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© 2017 Underwriters Laboratories Inc.

REACH’s consequencesAn overview of how REACH is spreading globally

Presented by:

Christine Lepisto

Regulatory Expert

2017Chemical Watch Expo 2017 | UL-SCS/WERCS

Chemical Watch | Expo 2017

Agenda

1. Roots of REACH

2. REACH in the rest of Europe

3. REACH Reaction: example China

4. REACH Evolution: example South Korea

5. REACH Additional obligations: example USA

6. QA

2

Roots of REACHA look at the new model of chemical control that will spread


Country Year Legislation

European Union 1967European Inventory of Existing Commercial chemical Substances/ European List

of Notified Chemical Substances/ No-longer Polymers (EINECS/ELINCS/NLP)

Japan 1973 Existing and New Chemical Substances (ENCS)

USA 1976 Toxic Substances Control Act Section 8(b) Inventory (TSCA)

Australia 1989 Australian Inventory of Chemical Substances (AICS)

Philippines 1990 Philippine Inventory of Chemicals and Chemical Substances (PICCS)

Canada 1990 Domestic and Non-Domestic Substances Lists (DSL/NDSL)

Korea 1991 Korean Existing and Evaluated Chemical Substances List (KECL)

New Zealand 2006 New Zealand Inventory of Chemicals (NZIoC)

Turkey 2008 Regulation on Inventory and Control of Chemicals

Mexico 2009 National Inventory of Chemical Substances (INSQ)

Malaysia 2009 Environmentally Hazardous Substance Notification and Registration (EHSNR)

China 2009 Inventory of Existing Chemical Substances in China (IECSC)

Taiwan 2014 Taiwan Chemical Substance Inventory (TCSI)

Before REACH: Chemical Control Laws


Chemical Control Laws: a flawed model

➢ “Existing Chemicals”

▪ All chemicals in commerce

nominated Assumed safe

▪ Burden of proof on the authorities

➢ “New Chemicals”

▪ Registration costs a disincentive

to R&D

5

Fun fact: Over 100,000

substances listed in the EU

when REACH was adopted!


REACH Registration proceeds in Europe

6https://echa.europa.eu/documents/10162/13628/evaluation_under_reach_progress_report_2010_en.pdf

http://www.echa.europa.eu/documents/10162/13629/reach_2013_result_stats_en.pdf

https://www.linkedin.com/pulse/latest-statistics-reach-registrations-2018-deadline-echa-fazendeiro

Sources:

1 June

2008

1 Dec

2010

1 Dec

2008

31 May

2013

31 May

2018

>1000 t/y

CMR; N

>100 t/y

>1 t/y

Non-phase-in Substances (not in EINECS/ELINCS)

+2998 = 6673

3675 substances

+5773 = 12.5K | 12.5K?

Mid-2016

Total Dossiers

2010: 21 662

2013: 9 000

2018: 60 000?

Pre

-

regis

tratio

n

https://echa.europa.eu/documents/10162/13628/evaluation_under_reach_progress_report_2010_en.pdf

http://www.echa.europa.eu/documents/10162/13629/reach_2013_result_stats_en.pdf

https://www.linkedin.com/pulse/latest-statistics-reach-registrations-2018-deadline-echa-fazendeiro


REACH Registration costs

7

Tier ECHA Fee Registration costs

>1000 T/y €25,274

100 –

1000 T/y

€9376

10-100 T/y €3506

1-10 T/y €1304

• Fees and data make half the costs

• In-house staff costs <25% for >75% of

firms surveyed

• Consulting costs <25% for >75% of firms

surveyed

Source: CSES-REACH-COST-andOtherCaseStudies_market-annex_en

Interim Evaluation: Functioning of the European chemical market after the introduction of REACH, Final report, 30 Mar 2012

Sources:

%

Thousand €

Average cost 50-100K€

Lead registrant

Simple registrant


What makes REACH “REACH”?

➢ No ‘existing’ chemicals

▪ No ‘safe’ assumptions, all treated like new chemicals

➢ Data sharing

▪ Required to minimize animal suffering

➢ No Free Rides

▪ It’s not an inventory, it’s a buy-in to the ownership of data proving chemical safety

▪ Prove safe use – burden on industry

➢ Exposure scenarios – workers, public, and environment

8

New substance:

a liquid with ‘holes’ in it

First wave of expansion: REACH in EuropeOutside the European Union


Non-EU Members: REACH reciprocity or parallel system

10

➢European Free Trade Association (EFTA) Countries

▪ European countries not in the European Union reduce trade barriers

and ensure equivalent protections

▪ Norway, Iceland, Lichtenstein, and Switzerland

➢Norway, Iceland, Lichtenstein are part of REACH through the

European Economic Area (EEA) multi-lateral agreements

➢Switzerland enforces the provisions of REACH via national

regulation (ChemV)

➢Britain post-BREXIT ???


Turkey REACH and real Turkey REACH

11

➢Turkey REACH

▪ Regulation on the Inventory and Control of Chemicals (CICR)

▪ Two tonnage bands 1-1000 and >1000 T/y

▪ Notification of data in possession of notifier

➢Real Turkey REACH

▪ KKDIK Regulation: KKDIK is the acronym for REACH in Turkish

▪ As an EU accession candidate, Turkey implements national regulations

equivalent to EU regulations

REACH ReactionChina MEP Order 7


China – MEP Order 7 Inventory of Existing Chemical Substances (IECSC)

13

“This regulation is similar to EU REACH

and is also known as ‘China REACH’”Source: the internet, so it must be true (???)

Fun fact:

This tiger is not grimacing about

REACH or MEP 7. ‘Stinking face’ is an

instinctive response that opens the

vomeronasal, or Jacobson's Organ, for

better identification of chemical odors

Image (and fun fact) Credit:

Rob Bixby, CC-by-2.0

https://www.flickr.com/photos/scubabix/15195503094/

https://creativecommons.org/licenses/by/2.0/Sources:

https://www.flickr.com/photos/scubabix/15195503094/

https://creativecommons.org/licenses/by/2.0/


China REACH – MEP Order 7 Measures for the Environmental Management of New Chemical Substances

14

Regular new

substance

Isolated

Intermediate

Product and

Process R&D

Polymer of

Low Concern

Scientific Research

or

Testing

Simplified notification –

general conditions

100 kg/y 1 t/y 10 t/y

Simplified notification –

special conditions

Simplified notification – special conditions (valid 2 yr)

Simplified notification – special conditions (No volume limit)

Simplified

notification

Simplified

research

record

Regular notification


Regular

notification



China REACH – Confidentiality measures

15

Chinese agent

Importer 2Flow of goods

Flow of information

Non-Chinese

supplier

EU Manufacturer

Importer 1

Certificate issued


China MEP Order 7 vs. EU REACH

16

➢Existing Chemicals

▪ EU REACH: applies to ALL chemicals >1 T/y/entity

▪ China REACH: Applies only to NEW chemicals

▪Not required for >45,000 substances listed on IECSC

▪New substances >=1 T/y full registration

▪No de minimus threshold for some notifications and R&D

notification is limited to 0.1 T/y (100 Kg)



17

➢Data sharing

▪ EU REACH: Tiered dossier by tonnage band; data sharing mandatory.

Industry SIEF mechanism to determine how to share costs

▪ China REACH: Tiered dossier by tonnage band; no requirement for

data sharing

▪Subsequent notifier can use the dossier submitted by notifier-1

with notifier-1’s permission – but must comply with the testing for

the sum of notifier-1 + notifier-2’s manufacturing/import tonnage

▪Joint notifiers also must submit data relative for the combined

tonnage


China MEP Order 7

18

➢Data sharing example

▪ Notifiers A and B have no connection in this example but the data level

for notification must comply to the sum of all notifiers’ tonnage

Data for regular

notification level 1

Notifier A

Notifier B

Substance X

Purchase

access rights

Regular

notification 8 t/y

Regular

notification 5 t/y

OK

NO

Only 2 t/y can be permitted

based on data available



19

➢No free rides?

▪ EU REACH: Joint or individual registration allowed, but all companies

marketing the substance over the threshold quantity must register

▪ China REACH: IECSC is not static! After a substance is added to the

China Inventory, there seems to be no requirement of China REACH to

further register the substance

Company ARegular

notification 10 t/y

After 5 years,

substance listed

on IECSC

OK

Company B

Free rider,

unlimited tonnage



20

➢Proof of safe use

▪ EU REACH: Chemical safety assessment if >10 T/y

▪ China REACH: Risk assessment starting at > 1 T/y; RA must follow

Chinese guideline – cannot reuse EU CSR

➢Communication in supply chain to ensure safe use

▪ EU REACH: Extended SDS and other support to downstream user,

who is responsible to ensure their own safe use

▪ China REACH: obligation not to sell to downstream users that are not

capable of implementing the Risk Management Measures (RMMs) for

safe use


China MEP Order 7 – other differences

21

➢ Polymers

▪ EU REACH: Notify monomers

▪ China REACH: Notify all new polymers (simplified if new monomers <2% and

“polymer of low concern”)

➢ Submittal rights

▪ EU REACH: only an EU-based “natural or legal person” can register; no specific OR

requirements

▪ China REACH: Foreign entity can submit directly to MEP or through their subsidiary

or through an Only Representative (OR); Local agent can submit through an OR; OR

must meet minimum requirements (capital, fixed work place, experience, no

violations in last 3 years)

➢ Lab requirements

▪ EU GLP versus China: Ecotox tests in Chinese laboratories


Other Reactions

22

➢ Reaction drivers

▪ Responsible chemical management policies advocated by United Nations

▪ Trade protection motivator

➢ Reaction characteristics

▪ More emphasis on generating data for existing chemicals

▪ Duties to provide information to governments and users

➢ Reaction spreading

▪ Malaysia

▪ Taiwan

▪ Thailand

REACH EvolutionKorea REACH (a.k.a. K-REACH) and !!!New!!! MoE 2016-869


Korea REACH – a.k.a K-REACHAct on Registration and Evaluation of Chemical Substances, etc.

24Image source: Ministry announcement (http://eng.me.go.kr/eng/web/index.do?menuId=167&findDepth=1)


K-REACH vs. EU REACH

25

➢Existing Chemicals

▪ EU REACH: applies to ALL chemicals >1 T/y/entity

▪ K-REACH: dual reporting/registration scheme covers all new and

existing chemicals

▪Reporting: the first level of obligation is to report the use of the

new chemical or at least 1 T/y of the existing chemical

▪Registration: applies for new chemicals but only applies to

existing chemicals designated as subject to registration – existing

chemicals may be designated at quantities < 1 T/y



26

▪ CICO: Chemical Information Communication

Organization = SIEF

▪ under KCMA (Korea Chemicals Management

Association) but transitioning to KECO (Korea

Environment Corporation)

▪ Data acquisition support by KECO and NIER (Natl.

Institute of Environmental Research)

➢Data sharing

▪ EU REACH: Tiered dossier by tonnage band; data sharing mandatory.

Industry SIEF mechanism to determine how to share costs

▪ K-REACH: Tiered dossier by tonnage band



27

➢No free rides?

▪ EU REACH: Joint or individual registration allowed, but all companies

marketing the substance over the threshold quantity must register

▪ K-REACH: For a substance on the Korean Existing Chemicals List, the

Ministry of Environment may designate that registration is required.

Other existing chemicals are subject to annual reporting, but not

registration



28

➢Proof of safe use

▪ EU REACH: Chemical safety assessment if >10 T/y

▪ K-REACH: Submittal of ‘risk data’ in addition to hazard data starts at >

100 T/y (stepping down to 10T/y in 2020); Ministry must make a risk

assessment

➢Communication in supply chain to ensure safe use

▪ EU REACH: Extended SDS and other support to downstream user,

who is responsible to ensure their own safe use

▪ K-REACH: Two-way communication requirement in supply chain is

modelled on REACH



29

➢ Polymers

▪ EU REACH: Notify monomers

▪ K-REACH: Notify all new polymers

➢ Exemptions

▪ EU REACH: User determines that their case is exempt

▪ K-REACH: ‘confirmation of registration exemption’ required for cases like R&D, non-

isolated intermediates, export-only goods

➢ Reporting

▪ EU: none required under REACH

▪ K-REACH: requires annual report of uses, quantity and other matters defined by

ordinance


Korea Ministry of Environment Announcement 2016-869

30

➢Key proposed amendments to K-REACH

▪ Objective: reduce the focus on prioritized lists (toxic / authorized /

restricted / prohibited) and exert hazard-based controls prioritizing

hazards such as CMR, PBT, and endocrine disruptors

▪ Article 8: abolish reporting, introduce chemical pre-registration

▪ Article 9: 3-phase registration system of existing substances abolished

▪ Article 10: registration for ~7000 existing substances (≥1t/y) will apply

▪ Article 25: improve management system of approved substances

▪ Article 29: Expand information communication requirements

▪ Article 32: notification of chemicals contained in products



Milestone Anticipated timeline

Comments Feedback Closed Feb 2017

Guidance Project started with DRAFT anticipated late 2017

and final guidance in 2018

Final K-REACH Amendment June 2017

Pre-registration Beginning late 2017

Enforcement date of K-REACH amendment June 2018 (1 year after amendment enacted)

Expected tonnage band schedule*:

>= 1000 t/y: July 2018 – June 2021

100 – 1000 t/y: July 2021 – June 2024

10 – 100 t/y: July 2024 – June 2027

1-10 t/y: July 2027 – June 2030

31

*NOTE: Due date for Phase 1 PECs remains unchanged: June 2018!



Obligation Current K-REACH Amended K-REACH (anticipated)

Reporting New and existing substances >= 1t/y Abolished (NOTE: CCA reporting)

Pre-registration Not applicable Existing substances >= 1t/y

Registration All new chemical substances

PECs >= 1 t/y

All new chemical substances >= 0.1 t/y

Existing substances >= 1t/y (by tonnage

band deadlines)

510 PECs deadline June 2018

Substance

notification

New chemical substances <0.1 t/y

Product

notification

Contain hazardous substances >= 1 t/y Contain hazardous substances >= 1 t/y

Exemptions KCMA evaluation KECO takes over from KCMA

Risk

management

Communicate hazardous substance

Manage risk-concern product

Risk assessment by tonnage bands

Communicate risk-concern substance

Manage risk-concern product*

Risk assessment same timeline

32*NOTE: Safety Control Act of Household Chemical Products and Biocidal Products


K-REACH: where are we at now?

33

➢ 510 Priority existing chemicals (PEC)

▪ First successful joint registration (HBr, CAS 10035-10-6) has recently

been issued a registration number by MOE/NIER

▪ Original deadline for K-REACH registration of 30 Jun 2018 will still

apply. Companies concerned by this notice should focus first on any of

these 510 PEC substances, ensuring that they have a process in place

to work with the industry joint registration group to ensure their

continued marketing of the products containing such substances

remains legal in Korea

➢Annual reporting

▪ Continues at least for 2017 reporting (30 June deadline)

Additional obligations from REACHDon’t overlook the consequences of new information


REACH – Global Data Flows

35Free Software Commercial Software

IUCLID

Bulk XML

REACH-ITIn-house

Database

Company

files

C&L Notification

Registration

China NCSN

K-REACH

USA TSCA


Additional information example: USA TSCA

➢TSCA Section 8(e)

(e) Notice to Administrator of substantial risks

Any person who manufactures, processes, or distributes in commerce a chemical substance

or mixture and who obtains information which reasonably supports the conclusion that such

substance or mixture presents a substantial risk of injury to health or the environment shall

immediately inform the Administrator of such information unless such person has actual

knowledge that the Administrator has been adequately informed of such information.

▪ “Immediately” = within 30 days

36Source: http://uscode.house.gov/view.xhtml?path=/prelim@title15/chapter53&edition=prelim



➢CEFIC memorandum on TSCA Section 8(e)

▪ This requirement applies to entities in the U.S. (including importers), not

to exporters from the EU to the U.S. However, in some cases where EU

entities have knowledge of such information, their U.S. affiliates may

have that knowledge also. In addition, in some cases EPA may infer that

the U.S. affiliate has that knowledge, particularly where the U.S. entity is

the parent of the EU affiliate. In those cases, EPA may consider that the

U.S. affiliate is required to submit such information to EPA.

37

Source:

http://www.cefic.org/Documents/IndustrySupport/Cefic%20legal%20note_REACH%20confidentiality%20

obligations%20and%20TSCA%20%C2%A7%208%20(e)_20.09.10.pdf



➢TSCA Section 8(e) FAQ

▪ Any information, including preliminary information, from human health

and safety studies and animal studies on a chemical in commerce that

implicates the tested chemical causes toxic effects when there is also an

exposure concern should be reported to EPA under TSCA §8(e). The

decision to report should not hinge in any way on a judgment about the

relevance of the findings to an assessment of human risk. For the most

serious toxic effects (e.g., cancer, neurotoxicity, birth defects), the

decision to report should not even depend on a judgment of actual or

potential exposure to the chemical. The mere fact that the chemical is in

commerce constitutes sufficient evidence of exposure.

38Source: Toxic Substances Control Act Section 8(e): Frequent Questions

https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/toxic-substances-control-act-section-8e-frequent



➢TSCA 8(e) Penalties for PFOA (perfluorooctanoic acid)

▪ $10.25 million penalty to DuPont

▪ $1.52 million reduced penalty to 3M for 244 violations under an EPA

compliance incentives policy allowing self-disclosure and voluntary audit

▪ How does a $25,000* maximum penalty get so huge?

▪ Multiplier: per day

▪ Multiplier: per violation

*Note: penalties increase for inflation, current penalty max = $38,114

39Source: Publication EPA-325-F-08-002,

Enforcement Alert: Failure to Report Chemical Risks Can Result in Major Fines


REACH – Safe use information to global users

40Free Software Commercial Software

CHESAR

+Plug-ins

ECETOC TRA

PETRORISK

EUSES (Env)

ConsExpo

Supply chain

FEEDBACK LOOP

IUCLID

Bulk XML

REACH-ITIn-house

Database

Company

files

C&L Notification

Registration


Summary: from the roots of REACH,

chemical control obligations grow globally

Reaction,

Evolution, and

Additional Information on

CHemicals

41


Thank You

42