OR = more control on your supply chain
OR = total freedom
1
REACH
I appoint an Only Representative (OR) based in Europe
A
I can sell to anyone in Europe
I don’t sell to Europe!
1
My clients are Canadian and US companies only
A
B
Unless
B isB aappoints
Distributor…
Your
client
an OR
REACH
Who is the OR?
1
REACH
Canadian manufacturer
Who can be OR?
1. EU subsidiary
2. Distributor / Importer
3. Regulatory Expert
Must be based in Europe
Only Representative
Legal or natural person
1 chemical = 1 dossier
1
REACH
JOINT
DOSSIER
Lead
Registrant Other manufacturers
+
Your company
Your own data
All registrants of one chemical
= a SIEF group
MEMBER
DOSSIER
Content of the dossiers
Annexe VII
Technical
dossier
> 1 tpy
+
Chemical
Safety
Report
1.Hazards Assessment
> 10 tpy
3.Risk characterisation
2.Exposure Assessment
1
REACH
1
Required data
REACH
The manufacturer must provide to the OR
•
•
•
•
Name and address of EU clients
Identity and uses of the substances to be registered
Exact tonnages of past 3 years exported to Europe
Analytical studies required:
For organic substances
 IR = Infra-red
 UV = Ultra-Violet
 NMR = Nuclear Magnetic Resonance
 Chromatography
For inorganic substances
 X-Ray Diffraction (XRD)
 X-Ray Fluorescence (XRF)
 Atomic Absorption
Spectroscopy (AAS)
And description of methods used
1
Data requirements
Depend on the tonnage band
Physico-chemical
Toxicological
Ecotoxicological
Annex X
Annex IX
Annex VIII
Tox and Ecotox
• Specific rules
• Waiving strategy
• Annex IX, X : testing
proposals
Annex VII
1-10 T
REACH
What are the costs?
1
REACH
Letter of Access
Lead Registrant
or Consortia
Member dossier
Regulatory
Expert
Submission fees
Full envelop between $10,000 to $50,000 on average
Summary
1
REACH
1. Tonnage of export? Key registration date?
Under one tonne per year, you are not concerned
2. Supply chain situation?
Compliance of your clients
3. What are the costs?
Dossier, letter of access, submission fee to ECHA
4. Designate an Only Representative (OR)
He fulfils all your legal responsibilities
What is an SVHC substance?
2
SVHC
At least one of the following criteria:
•
•
•
•
CMR = Carcinogenic, Mutagenic or toxic to Reproduction
PBT = Persistent, Bioaccumulative and Toxic
vPvB = very Persistent and very Bioaccumulative
Equivalent danger = endocrine disruptors (example)
• better communication on SVHC
DOUBLE
OBJECTIVE • gradually ban them from the EU market
2
Lists of substances
About 140,000 chemicals
Candidate list: 151 substances
Annex XIV
22 substances
SVHC
Registration
• Traceability
• Communication
• Notification
Authorization
Watch: these lists are updated twice a year on average
Obligations for articles
REGISTRATION
2
SVHC
SVHC SUBSTANCES
Substances
released > 1 T
NOTIFICATION
ARTICLE
to ECHA
>1T
COMMUNICATION
AUTHORIZATION
Substances
in Annex XIV
to Downstream users
> 0,1 % w/w
Communication >0,1% w/w
2
SVHC
3
1
2
Collect
SVHC data
from your
suppliers
Calculate
the %
(w/w) of
SVHC in
each
article
Information to communicate:
• Name of SVHC
• Rules to ensure safe use
Communicate
terms and
conditions of use
to clients
4
Following
consumer request,
you have 45 days
to answer
The 0.1 % w/w calculation
2
SVHC
Official rule: 0.1% applies to the entire article.
Buckle + leather
= 2 articles
But some countries consider each component as an article.
The calculation can vary from country to country!
Summary
2
1. Determine the presence of SVHC
Data collection from your suppliers
2. Assess the SVHC concentration
Calculation according to the countries
3. Above 0.1 % (w/w), check your obligations
Registration, Communication, Notification
4. Pay attention to updates of the Candidate list
Anticipate and subscribe to alerts
SVHC
SAFETY DATA SHEETS
REACH
13
SDS
3
The sections to follow closely
1 SDS is a passport
The
SDS
For industrial hazardous chemicals
SDS = main target in custom controls
Sanctions = fines, confiscations, ban to export / manufacture
3
The sections to follow closely
1
Specific
SDS obligations
SDS = mandatory if the substance or mixture is:
• classified as hazardous (according to CLP, DSD, DPD)
• classified as PBT or vPvB
• listed as an SVHC
SDS = must be translated
in the language of the export country
When the substance is REACH registered,
the SDS lists the registration number and covered uses
SDS
3
The sections to follow closely
1 in the supply chain
SDS
5.5
1.
Collect SDS from
your suppliers
3.
Send compliant SDS
to your clients in
their language for free
Supplier
A
YOUR
COMPANY
Supplier
B
SDS
2.
Keep SDS of
substances and mixtures
used on-site
Client
X
Client
Y
3
The sections to follow closely
1 mandatory sections
16
1. Identification of the
2.
3.
4.
5.
6.
7.
8.
substance/mixture and of
the company/undertaking
Hazard identification
Composition/information on
ingredients
First-aid measures
Fire-fighting measures
Accidental release measures
Handling and storage
Exposure controls/personal
protection
SDS
9. Physical and chemical properties
10. Stability and reactivity
11. Toxicological information
12. Ecological information
13. Disposal considerations
14. Transport information
15. Regulatory information
16. Other information
17. ANNEXES
extended SDS
when REACH registration
3
The sections to follow closely
1 your SDS compliant?
Is
SDS
Quick check-list before sending your SDS to Europe:
 Order of the 16 sections must be respected
 Date and version


Section 1: check the uses of your DU are covered
Section 2: classification according to CLP and DSD
 Translation is the right language
 Emergency call number (different for each EU country)
Summary
3
SDS
1. List hazardous substances + mixtures
Pay attention to updates of the SVHC list
2. Define their classification
According to CLP, DSD and DPD criteria
3. Update the format of your SDS + translate
According to REACH and CLP Regulations
4. Send your compliant SDS to clients
Only for your industrial clients
THE CLP REGULATION
REACH
14
CLP
Harmonization through CLP
4
CLP
Globally Harmonized System (GHS)
drafted by the United Nations
Previous directives
DSD = Substances
DPD = Mixtures
CLP Regulation
In force since 2009
• Classification
• Labelling
• Packaging
4
Deadlines
Classification DSD and CLP
Notification
Packaging
Labelling
June
2015 CLP
CLP
DPD or,
June
DPD and CLP 2015
CLP
to ECHA for substances > 1 MT and those classified
CLP only
June
DPD or CLP 2015
CLP
The 9 pictograms
4
CLP
Substance classification rules
4
CLP
• Reversible skin irritants effects at ≥ 5.0%
erythema/eschar, oedema, persisted
inflammation
Skin Irrit.2 : H315
• Effects on cornea, conjunctivae
(redness, oedema) but fully reverse
within 21 days at ≥ 5.0%
Eye Irrit.2 : H319
• Evidence in humans of skin sensitization
• Positive responses from in vivo tests
Skin Sens.1: H317
Mixture classification rules
4
CLP
2%
Skin Irrit.2 : H315
Eye Irrit.2 : H319
Skin Sens.1: H317
C ≥ 5.0 %
C ≥ 5.0 %
Skin Sens.1
H317
Labelling changes!
4
To comply, a label must include:
• name, address, phone number of the supplier
• nominal quantity of the substance
or mixture (general public)
• hazard pictograms, signal words,
hazard statements and
precautionary statements
CLP
Canada & USA
4
CLP
GHS has been adopted since 2012,
known as “HAZCOM 2012”. It will be
fully implemented in 2015.
US companies can thus anticipate.
Canada is preparing the amendment
of its Hazardous Products Act (HPA)
to be ready for 2015. Until then,
Canadian companies must comply
with the WHMIS standards.
Summary
4
CLP
1. List hazardous substances + mixtures
Caution : dates differ for substances and mixtures
2. Check the DSD / DPD / CLP classification
Pay attention to the date
3. Notify to ECHA, to the C&L inventory
Any substance above 1 MT (via your OR)
4. Change your labels and packaging accordingly
Use the new CLP pictograms
Thank you for
your attention!
mroussel@ecomundo.ca
+1 778 231 1607
www.ecomundo.eu