chemical watch expo · chemical watch expo berlin, germany, april 25 th–26 , 2017 dr. michael...
TRANSCRIPT
Chemical Watch EXPOBerlin, Germany, April 25th – 26th, 2017
Dr. Michael Cleuvers, Managing Director Industrial Chemicals & Biocides
1
Integrating REACH compliance with global compliance
– Developments in East-Asia
2
EU
ChinaKorea
Taiwan
Thailand
Malaysia
Philippines
Vietnam
Indonesia
Agenda
3
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»
4
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
5
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)
6
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
8
The global perspective
10
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
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
China
G. N.
Korea
F. N.
Japan
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
Data
Waiver Read-
across,
QSAR
New
study
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,
27
Chemical management in China
- Nie, 2012 (modified)
Existing chemicals (IECSC, 2013)
Not regulated
28
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, ..)
Yes
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)
New chemical substances,
manufactured / imported < 1 t/a
Simplified Notification(specific conditions)
New chemical substances,
- 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
New chemical substances,
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
t/a
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)
35
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
36
REPORTING(Chemicals & Mixtures)
AuthorizationToxic substances
RISK
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
38
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.
39
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
40
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
41
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
42
Product notification
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.
When
▪ 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
KECI
43
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
PECs
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
44
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
Product notification
▪ Biocidal products are to be regulated under a separate regulation (similar to EU BPR)
46
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
TCSCA
New Chemical Substance (NCS) — Notification Basics
47
• 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
0
No Requirements Small Quantity Registration
Small Quantity RegistrationStandard Registration
(Level I)0.1 Simplified Registration
1
Small
Quantity
Registration
Simplified RegistrationStandard Registration
(Level I)
Standard Registration
(Level II) ++4
10
Standard Registration
(Level I)
Standard Registration
(Level II) ++
Standard Registration
(Level III) ++
100Standard Registration
(Level III) ++Standard Registration
(Level IV) ++1000
Standard Registration
(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.
48
Registration of existing substances
49
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.
51
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)
52
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”
686
12
2 DOF 2.1 Discrete Substances
2.2 Groups
2.3 Classes by “properties” or uses
17
2
2
3 DLD 3.1 Discrete Substances
3.2 Groups and classes by “properties” or uses
23
13
4 FDA 4.1 Discrete Substances
4.2 Groups
4.3 Classes by “properties” or uses
224
28
6
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*
488
62
2
10
15
-
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
54
New list 5.6
55
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.
56
Current Management
of
Existing Chemicals
57
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)
58
59
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…”
60
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
62
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
tml
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
63
Search by CAS RN or Trade Name
Online Draft Inventory
Formaldehyde
64
65
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
66
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
67
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)
68
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
70
„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
71
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.
72
Building Block approach:
73
Global Implementation ─ Various Shades of Purple
Origin
al wo
rld m
ap b
y ww
w.freew
orld
map
s.net
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:
76
Thank you for
your attention!
For more detailed information /
questions please visit us
at our booth