Chemical Watch EXPO · Chemical Watch EXPO Berlin, Germany, April 25 th–26 , 2017 Dr. Michael...

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Chemical Watch EXPOBerlin, Germany, April 25th – 26th, 2017

Dr. Michael Cleuvers, Managing Director Industrial Chemicals & Biocides

Integrating REACH compliance with global compliance

– Developments in East-Asia

ChinaKorea

Taiwan

Thailand

Malaysia

Philippines

Vietnam

Indonesia

Agenda

Introduction / Background

Types of legislations / Inventories

Data requirements

Brief examples, overview about

- China

- Korea

- Taiwan

- Thailand

GHS implementation

Summary

Political commitment on the goal to achieve:

«By 2020, chemicals are used and produced in ways

that lead to the minimization of significant adverse effects

on human health and the environment»

A look back:

World Summit on Sustainable Development

(WSSD), Johannesburg 2002

National policy development around the world

United Nations Environment Programme (UNEP):

framework for national chemical management

1. Information access, data availability

2. Policy and planning

3. Laws

4. Institutions

5. Implementation and enforcement capacities

6. Public participation

National policy development

Levels of national policy development:

Level 0: almost no capacity exists

Level 1: limited information available, needs identified, constitutional

resources exist, clear mandates for ministries,

Level 2: chemicals integrated in national policies, comprehensive

legislation exist

Level 3: all elements have been fulfilled (e.g. EU-REACH)

What do we need to get there?

Summary of recommendations (OECD)

• Increase cooperation and mutual acceptance of data

• Improve understanding of adverse effects of chemicals on individuals and populations and better quantify sources of exposure

• More preventative action to avoid harm from chemicals

• Promote sustainable use of chemicals

• Improve the public’s right to know

• Improve enforcement of regulations

Opportunities to share information

Huge amount of data is made publicly available on ECHA's website –accessible to other countries

International cooperation is expressly foreseen in REACH. ECHA has signed bilateral co-operation agreements with agencies in Canada, Australia, Japan, US

EU is engaged in (negotiations for) a range of bilateral agreements and dialogues that also concern chemicals (e.g. South Korea FTA, Japan, China)

EU is committed to multilateral work in OECD, UN

No obstacles in principle for information sharing – safeguards necessary for protection of CBI

The global perspective

Source: Cefic: The European chemical industry, Facts & Figures 2013,

Important initial questions to answer if you want

to sell your chemical products globally

What kind of regulation is existing in my target markets?- New chemicals, existing chemicals, hazardous chemicals?

Only chemical inventories to check?

Registration necessary? Different types? Exemptions?

Rules for Classification and labelling?

Data requirements? National specialities?

What is my REACH data package good for?

Starting position and initial considerations

What about….

Your substance?

Identity, composition, properties,

form in the supply chain

Your position in the supply chain?

Different obligations for different actors

Your needs and obligations?

Tonnage band, data requirements, uses

Your budget?

Different scenarios (short term / long term)

Scope of chemical management schemes

EU-REACH:

All chemicals (unless exempted) above 1 t/a (new and existing,

hazardous and non-hazardous)

Only new chemicals:

MEP Order No. 7 (China), TSCA (USA), NSN (Canada)…

Only hazardous chemicals (new and existing):

Decree 591/SAWS Order No. 53 (China), EHSNR (Malaysia)…

New chemicals and selected existing chemicals:

AREC (Korea), TCSCA (Taiwan)…

A company which develops a new substance and wants to

market it in several countries, has to follow different

legislations with different data requirements.

Additionally, as many countries have their own chemicals

inventories, often a substance is considered to be an

existing one in country „A“ but a new one in country

„B“, which may trigger unexpected requirements.

For example, needless to say that the Chinese IECSC is not

equivalent to EINECS !

Starting point

There are about 100.000 substances on EINECS, and

even 146.000 substances have been preregistered as

phase-in substances under REACH. However, only

about 45.000 substances are listed on the inventory of

existing chemical substances in China (IECSC).

All chemical substances not listed in Inventory of

Existing Chemical Substances in China (IECSC) are

new chemical substances and subject to notification!

While most commodities may be listed on IECSC, many

other substances may be identified as new substances,

especially specialty chemicals or high tech products

imported from western countries.

EINECS vs IECSC

This is of particular importance because manufacturers

and/or importers of new substances have to submit new

substances notification before these substances are

offered on the market and there are strict penalties

imposed for non compliance.

In China alone there is room for thousands of

misconceptions! Thus, it is very important to check all

relevant inventories.

Chinese inventory (IECSC)

Matrix for relevant inventories

Substance EU China Korea Japan

A Listed Listed Listed Listed

B Listed Not listed Listed Not listed

C Listed Not listed Not listed Listed

D Not listed Not listed Not listed Not listed

E Listed Listed Listed Listed

When determining the data requirements, it may come

out that you have to perform even more than one test per

endpoint (e.g. fish, biodegradation) or additional studies

(repeated dose) compared to REACh depending on the

target market.

Find out in time what are the data gaps and what is the

most critical endpoint with regards to costs and timing.

Data requirements

If you have purchased a REACH Letter of Access: are

you allowed to use the data also for other regulations

outside of REACH?

Is the legal entity who is exporting to Non-EU the same

who has purchased the LoA under REACH?

Data gap analysis

Endpoint (selected) EU

A. VII

Low V.

Fish, acute (OECD 203) No No Yes No

Fish acute China (OECD 203, local) No Yes No No

Biodegradation (OECD 301) Yes No Yes No

Biod. Japan (OECD 301C) No No No Yes

Biod. China (OECD 301, local) No Yes No No

Acute tox, oral (OECD 401, 423) Yes Yes Yes No

Acute tox, dermal (OECD 402, 434) No Yes No No

Repeated dose toxicity (OECD 407) No Yes No No

Matrix for Data requirements

Example: Tonnage band 1-10 t/a

Endpoint (selected) Existing

Waiver Read-

across,

Fish, acute (OECD 203) No No No Yes

Fish acute China (OECD 203, local) No No No Yes

Biodegradation (OECD 301) Yes - - -

Biod. Japan (OECD 301C) No No No Yes

Biod. China (OECD 301, local) No No No Yes

Acute tox, oral (OECD 401, 423) Yes - - -

Acute tox, dermal (OECD 402, 434) No No No Yes

Repeated dose toxicity (OECD 407) No No No Yes

Data gap analysis

Example: a REACh Annex VII data set

is available

Although you have a REACh Annex VII data set and

you are in the same tonnage band, there are additional

requirements to fulfill if you want to market your

substance in Asian markets.

Thus, consider this additional effort when you are

setting up your marketing & sales strategy (time &

money!)

Data gap analysis

What to do in the event that sales & marketing forecasts

exceed the originally approved notification level?

Additional data requirements due to a dossier

upgrade (tonnage band increase)

EU: post-exceedance

No need to interrupt the substance supply. Applicant

informs the authority, discusses and performs additional

testing and updates the dossier.

China, Japan: pre-exceedance

The supply is restricted to the notified tonnage band.

Applicant discusses and performs additional testing and

updates the dossier before he can increase the supply.

Data requirements – data acceptance

OECD: Mutual Acceptance of Data (MAD):„The testing of chemicals is labour-intensive and expensive. Often the

same chemical is being tested and assessed in several countries.

Because of the need to relieve some of this burden, the OECD Council

adopted a decision in 1981 stating that data generated in a Member

country in accordance with OECD Test Guidelines and Principles of

Good Laboratory Practice (GLP) shall be accepted in other Member

countries for assessment purposes and other uses relating to the

protection of human health and the environment“.

But some of your target markets may not be OECD

member states or have not yet implemented GLP

standards (or have other reasons to deviate from this

approach…).

Challenging…..but invest in sound planning - and you

are half way there

These new requirements will not „go away“….

„Wait and see“ or „hide“ ar not sustainable approaches…

Be active !

ChinaMEP Order No.7

Decree 591, SAWS Order No. 53

With support from Xiaohua He,

xhe@knoell.com

Chemical management in China

- Nie, 2012 (modified)

Existing chemicals (IECSC, 2013)

Not regulated

162 Toxic substances strictly controlled for import and

export (T-Catalogue, 2014)

MEP Administration Announcement 113 (2014)

84 Priority hazardous chemicals catalogue for

environment management (2014); MEP Order No. 22

(Trail, 2012)

Hazardous chemicals (HazChem Catalogue 2015)

SAWS Order No. 40, 41, 50, 51, 53 and 55 (2010-2012)

National standards for GHS implementation (GB 30000)

New chemical substances registration

MEP Order No. 7 (2010)

Check your duties

Your substance is

existing?

Check public and

confidential parts of

IECSC!

Your substance is a Restricted

Toxic Chemical for Import &

Export or listed as Hazardous

Chemicals

Your use requires

registration under

China-Reach?

No registration

obligationsImport Clearance

Notification,

Registration

Certificate

(SAWS Order

53), SDS, ..

Arrange new

substance

registration with

your legal

representative

Yes No

Check whether other

regulations may apply

(pesticides, pharmaceuticals, ..)

NoNo Yes

Notification types – new substances

Type of Notification Scope

Typical Notification

New chemical substances,

manufactured / imported > 1 t/a;

tonnage based notification levels:

1-10, 10-100, 100-1000, > 1000 t/a

Simplified Notification(basic conditions)

manufactured / imported < 1 t/a

Simplified Notification(specific conditions)

- for export only < 1 t/a

- for scientific research 0.1-1 t/a

- for technological research < 10 t/a

- for polymers

(if all monomers already listed in IECSC or

containing < 2% new chemicals)

- for low concern polymers

Scientific Research Record

for scientific research < 0.1 ton or for samples to

be tested in laboratories in China

Toxicology

Data Requirement

Level I

1-10 t/a

Level II

10-100 t/a

Level III

100-1000

Level IC

> 1000 t/a

Acute toxicity × × × ×

28-d repeated dose

toxicity

× × × ×

Mutagenicity × × × ×

90-d repeated dose

toxicity

× × ×

Reprod./developm.

Toxicity

× × ×

Toxicokinetics × × ×

Chronic toxicity ×

Carcinogenicity ×

Data RequirementLevel I

1-10 t/a

Level II

10-100 t/a

Level III

100-1000 t/a

Level IC

> 1000 t/a

Algal growth inhibition × × × ×

Daphnia acute × × × ×

Fish acute × × × ×

Activated sludge × × × ×

Adsorption/desorption × × × ×

(Bio-)degradability × × × ×

Earthworm acute × × × ×

Fish 14-d prolonged × × ×

Daphnia reproduction × × ×

Bioaccumulation × × ×

Fish chronic × ×

Terr. plants × ×

Ecotoxicology

Some Ecotox-data has to be generated in certified Chinese labs using

Chinese test species (e.g. for fish and invertebrate tests).

Data requirements

In Toxicology as well as in Ecotoxicology the Measures are more

demanding than REACh. There is no option to include testing proposals

first.

Testing Data are strongly preferred over other types

of data. QSARs and Read-Across are helpful for

screening purposes, but acceptance by authorities is

difficult. For literature data full reports need to be

provided (not only abstracts).

Expert Statements can be acceptable (case by case).

Testing in China

In China in some labs you can choose between „Chinese

GLP“ (cheaper) and OECD GLP.

If you want to use the studies outside of China, OECD

GLP is mandatory!

Check thoroughly whether you need a study for China

only or if you need it also for other jurisdictions.

Guidance for new chemical notification and registration

(issued end of October, 2016)

China’s Ministry of Environmental Protection (MEP) has submitted

the revised draft new substance guidance on MEP Order No. 7

(draft 2nd revised, 2016) to the World Trade Organization (WTO) in

May 2016.

Key revised points:

➢ Exemptions, Scope of application and Dissemination

➢ Registrant and certificate holder

➢ Data requirements and waiving conditions

➢ Polymer registration and notifcation

➢ Risk assessment report

➢ Changes or cancellation of certificate

South KoreaAct on the Registration and Evaluation

of Chemicals

With support from In Woo Kim,

ikim@knoell@com

REPORTING(Chemicals & Mixtures)

AuthorizationToxic substances

ASSESSMENT

HAZARD

EVALUATIONREGISTRATION

Existing substances ≥ 1MT/ y

New substances (all) Restriction/

Prohibition

Shall be registered before

manufacture/importation

Designated existing

substances ≥ 1 MT/y

or < 1 MT/y for highly

hazardous substances

Notification of Hazardous

Chemicals in Products

Publication of

Criteria of

Safety/Labeling

Risk Concerned

ProductsRisk Assessment

by MoE

PRODUCTS

K-REACH

If violated : Order of withdrawal

If no criteria : Submission of risk

data37

Obligations

Annual Reporting

▪ All new substances and existing substance of ≥1 t/a should be reported by 30th of June each year.

Registration of substances (new and Priority Existing Chemicals (PEC))

▪ Joint registration of PEC substances ≥ 1 t/a within 3 years of grace period (Currently 510 PEC substances by June 2018)

▪ All new substances before the manufacture/import

Product notification

▪ Products containing hazardous substance(s) over 0.1 % weight ratio per product and the total amount of the substance is more than 1 t/a.

Annual reporting

Reporting contents

▪ Substance name, CAS-No., tonnage band, use category

▪ Importer information

▪ Country of origin of the substance

Attachement

▪ OR appointment confirmation certificate

▪ by 30th of June each year

PEC substance registration – UNDER REVISIONDeadline for 1st batch: June 30th, 2018

Joint registration data requirement

▪ Classification & labelling

▪ Physicochemical properties

▪ Tox & EcoTox data

▪ Test plan (if necessary)

▪ Risk assessment (≥10 t/a)

▪ Guidance on safe use

Could be prepared per registrant

Join SIEFRegistration through K-REACh IT system

Registration confirmation

ImporterOnly Rep.

Import /manufacture

allowed

* Registration confirmation takes up to 30 days, however, in case of late registration (within 2

months before the deadline) it may take up to 3 months!

General data requirement

▪ Substance information (name, CAS-

No., purity, molecular formular,

product name, impurities/by-products)

▪ Tonnage

▪ All uses

▪ Product type and content

▪ Exposure information related to use

New substance registration

Request for registration check of the same substance*

RegistrationImporter

Only Rep.

Import /manufacture

allowed

* In case there was a registration of the same substance, data-sharing for phys-chem and Tox

& EcoTox can be requested.

Registration confirmation

New substances must be registered before manufacture / import.

Currently low-volume substances (<1 t/a) benefit from data exemption

▪ Data exemption: No Phys-chem data, Tox & EcoTox data, risk assessment, guidance on safe use

▪ Exempted data should be submitted if available

▪ From 2020 data exemption will be applicable only to new substances ≤ 0.1 t/a

Content

▪ Consumer products containing hazardous substance(s) > 0.1% in weight ratio and > 1 t/a in total amount.

▪ Consumers regard to such individuals using the products for consumption or production activities, however, in case they use the products as raw materials to produce another product, the definition of consumer does not apply.

▪ The substance is subject to notification along with information on the products.

▪ Before manufacture / import after exceeding the total amount of 1 t that year

“A product means a mixture or an article used by an end user or a component of

the mixture or the article that may expose consumers to chemical substances”.

Check if on

Flowchart – products imported into Korea

List of components in your

products imported to Korea

New chemical

substance

(registration is required)

510 PECs

list, if on the

list: registration

is required

Check if

hazardous or not

No product

notification needed

Contained in

the product

0,1 % and

> 1 t/year ? to be notified by

manufacturer/importer to

local MoE office!

No product notification

needed

Future amendments to K-REACH

Major changes ahead!

Annual Reporting

▪ is to be abolished – speculated to enter in force from 2018.

Registration of ALL EXISTING substances (more similar to EU REACH)

▪ Introduction of pre-registration for all existing substances > 1t/a

▪ Registration deadline depends on the tonnage

▪ Biocidal products are to be regulated under a separate regulation (similar to EU BPR)

TAIWANToxic chemical substances control act

With support from Xiaohua He,

xhe@knoell.com

Two Regulations:

Toxic Chemical Substance Control Act in Taiwan

• Regulation of New and Existing Chemical Substances Registration

Law/Act Toxic Chemical Substances Control Act (TCSCA)

Authority Taiwan’s Environmental Protection Administration (Taiwan EPA)

Implementation date 11 December 2014

• Regulation of New Chemical Substance Registration and Management

Law/Act Occupational Safety and Health Act (OSHA)

Authority Taiwan’s Ministry of Labor (Taiwan MOL)

Implementation date 01 January 2015

English version of the Regulation of New and Existing Chemical Substances Registration

available under: http://law.moj.gov.tw/Eng/LawClass/LawContent.aspx?PCODE=O0060043

New Chemical Substance (NCS) — Notification Basics

• Who: - Domestic (Taiwanese) entities, who manufacture or import.

- Companies with no legal entity in Taiwan can apply for

chemical substance registration but must do so through a

Taiwan-based “agent” (third-party). No Only Representative.

• What: Substances not on Inventory or not otherwise excluded

• When: Since 11 December 2014; 90 days prior to manufacture and

import

• How: Via three types of notification:

Standard Registration, hazard & exposure assessments

may also be requested

Simplified Registration

Small Quantity Registration

Submission via one joint portal of TCSCA and OSHA now

possible.

TCSCA/OSHA

New Chemical Substance (NCS) — Registration types

MT/yrPolymer of

Low Concern0

Substance

for SRD1

On-site Isolated Intermediate;

Polymer; Substance for PPORD2

Regular

NCSCMR3

No Requirements Small Quantity Registration

Small Quantity RegistrationStandard Registration

(Level I)0.1 Simplified Registration

Quantity

Registration

Simplified RegistrationStandard Registration

(Level I)

Standard Registration

(Level II) ++4

(Level I)

(Level II) ++

(Level III) ++

100Standard Registration

(Level III) ++Standard Registration

(Level IV) ++1000

(Level IV) ++

0 Polymer of low concern: Status needs to be evaluated and verified by Central Competent Authority.1 SRD: Scientific Research and Development.2 PPORD: Product and Process Orientated Research and Development.3 CMR: Substance, which is Carcinogenic, Mutagenic or Toxic to Reproduction.4 ++: Plus Hazard Assessment and Exposure Assessment.

Registration of existing substances

Phase I Registration

- Like a pre-registration under EU REACH. Only company and contact

info, substance identification, quantity, and info on manufacture and

uses has to be provided.

Phase II: Registration of Existing Substances - Standard Registration

- EPA will announce the list of designated existing substances subject to

standard registration in 4 batches.

- Each batch will be given a grace period of 2-3 years.

- The first batch was expected to be announced in 2016, but this has

been postponed to December 31st, 2017!

- Data requirement is the same as standard registration of new

substances.

THAILANDHazardous Substance Act B.E. 2535 (1992)

With support from P. Pukclai,

ppukclai@knoell.com

Current Regulation: Hazardous Substance Act B.E. 2535

(1992)

Proposed Changes 2017 and Beyond

1st issued in B.E. 2535 (1992), revised twice in B.E. 2544 (2001) and B.E. 2551 (2008)

Under the responsibility of the Ministry of Industry (MOI)

Diverse characteristics & usages of substances, enforcement is split over 6 authorities:

Department of Agriculture (DOA), Ministry of Agriculture and Cooperatives (MOAC)

Department of Fisheries (DOF), MOAC

Department of Livestock Development (DLD), MOAC

Food and Drug Administration (FDA), Ministry of Public Health (MOPH)

Department of Industrial Works (DIW), MOI

Department of Energy Business (DOEB), Ministry of Energy (ENERGY)

Hazardous Substance Act B.E. 2535 (1992)

Hazardous Substances List B.E. 2556 (2013) and B.E. 2558 (2015)

Annex Responsible

Authority

Sub-List Number

1 DOA 1.1 Discrete Substances

1.2 Groups and classes by “properties” or uses e.g., “Active

ingredients…intended for preventing, destroying or

controlling plant diseases”

2 DOF 2.1 Discrete Substances

2.2 Groups

2.3 Classes by “properties” or uses

3 DLD 3.1 Discrete Substances

3.2 Groups and classes by “properties” or uses

4 FDA 4.1 Discrete Substances

4.2 Groups

4.3 Classes by “properties” or uses

5 DIW 5.1 Discrete Substances

5.2 Chemical Wastes

5.3 Used Electrical Equipment and Appliances

5.4 Others

5.5 Chemical Weapons

5.6 Substances and mixtures based on hazard

properties*

6 DOEB Natural Gas and Liquefied Petroleum Gas 253

All producers, importers, carriers and persons in possession of listed HS must notify, register

or submit application of a license at the Hazardous Substances Control Bureau, DIW.

HS Type 1

Notification of product information

HS Type 2 & 3 (Registration and Licensing (Type 3)

Check status of substance via online system and discuss with DIW authorities

Submission of application and related documents: 100% composition, MSDS, etc.

Checking of application and its dossiers by DIW officers

Evaluation process

Approval from the authorized officer

Issuance of registration certificate

HS Type 4

Totally banned

For the official DIW guideline, go to: http://php.diw.go.th/haz/?page_id=286

Notification, Registration & Licensing Procedures

New list 5.6

On Feb 19th, 2015, Ministry of Industry (MOI) published a notification pertaining to

the List of Hazardous Substances (No. 2) B.E. 2558 (2015).

According to the notification, manufacturers and importers of chemical substances

that meet certain criteria will have to notify chemical substances to the Department

of Industrial Works (DIW).

By gathering notification information, DIW aims to prepare Thailand’s inventory of

existing chemicals and determine the appropriate approaches for chemicals

management in Thailand.

Notifications should be submitted within 60 days from the date of manufacture or

importation of any listed hazardous materials that exceed a designated quantity

threshold.

Once notified, the substances will be added into a new Annex (Annex 5.6) of the

current list of hazardous substances.

Current Management

Existing Chemicals

Current Management of Existing Chemicals

Online consultation is usually the first step to evaluate theregistration status of the ingredients of the product

If any ingredient of a product is not yet regulated, a notification is necessary:

Submission of Notification-Dossier (product composition,manufacturing process, Certificate of Free Sale, label, MSDS, toxicitydata, use, analytical method,…)

Decision about whether substance is hazardous and which of thegovernment agencies will be assigned as responsible

New Chemicals (not yet controlled as Type 1-4)

Current Management of Existing Chemicals

HS List 5.6:

Controlled Substances based on Hazard Properties

No. Hazard Properties

1 Explosive

2 Flammable substance

3 Oxidizing agent or Peroxide

4 Toxic Substance

5 Mutagen

6 Corrosive

7. Irritant

8. Carcinogen

9. Toxic substance to

reproductive organ

10. Environmentally hazardous

substance

Hazardous Substance under

the condition “…only

substances or mixtures not

having responsible agency for

production or import. They

shall be compiled with criteria

and method prescribed by

MOI…”

Notification to list 5.6

Notification to Department of Industrial Works (DIW) via the online system

Once within 60 days from the date of manufacture or import

Only required for hazardous substances listed in annex 5.6

Information required:• Legal entity

• Type of activity: production or import;

• Type of hazardous substances: substance or mixture

• Trade name and HS code

• Transport information: UN number, class

• Composition

• Type of packaging

• Manufacturer name and country of origin

• GHS classification

• Physico-chemical properties, toxicological, ecotox and disposal information (from SDS)

• Copy of GHS SDS prepared in Thai or English

https://www.jetro.go.jp/ext_images/thailand/pdf/29MOI_Noti_Declare_hazard_substance_list_5_6_B.E._2558.pdf61

Preliminary Inventory

DIW published the Preliminary Inventory on 6th August 2016

(http://diw-test3.diw.go.th:8077/) technical difficulties (use

Chrome-browser, offline from time to time)

http://haz3.diw.go.th/invhaz/

http://www.chemsafetypro.com/Topics/Thailand/Thailand_Hazardous_Substances_List.h

It so far contains only hazardous substances which were notified/

registered to DIW between 2012-2015.

Non-Hazardous Substances are expected to be included later

Language mainly only in Thai

Even if chemicals are listed, notification/registration of products

is still required

Search by CAS RN or Trade Name

Online Draft Inventory

Formaldehyde

Proposed Plan for Additional Management

Not too many details available yet

Expected implementation from 2017 onwards

Biggest change to be expected is implementation of Risk

Assessment for SVHC and hazardous substances not included on

the inventory.

Unclear when and how the Risk Assessment will be implemented

Submit Notification Dossier to include product composition, manufacturing process,label, MSDS, toxicity data, use, analytical methods…

Hazardous status and the assignment of the relevant regulating Ministry to bemade by the Authority

New substances that are not hazardous or do not meet Substance of Very HighConcern criteria will qualify for a simplified risk assessment report. SVHC criteria:

• Production/import volume >=10 MT/year

• CMR category 1A/1B

• PBT/vPvB

• Substances of equivalent concern or included in international conventions

For hazardous substances notification of production/import volume willcontinue to be required when the volume is >1MT/year. Registration and/orLicense may also be required depending on hazard

Proposed New Substance Notification Process

Requirements for existing hazardous substances will remain (e.g., notification ofproduction/import volume, registration and licenses based on hazard types), but inaddition the substances will be screened to determine if further action is warranted

SVHC criteria will be used to prioritize substances for screening

Substances determined to be SVHC will require a risk assessment report.Deadlines for submission will vary based on tonnage band

Joint submissions with cost sharing will be possible as well as use of an “OnlyRepresentative” to coordinate information exchange between the registrant(s) andthe authority

Assessment may result in a change of the existing hazard type

Proposed Existing Substance Management

SUMMARY

Depending on classification, a notification, registration and/or licenseis necessary

Products containing substances with hazardous properties must benotified for listing in list 5.6

Setup of a chemical inventory is ongoing

Risk Assessments might be required for some new and existingchemicals (SVHC type chemicals)

GHS Implementation Worldwide

With support from J. Breuer,

jbreuer@knoell.com

GHS – Globally Harmonized System

Goal (United Nations)

a single, globally harmonized system to address

classification of chemicals, labels, and safety data sheets

expand the harmonization of the transport sector (UN

Model Regulations for Transport of Dangerous Goods) to

the workplace and consumer sectors

enhance the protection of human health and the

environment during the handling, transport and use of

chemicals

facilitate trade by harmonized rules and regulations at

worldwide level.

Introduction

„Purple Book“

GHS – Globally Harmonized System

HistoryFirst edition of the GHS adopted in December 2002 and published 2003

Update and revision every two years

GHS Rev.1 (2005)

GHS Rev.2 (2007)

GHS Rev.3 (2009)

two new sub-categories for respiratory and skin sensitization

GHS Rev.4 (2011)

new hazard categories for chemically unstable gases and non-flammable

aerosols

GHS Rev.5 (2013)

GHS Rev.6 (2015)

new hazard class for desensitized explosives; new hazard category for

pyrophoric gases

Hazards are grouped into physical,

health and environmental hazards which again

are divided into hazard classes and categories.

Countries are free to determine which

of the building blocks will be applied.

However, where a system covers part of

the GHS, that coverage should be

consistent with UN-GHS!

This means that any hazard category which is

implemented in a national regulatory system, is implemented with all the

corresponding GHS criteria.

Building Block approach:

Global Implementation ─ Various Shades of Purple

Origin

w.freew

GHS implemented GHS not yet startedGHS voluntaryGHS in process

Status quo: April 2017

✓ What kind of regulation is existing in my target markets?

(new chemicals, existing chemicals, hazardous chemicals?

✓ What are the relevant inventories and local data requirements?

✓ Which options are available to fill these data-gaps?

✓ What does this mean with regards to envisaged timelines?

✓ Rules for Classification and labelling (GHS)?

✓ Special issues (SVHCs)?

✓ Language issues?

✓ Do you need external help?

Summary

When setting up your global business plan /your plan for global

compliance, check:

Thank you for

your attention!

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