REACH, SDS and CLP EU REGULATIONS ON CHEMICALS · Legal or natural person 2. Distributor / Importer...

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

www.ecomundo.eu

Thank you for

your attention!

mroussel@ecomundo.ca

+1 778 231 1607