REACH in April 2007

17 April 2007, Seoul, Korea

DaeYoung PARK

Korea Environmental Council in Europe

• About KECE

• Basics of REACH and Chemical Regulations

• REACH – Moves of EU Institutions

• REACH – Moves of EU Member States

• REACH – Moves of EU Companies

• Conclusion

REACH in April 2007

Rules of Play• “No rules are developed in REACH Regulation to elect the “Lead Registran

t”. [If this is so, shouldn’t the Guidance Document provide for more details? What happens, if more than one registrant want to take the lead? What happens if no registrant wants to be lead registrant? What happens if the other registrants don’t agree on the lead? Does he necessarily have to act on behalf of ALL other registrants?

• A pre-SIEF or SIEF is only a virtual group of registrants with the same objectives (sharing data for the same substance and find mutual agreement on C/L). In practice it will be hardly impossible to bring all these registrants together in a meeting somewhere in Europe and find mutual agreement on general topics. This will cost too much time to arrange. On the other hand for a registrant it will be practically impossible to attend all meetings of a SIEF or consortium for his substances. Hence, we could end up in a time consuming discussion over email or telephone without any result.

• The period for pre-registration is from 1 June until 1 December 2008. Pre-registration is not obligatory. Companies are free to opt for immediate registration after 1 June 2008. In this case, they will have to suspend their activities and can only resume them after registration is complete.

Discussion in SEG Meetings in Feb-Mar 2007

Korea Environmental Council in Europe ( 구주산업환경협의회 )

Korea EU

• 27 Member States

• EU Institutions

• EU Industries

MOCIE MOE Industries

Unit B

Unit A Unit A

Unit B

FKI

KOCHAM

KEA

KAMA

…KECE

• Only Korean Organization accredited by the European Parliament

• Civil Society Member registered with DG Trade, Communication Channel with DG Environment, DG Enterprise (TBT), DG External Relation

• Organizational Stakeholder of GRI

• Delegation for REACH SEG-SEA

Basics of REACH & Chemical Regulations in EU

Risk = Exposure x HazardKorea

EU

Before REACH After REACH

Classification of Chemicals (화학물질분류 )

TCCA ( 유해화학물질관리법 )- 신규화학물질 , 기존화학물질 명시적 분류 및 정의 (2004 년 12 월 31 일 개정 , 2006 년 1 월 1 일 시행 )- 유해성 , 위해성 명시적 정의

Directive 67/548/EEC on the classification and labeling of chemicals

Regulation on the implementation of the Globally Harmonized System of Classification and Labeling of Chemicals (Proposal)

New Chemicals

( 신규화학물질 )

TCCA ( 유해화학물질관리법 )

- 유해성평가 (1990 년 8 월 1 일 제정 , 1991 년 2 월 1 일 시행 )

ISHA ( 산업안전보건법 )- 유해성조사 (1990 년 1 월 13 일 개정 , 7 월 13 일 시행 )- 유해위험성조사 (2002 년 12 월 30일 개정 , 2003 년 7 월 1 일 시행 )

Council Directive 92/32/EEC of 30 April 1992 (6th Amendment to Directive 67/548/EEC)- Risk Assessment of New Chemicals- Sole Representative for Non-Community Companies

No Differentiated Treatment of New and

Existing Chemicals

Existing Chemicals

( 기존화학물질 )

TCCA ( 유해화학물질관리법 )- 위해성평가 도입 (2004 년 12 월 31 일 개정 )- 위해성평가의 대상물질 선정기준 , 절차 및 방법 등에 관한 지침 (국립환경과학원 고시 제 2006-30 호 , 2007 년 1 월 10 일 )

Council Directive 79/831/EEC of 18 September 1979 (6th Amendment to Directive 67/548/EEC)- European Inventory of Existing Chemical Substances (EINECS) (1 January 1971 – 18 September 1981)- European List of Notified Chemical Substances (since 19 September 1981)

REACH & Member States Chemical Regulations in EU• European Union

REACH & Member States Chemical Regulations in EU

• Germany

REACH & Member States Chemical Regulations in EU

• REACH is only handful parts of chemical regulations in Member States, not ALL.

Austria

EU Chemical Regulations after 1 June 2007 - Transition

Directive 91/155/EEC (Information to be included in safety data sheets) Repeal 1 June 2007

Article 14 (provision of safety data sheets) of Directive 1999/45/EEC

(Classification, packaging, and labelling of dangerous preparations)

Deletion 1 June 2007

Directive 93/105/EC (Information required for Technical Dossiers)

Directive 2000/21/EC (amending the Dangerous Substances Directive)

Regulation (EEC) No 793/93 (Evaluation and control of the risks of existing substances)

Regulation (EC) No 1488/94 (principles for risk assessment of existing

substances)

Repeal 1 June 2008

Directive 93/67/EEC (Risk assessment for new notified substances)

Directive 76/769/EEC (Restrictions on the marketing and use of certain dangerous substances and preparations)

Repeal 1 June 2009

By 1 June 2012, the European Commission will review of scope of REACH to avoid overlaps with other legislation.

Chemical-Related Regulatory Developments of Member States in 2006

0

10

20

30

40

50

60

70

80

90

100

1

Belgium

Czech Republic

Denmark

EU

Finland

France

Germany

Hungary

Ireland

Italy

Nertherlands

Norw ay

Poland

Portugal

Rominia

Slovakia

Spain

Sw eden

Turkey

United Kingdom

Luxemburg

Member States

Among 233 Issues, 16 issues are REACH-related.

Moves of EU Institutions: Historical Enforcement on Chemicals

Year Scope Project Name

1995 - 1996

Notification of New Substances Dir. 67/548/EEC resp. 92/32/EEC

NONS

1997 - 1999

Existing Substances Regulation Reg. (EEC) 793/93

EUREX

1999 - 2000

Cadmium restriction Dir.76/769/EEC, 91/338/EEC resp. 1999/51/EC

EuroCad

2002 - 2004

C&L and SDS of Preparations ; 1999/45/EC 2001/58/EC 

ECLIPS

Source: CLEEN (Chemicals Legislation European Enforcement Network)

“Nearly 4 000 substances were checked at 96 companies. Almost 8% could not be identified or were found to be new and about 40% of the new substances not notified and thus illegally marketed. Of the 66 samples taken within the framework of NONS project, 29 are analyzed. 31% of the analyzed products do not conform with the information provided by the company”

“About 9 % of the companies were in violation because they had not given the legally required information about their substances and 24 % of the companies were too late in giving the information. Important reasons for violations were problems due to the reorganisation or merger of companies and difficulties in correctly understanding the Regulation”

“As many of the inspected products were imported from outside the EU during this project the custom authorities had to be involved. During the inspections it turned out that there were no harmonised methods for analysing Cd in plastic products leading to the recommendation to describe an analytical method for the determination of CD in plastics. The results showed that almost all products having a Cd content that exceeded the limit value were found to be imported from the far east of Asia”

“Considerable deficiencies have been found in the indication of danger on dangerous chemicals. The labelling of 60% of the preparations currently on the market, as well as about two thirds of the safety data sheets do not comply with the regulations”

Moves of EU Institutions: SEGs & TGDs On-Going Prototype REACH Overall Guidance Package – “REACH Navigator” (http://194.185.30.169/reach_site/index_en.htm)

15 February 2007: European Commission and the 27 Member States launched a REACH Help-Net (http://ec.europa.eu/enterprise/reach/helpdesks_en.htm)

Comitology:

• Implementing Measures (e.g. Testing Methods),

• Amendments,

• Other Decisions

Project Legislation Project scope Time Status

REACH Enforcement

Project

Reg. (EC) 2006/1907

REACH enforceability

2006- Running

CLEEN (Chemicals Legislation European Enforcement Network)

Moves of EU Member States: Title XIV - Enforcement

• maintain a system of official controls and other activities as appropriate to the circumstances (Art.125)

• lay down the provisions on penalties applicable for infringement of the provisions of this Regulation by 1 December 2008 and shall take all measures necessary to ensure that they are implemented (Art.126)

• report the results of the official inspections, the monitoring carried out, the penalties provided for and the other measures (Art.127)

Member States shall:

Enforcement of REACH in the

UK (Proposal Status)

United Kingdom

• Health & Safety Executive (GB)

• Health & Safety Executive (HSENI)

• Health & Safety Executive (GB)

• Health & Safety Executive (NI)

• Environment Agency (England & Wales)

• Scottish Environment Protection Agency (SEPA)

• Northern Ireland Environment & Heritage Service (EHSNI)

• Local Authorities

Registration & information in the supply chain

Use of chemicals

(Local Authorities – health & safety regulations, consumer protection)

Source: Defra (2007)

• HM Revenue & Custom Import/export controls

Enforcement Activities by UK Authorities (Proposal Status)

• Manufacture, import, sale, supply or use of substances without the appropriate registration

• Use of a hazardous substance outside the terms of an authorization or contrary to a restriction

• Failure to provide required information up and down the supply chain

• Failure to comply with other duties regarding recommendations, e.g. worker’s or consumer’s rights of access to information

• Failure to comply with the duties to cooperate and to supply information (in a timely manner)

Existing Statutory Instruments under Review for Amendment or Revoke

Source: Defra (2007)

Moves of EU Companies: At least 10-Years Experience …

• Since October 1998, through Global Initiative on High Production Volume (HPV) Chemicals, they have learned:– Globally harmonised, internationally agreed data sets

and initial hazard assessments – Elimination of duplication of testing and assessment

efforts – Minimization of the cost for the industry – Reduction on the number of animals for testing – Establishment of International Consortia– Cost Sharing

Moves of EU Companies: 10-Years Experience …

• 2007 년 4 월 2 일 환경부 보도자료

Moves of EU Companies: Consortia• BASF: e-Caprolactam-consortia, Sodium dithionite-consortia, Ammonium sulphate-consortia, T

HEIC consortia, Hexamethylene Diisocyanate consortia, Dotted Rutil-consortia, Methylheptenone-consortia, N,N-DMF-consortia, Mucochloric acid-consortia, 1,3-DMU-consortia, AH Salt-consortia, Ammonium chloride-consortia, Butylene oxid-consortia, Diarylide Yellow Pigments, Formic acid-consortia, Isophorone diamine consortia, Methoxy-2H-Pyran-consortia, C.I. Pigment Green 7 consortia, Prenol consortia, Trimethylammonium chloride consortia, Vinyl Ether-consortia, IBDU-consortia, Formaldehyde-consortia, NaOH consortia, Chlorine ICCA-consortia, Potassium hydroxide, Prenal consortia, DEAE consortia, Methanol consortia, Beta-Jonon consortia, Formamide consortia, TPP consortia, 2-Mercaptoethanol consortia, Thiodiglycol consortia, Xanthine consortia, Lysmeral consortia, Linalool consortia, Ethylene Glycol Ethers Low Boilers consortia, 4-Nitrotoluene consortia, o-Toluidine consortia, Methanolate consortia, ACC Formic Acid & Formates Panel, ECPI Higher Molecular Weight Phthalates consortia, ECPI Oxo Alcohol consortia, EFMA/TFI Fertiliser Chemicals consortia, Isophytol consortia, Pseudoionone consortia, Ethylene Glycol Ethers EPh consortia, Propylene Glycol Ethers PPh consortia, Propylene Glycol Ethers consortia, CSA consortia (Chloro sulfuric acid), Adipic acid consortia.

• Nippon Steel Chemical Co. Ltd.: Ammonium sulphate-Consortia, Xylene Consortia, Phthalic anhydride consortia, ACC Cresols Consortia, Divinylbenzene Consortia.

• Nippon Petrochemicals Co. Ltd.: International Hydrocarbon Solvents Consortia, Xylene Consortia• Shell Chemical Company: Ethylene Glycol Ethers Low Boilers Consortia, Ethylene Glycol C

onsortia, Ethylene Oxide Consortia, ACC Oxo Process - Isobutyl Series Consortia, Aliphatic Alcohols Consortia, Xylene Consortia, 1,2,3-Trichloropropane consortia, Ethylene Glycol Ethers High Boilers Consortia

• Akzo Nobel: Hydrogen consortia, sodium (hydrogen) sulphide consortia• General Electric Silicones: Methyl Chloride Consortia

NB: Historical Data of Chemical Consortia - ICCA

Moves of EU Companies: Hundreds of Consortia being formed or to be formed• Salicylic Acid Consortia: Mitsui Chemicals Inc., Yoshitomi Fine Chemicals, Rhodia(France), Bayer AG• Sodium (Hydrogen) Sulphide Consortia: Akzo Nobel, Atofina Chemicals, Inc., Solvay Barium Strontium GmbH, Tessenderlo Chemie n.v. • Soluble Silicates Consortia: Cognis Deutschland GmbH, Silmaco n.v, Woellner Silikat GmbH, SASOL Italy S.p.A., Rhodia (France), Solvay S.A., FMC FORET SA, INEOS Silicas Ltd, Industrias Quimicas del Ebro SA, van Baerle Chem Fabrik GmbH & Co., Van Baerle & Cie AG, Asahi Glass Co., Ltd., Tokuyama Corporation, Industria Chimica Vera• Sulphuric Acid Consortia: Mitsui Mining & Smelting Co., Ltd., Ishihara Sangyo Kaisha, Ltd., Ube Industries, Ltd., Onahama Smeltng & Refining Co.,Ltd., Kowa Seiko Co., Ltd., Sumitomo Chemical Co., Ltd., Sumitomo Metal Mining Co., Ltd., TAYCA Corporation, Toagosei Co., Ltd., Toho Zinc Co., Ltd., Tomakomai Chemical Co., Ltd., Dowa Mining Co., Ltd., Nankai Chemical Industry Co., Ltd., Nissan Chemical Industries, Ltd., Nisso Metalo Chemical Co., Ltd., Nippon Mining & Metals Co., Ltd., Nippon Phosphoric Acid Co., Ltd., Hachinohe Smelting Co., Ltd., HibiI Kyoudo Smelting Co., Ltd., Mitsubishi Materials Corporation, Tomoe Chemical Industry Co., Ltd., Showa Denko K. K., Sumitomo Seika Chemicals Co.,Ltd., Akita Zinco Co., Ltd., Inco TNC Ltd., Furukawa Co., Ltd., Mitsubishi Chemical Corporation

Source: ICCA

Moves of EU Companies: Cost Sharing in EU Consortia

An example for a hypothetical product A: After review by the appropriate authorities it is decided that further testing costing 200,000 units is required. The total cost of toxicity testing for both companies is therefore 50,000 + 100,000 + 200,000 = 350,000.

Company X Total cost = 60% of 350,000 = 210,000Company Y Total cost = 40% of 350,000 = 140,000

Company X further test cost = 210,000 - 50,000 already spent = 160,000Company Y further test cost = 140,000 - 100,000 already spent = 40,000

This appears to be a fair and equitable way of apportioning the cost. The "Realistic Standard" (RS) is a cost of test to ensure that companies are not penalized financially by using the above method for carrying out valid tests some time ago while the cost has since escalated under inflationary pressures.

Company Market share Toxicity testing cost to date(nominal units)

XY

60%40%

50,000100,000

Source: ICCA

Moves of EU Companies: Cost Sharing in EU Consortia

• A company's share should reflect its economic interest in the sum of all of the chemicals included in the category.

• Total costs for the category will be lower than the costs of assessing all of the members of the category individually

• The costs to be borne by each company in a consortium should be lower than if the chemicals in the category were being assessed individually

Company Market ShareProduct A

Market ShareProduct B

Market ShareProduct C

Share of Test Costs

X 25 50 40 38,333

Y 25 20 40 28,333

Z 50 30 20 33,333

Total   100,000 units

A group of hypothetical products, A, B and C, being assessed as a category (production volumes of A, B and C are equal):

Source: ICCA

Basic Rules of EU ConsortiaCase of A Industry Association

• Members A Industry Association to manage the implementation of REACH (i.e. X Consortia) on behalf of the industry

• A Industry Association provides technical resources to X Consortia• The scope of X Consortia determined:

– Pre-Registration– Data Gap Analysis– CSR/CSA– Registration– Dossier preparation (possibly including the submission of dossier)

• A Industry REACH Task Force prepares a strategic plan and X Consortia Agreement

• A strategic plan for REACH (including X Consortia) to be announced at X Industry Annual Conference in Japan in May 2007

• X Consortia to be formed in the final quarter of 2007• Other works, e.g. contact with DU, interaction with other trade associations, broad

participants in the supply chain

Freeriding under Scrutiny by EU Companies: Only Representative

Source: European Association of Metals (March 2007)

The last clarification is crucial in the context of data sharing and especially regarding cost-sharing.

In case of an only representative of several non-EU manufacturers and only one EU manufacturer, the cost would be shared as follow:

 2 actors:

50 % only representative50 % EU manufacturer (Legal Entity)

  This situation is unfair and would create an imbalance between EU manufacturer(s) and non-EU

manufacturers. Indeed, if behind the only representative there are 10 non-EU manufacturers (Legal entities), the sharing of costs according to Legal Entities should normally be (if the only representative would have represented only one non-EU Manufacturer):

 11 actors:

9.09 % by non-EU manufacturers, 90.9 % for the whole of NEM9.09 % for the EU manufacturers (Legal Entities)

  The question here is how to control that the only representative represents one Legal

Entity instead of several? What control mechanism will be possible at the stage of the pre-registration?

Moves of EU Companies: L’Oreal

• L'Oreal is extending its research and development capabilities in the area of reconstructed skin with the acquisition of the company SkinEthic through its subsidiary Episkin. The move will help it develop more accurate testing capabilities for a range of skin care products, particularly UV sunscreens.

• In line with EU objective outlined by the REACH programme, L'Oreal says that the ultimate goal is to develop a range of standardized in vitro methods that can be used to test ingredient safety with the aim of accelerating the elimination of animal testing.

Moves of Korea on Chemical Safety

화학물질 관련 연구 , 정책 및 규제 일자 기관유해화학물질 함유 제품의 소비자노출기법 적용 방안 2006 년 12 월 30 일 KEI

위해성평가의 대상물질 선정기준 , 절차 및 방법 등에 관한 지침 (국립환경과학원고시 제 2006-30 호 )

2007 년 1 월 10 일 NIER

소비자 노출평가기법 개발연구 ( ) (Ⅱ 국립환경과학원 공고 제 2007-74호 )

2007 년 4 월 4 일 NIER

4 개물질노출실태 조사 및 분석 , 국립환경과학원공고 제 2007-75 호 2007 년 4 월 4 일 NIER

제조나노물질의 위해성 평가를 위한 DB 구축 및 위해성 평가기술관련 연구 유해화학물질의 생태독성평가방법 개발 및 표준화

2007 년 1 월 NIER

OECD 대량생산 화학물질 위해성평가 2007 년 1 월 NIER

화학물질정보 통합시스템 구축 (III) 2007 년 1 월 NIER

GHS 에 의한 유독물 분류 · 표시 (III) 2007 년 1 월 NIER

화학물질의 분류 , 표시 및 물질안전보건자료에 관한 기준개정 ( 노동부고시 제2006-36 호 )

2006 년 12 월 12 일 MOLAB

화학물질 및 물리적인자의 노출기준 ( 고시 ) 일부 개정안 ( 노동부 공고 제 2007-65 호 )

2007 년 3 월 7 일 MOLAB

화학물질의 유해성심사 등에 관한 규정 ( 국립환경과학원 고시 제 2005-19 호 )

2006 년 1 월 6 일 NIER

GHS 체계 화학물질 유해 · 위험성 분류 및 경고표시정보 DB 시스템 2007 년 3 월 23 일 KOSHA

Conclusion

• Immediate Discussion with EU Companies and Consortia: Some Consortia open to Non-Community companies (KECE has discussed with Lead, Zinc, Cobalt and Nickel Consortia, respectively)

• Gap Analysis (i.e. what we have, what is required, what we need)• Learning by Doing (e.g. No previous experience in the HPV

program in the private sector)

Clear Commitment of CEOs & Resource Allocation to Practitioners

And…

Conclusion

Further Information: www.kece.eu, www.reachghs.eu

SACStandardizati

on Administratio

n of China

CNIS (China National Institute of Standardization)SPC (Standards Press of China)

CAS (China Association For Standardization)

CNAB (National Accreditation Board for Certifiers) CNAT (National Auditor & Training Accreditation Board) CNAL ( National Accreditation Board for Laboratories)

CCIC (China Certification & Inspection Group)

CQC (China Quality Certification Center)

CWTS (China Wireless Telecommunication Standards working Group)

NITS (National Information Technology Standardization Technical Committee)

CESI (China Electronics Standardization Institute

National Secretariat for JTC1 & IEC TC3/SC3D

CCSA (China Communication Standards Association)

MIIMinistry of Information

industry

NIM (National Institute of Metrology)

ITU

OIML

APLAC

PAC

IAF

ILAC

BIPM

International

WTO/SPS

WTO/TBT

APEC/SCSC

APMP

Regional

JTC1

IEC

PASC

AQSIQState

Administration of Quality

Supervision, Inspection and

Quarantine

ISO

FAO

Government

Non-Government

AGRIMinistry of AgricultureCodex

APLMF

CNCAAdministratio

n of Certification

& Accreditation

of China

Inquiry pointInternational Inspection and Quarantine

Standards and Technical Regulations Research Centre