reach, sds and clp eu regulations on chemicals · legal or natural person 2. distributor / importer...
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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
2001 2007
European
Research
Projects
Multidisciplinary team 30 engineers of which
5 PhDs for expert services
2014
Specialist
of EU
Chemical
Regulations
Recognition US & Ca nadian Governments
Export.gov + Canadainternational.gc.ca
EcoMundo
is
launched
Regulatory expertise
Software & Database
Toxicology &
Ecotoxicology
International presence
Vancouver office Contact with North American clients
Brussels office European Commission
contact
Paris office Headquarters
2012 2007
2009
Overview of the presentation
Substance Mixture Article
SVHC
SDS
CLP Regulation
Raw
material Finished
formula
1
3
4
2
New Cosmetic Regulation 1223/2009
REACH Registration 1
European Economic Area
Norway + Iceland + Liechtenstein
European Union (28 countries)
+
= 31 countries
concerned with
the REACH Regulation
List of concerned countries
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
In alphabetical order: 21.Malta
22.Netherlands
23.Norway
24.Poland
25.Portugal
26.Romania
27.Slovakia
28.Slovenia
29.Spain
30.Sweden
31.United Kingdom
REACH
THE REACH REGULATION
SVHC 1 REACH Registration 1 2
Before REACH: the chaos!
COMPLEXITY
A different interpretation
for each country
HARMONIZATION
Common obligations
to all 31 countries
2007 FOURTY
DIRECTIVES
ONE SINGLE REGULATION
egistration Of chemicals substances > 1 MT per year
to gather data R
Ch
E
A
valuation
uthorization
and Restriction of
emicals
Dossier verification by ECHA
Risk assessment for each substance
SVHC listed in Annex XIV. Ban except
if special permission is given.
Complete ban on
uses that pose
unacceptable risks
REACH stands for…
No data, No market No business without key data registration: impacts, safe use, risk assessment, etc.
Communication in the supply chain Data sharing is essential between companies
Precautionary Principle Chemical products are considered as suspect until the
industry proves otherwise
Key principles of REACH
1
2
3
REACH 1 What must be registered?
Chemical substances placed on the EU market > 1 MT per year
In a finished
formula In a raw
Material
As a substance
on its own
The chemical to be registered can be found:
REACH 1 Above 1 metric tonne p/y
> 1 MT p/y Three-year rolling average of the annual tonnage
Per legal entity in Europe > 1 MT p/y
How to calculate the tonnage?
Registration deadlines based on tonnages and dangers:
> 1,000 tonnes
100 to 1,000 tonnes
CMR > 1 t and R50/53 > 100 t
2010
2013
2018
REACH 1 The three tonnage bands
From 1 to 100 tonnes
REACH 1 Who must register?
The EU importer faces the obligation
non-EU companies can register too! However, for BUSINESS reasons,
ONLY REPRESENTATIVE
(OR)
500 Kg
You export 1.5 MT overall, but 500 Kg to each EU client
REACH 1 Case scenario #1
B 500 Kg
C
500 Kg
D
All is good!
A B
B
10 MT
You export 10 MT of a chemical to one EU client
REACH 1 Case scenario #2
50 MT
A is covered by B for now
A B 1-100 MT
50 MT
B > 100 MT
10 MT
95 MT
Change of tonnage band for B
10 MT
B 1-100 MT
A designates OR to secure EU business
Without OR, you can only export to compliant clients
REACH 1 OR = more EU clients
Having an OR = competitive advantage
A
I export to a single distributor in Europe
REACH 1 OR = strategy & safety
A
With OR = more control on your supply chain
I appoint an Only Representative (OR) based in Europe
REACH 1 OR = total freedom
I can sell to anyone in Europe
A
My clients are Canadian and US companies only
REACH 1 I don’t sell to Europe!
A
Your client B appoints an OR
B
Unless B is a Distributor…
REACH 1 Who is the OR?
Canadian manufacturer
Only Representative
1. EU subsidiary
Must be based in Europe
Who can be OR?
Legal or natural person
2. Distributor / Importer
3. Regulatory Expert
REACH 1 1 chemical = 1 dossier
Lead
Registrant Other manufacturers
JOINT
DOSSIER
Your company
Your own data
MEMBER
DOSSIER
All registrants of one chemical
= a SIEF group
+
+
Annexe VII
1.Hazards Assessment
2.Exposure Assessment
3.Risk characterisation
REACH 1 Content of the dossiers
Technical
dossier
> 1 tpy
Chemical
Safety
Report
> 10 tpy
REACH 1 Required data
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:
IR = Infra-red
UV = Ultra-Violet
NMR = Nuclear Magnetic Resonance
Chromatography
And description of methods used
X-Ray Diffraction (XRD)
X-Ray Fluorescence (XRF)
Atomic Absorption
Spectroscopy (AAS)
For inorganic substances For organic substances
REACH 1 Data requirements
Depend on the tonnage band Annex X
Annex IX
Annex VIII
• Specific rules
• Waiving strategy
• Annex IX, X : testing proposals
Annex VII 1-10 T
Physico-chemical
Toxicological
Ecotoxicological
Tox and Ecotox
REACH 1 What are the costs?
Letter of Access Lead Registrant
or Consortia
Member dossier Regulatory
Expert
Submission fees
Full envelop between $10,000 to $50,000 on average
REACH 1 Summary
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
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)
DOUBLE OBJECTIVE
SVHC 2 What is an SVHC substance?
• better communication on SVHC
• gradually ban them from the EU market
About 140,000 chemicals
Annex XIV 22 substances
Candidate list: 151 substances
Registration
Authorization
• Traceability •Communication •Notification
SVHC 2 Lists of substances
Watch: these lists are updated twice a year on average
SVHC 2 Obligations for articles
REGISTRATION Substances
released > 1 T NOTIFICATION
to ECHA > 1 T
COMMUNICATION
to Downstream users > 0,1 % w/w AUTHORIZATION
Substances in Annex XIV
SVHC SUBSTANCES
ARTICLE
Collect SVHC data from your suppliers
1 Calculate
the % (w/w) of SVHC in
each article
2 Communicate
terms and conditions of use
to clients
3
Information to communicate: • Name of SVHC • Rules to ensure safe use
SVHC 2 Communication >0,1% w/w
Following consumer request, you have 45 days
to answer
4
Official rule: 0.1% applies to the entire article.
SVHC 2 The 0.1 % w/w calculation
The calculation can vary from country to country!
Buckle + leather = 2 articles
But some countries consider each component as an article.
SVHC 2 Summary
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
REACH
SAFETY DATA SHEETS
1 SDS 3
SDS = main target in custom controls
For industrial hazardous chemicals
1 The sections to follow closely SDS 3 The SDS is a passport
Sanctions = fines, confiscations, ban to export / manufacture
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
1 The sections to follow closely SDS 3 Specific SDS obligations
When the substance is REACH registered, the SDS lists the registration number and covered uses
5.5
3. Send compliant SDS
to your clients in their language for free
YOUR COMPANY
1. Collect SDS from
your suppliers
2.
Keep SDS of substances and mixtures
used on-site
Client X
Client Y
Supplier A
Supplier B
1 The sections to follow closely SDS 3 SDS in the supply chain
1
1. Identification of the substance/mixture and of the company/undertaking
2. Hazard identification
3. Composition/information on ingredients
4. First-aid measures
5. Fire-fighting measures
6. Accidental release measures
7. Handling and storage
8. Exposure controls/personal protection
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
1 The sections to follow closely SDS 3 16 mandatory sections
extended SDS when REACH registration
1 The sections to follow closely SDS 3 Is your SDS compliant?
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)
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
SDS 3 Summary
REACH
THE CLP REGULATION
1 CLP 4
CLP Regulation In force since 2009
DSD = Substances
DPD = Mixtures
CLP 4 Harmonization through CLP
Globally Harmonized System (GHS) drafted by the United Nations
• Classification
• Labelling
• Packaging
Previous directives
Classification
Notification
Packaging Labelling CLP CLP only
CLP 4 Deadlines
June 2015 DPD or CLP
CLP June 2015
DPD or, DPD and CLP CLP
June 2015
DSD and CLP
to ECHA for substances > 1 MT and those classified
CLP 4 The 9 pictograms
CLP 4 Substance classification rules
• Evidence in humans of skin sensitization • Positive responses from in vivo tests
Skin Irrit.2 : H315
Eye Irrit.2 : H319
Skin Sens.1: H317
• Effects on cornea, conjunctivae (redness, oedema) but fully reverse within 21 days at ≥ 5.0%
• Reversible skin irritants effects at ≥ 5.0% erythema/eschar, oedema, persisted inflammation
CLP 4 Mixture classification rules
Skin Irrit.2 : H315
Eye Irrit.2 : H319
Skin Sens.1: H317
C ≥ 5.0 %
C ≥ 5.0 %
Skin Sens.1 H317
2%
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 4 Labelling changes!
GHS has been adopted since 2012, known as “HAZCOM 2012”. It will be fully implemented in 2015. US companies can thus anticipate.
CLP 4 Canada & USA
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.
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
CLP 4 Summary
