2 0 1 4 I N V E S T O R D A Y

REACH EVALUATION WORKSHOP

Dossier and Substance Evaluation and the ECHA Board of AppealBrussels, 4 June 2014

Caroline Ciuciu, EU Public Affairs DirectorAlbemarle Europe SPRL

• Introduction to Albemarle

• REACH within Albemarle

• How did Albemarle get engaged in REACH Evaluation?

• How does Albemarle view Dossier & Substance Evaluation?

• Our constructive and dynamic approach to Substance Evaluationbased on our previous experience and experience with the ExistingSubstances Regulation (ESR)

• How does Albemarle interpret the role of the Board of Appeal?

• Key considerations before going to the Board of Appeal

• Conclusions

Contents

Albemarle is a global provider of specialty chemicals

• A specialty chemicals company ofAmerican parentage with a strong EUpresence

• Over 3,900 employees around theworld, over 1,100 in Europe

• Over 3,400 customers in 100 countries

• 45 facilities, encompassing production,Research & Technology facilities, andadministrative offices in North and SouthAmerica, Europe, the Middle East andAsia

• Two global business units (GBU):

» Catalyst Solutions - 2013 Net Sales:

$1 Billion

» Performance Chemicals - 2013 Net Sales:$1.4 Billion

Introduction to Albemarle

Weifang City, China

Beijing, China

Magnolia, AR, USA

Tyrone, PA, USA

Baton Rouge, LA, USA

Orangeburg, SC, USA

Pasadena, TX, USA

Twinsburg, OH, USA

South Haven, MI, USA

Bayport, TX, USA

Santa Cruz,Brazil

Amsterdam,The Netherlands

Safi, Jordan Niihama, Japan

St. Jakob/Breitenau, Austria

Shanghai, China

Seoul, Korea

Louvain-la-Neuve, Belgium

Singapore

Tokyo, Japan

Osaka, Japan,

Zhejiang Province, China

Ningbo, China

Moscow, Russia

Doncaster East VIC,Australia

Al-Jubail,Saudi Arabia

Bergheim,Germany

Houston, TX, USA

Budapest, Hungary

Dubai, UAE

Regional/Sales Office

Manufacturing

R&D

Corporate Headquarters(Baton Rouge, LA, USA)

Joint Venture

St. Jakob/Breitenau, Austria

Shared Services Center

Safi, Jordan

Dalian, China

Yeosu, South Korea

Cambridge, UK

La Voulte, France

A global company with a strong EU presence

REACH within Albemarle

• A challenging but privileged situation:

» We are a manufacturer, an importer and a downstream user (depending on the substance andactivity)

» We manufacture and/or use organic and inorganic substances

• Fully engaged in the Registration process since the entry into force of REACH:

» 81 substances currently registered

» Lead Registrant for 18 substances

• Actively participating in the Authorization & Restriction processes:

» Participation in public consultations as manufacturer and/or DU

• Actively engaged in the REACH consortia and also WG of several TradeAssociations (CEFIC, Eurometaux, Essenscia, VCI, VNCI, etc) and national REACHfora

5

How did we get engaged in REACH Evaluation?

6

Dossier Evaluation Substance Evaluation

• Compliance checks:

» Draft Decisions were received for a smallnumber of our dossiers followingtargeted compliance checks

» Findings were mostly formal andresolved with dossier updates

» One pending dossier: testing required byECHA; Decision-making process is on-going

• Evaluation of testing proposals:

» Testing proposals made in ourregistration dossiers were generallyaccepted – sometimes with modificationsby ECHA and we have or are performingthe studies

• Two of the products that we manufacture(and/or import) were listed in the firstCoRAP on February 2012 (to be evaluatedfrom 2012 onwards by two differenteMSCA):

» MSC-34 hearing on 4 February on EBP

Unanimous agreement. Finaldecision very recently notified toregistrants.

» Decision-making process on Silicondioxide/synthetic amorphous silica is on-going

• Additional substance was listed in the 2014CoRAP to be evaluated from 2014 onwardsby a third eMSCA

How do we view Dossier Evaluation?

• Compliance check:» We are committed to up-date and continuously improve our dossiers

» Compliance checks provided completeness and quality assurance

» Lessons can be drawn for other registration dossiers (substance identity, read-acrossapproach, waivers, etc.)

» ECHA’s IT-driven completeness checks may miss information present elsewhere in the dossier

» Updates of the software may lead to formal compliance issues

» ECHA has a wide margin of discretion and does not communicate with industry during DE if no“QOBL”

» Communication before draft decisions are issued may solve some misunderstandings

• Approval of testing proposals:» Formal process to ensure studies are not duplicated

» Discuss and clarify testing strategies, in particular on read-across

How do view Substance Evaluation?

• Part of the new EU Risk Assessment process has generated expectations from industry:» Clarify methodological/conceptual issues of generic nature» Focus on risk-related considerations» Thorough analysis of different options available to manage identified risks, if any

• At Albemarle, we are committed to generating relevant data and performing additional testingrelated to our products to clarify the potential hazard or risk of marketed products and addresspotential concerns

• The process allows for some interaction with MS, MSC and ECHA according to a set of formalrules

• Precedent setting for other substances on CoRAP

• Development of a new process to find the right balance between basic scientific researchrequirements and regulatory compliance:

» Article 46 § 1 of REACH – SE may go beyond standard information requirements of AnnexesVII to X

» Some standard test methodologies can be substantially modified, while new methodologiesare being prescribed without existing guidance on how the results of this new testing will beevaluated

» Some technical/scientific challenges and regulatory uncertainty for registrants

eMSCA

OtherMSCA,

ECHA andMCS

Value ChainCo-

registrants

Dynamic approach to SE based on our previous experience with ESR

• Promoting a constructivescientific discussion = RiskAssessment under development

• Ensuring consistent decisions iskey for a level playing field=precedent setting process

• Keep value chain membersinformed and make theprocess as transparent aspossible for them

• CoRAP is not anotherBlacklist!

• Managing smooth & cooperativecommunication as early aspossible

• Securing a dialog on the testdesign and progress during thetesting phase

• Close contacts had provenbeneficial under the ESR

• Getting organized toefficiently contribute to theformal decision-makingprocess

• Time is short & timing isstrict!

• Speak with one voice!

How do we interpret the role of the Board of Appeal?

• An additional and innovative ‘quasi-judicial‘ step to ensure that fundamental legal &scientific principles of the Evaluation process and EU law are properly andharmoniously implemented:

» Unique opportunity to reverse or modify ECHA’s decision on scientific/technical grounds,which are usually not considered by the European Union Courts (‘broad discretion of theAgency’ ) and to substitute their own assessment to ECHA’s

» Additional opportunity to set ‘stepping-stones’ on scientific/technical issues:

Because they have ‘certain technical and scientific expertise’ (Decision of the BoA, 29April 2013, Honeywell § 117), Board of Appeal is part of the process like eMSCA, otherMSCA, ECHA and the MSC

EU Risk Assessment continues to develop in a dynamic way:

Unprecedented studies in regulatory toxicology or environmental assessmentneed to be appropriately scientifically designed and must generate informationthat is meaningful in a regulatory context

• Board of Appeal has and should contribute to ensuring that the New EU RiskAssessment procedure develops in a scientifically meaningful, fair, robust andefficient way.

Key considerations before going to the Board of Appeal

• Intrinsic content of the decision for a particular substance: Final decisions must bemeaningful, proportionate to the objectives and consistent with EU law.

» Relevancy of the test substance/material selection and testing requirements

» ‘Harmonized’ meaningful scientific testing requirements & harmonized robustinterpretations of protocols

» Proportionality of testing requirements to the legitimate objectives of theEvaluation (minimize animal testing, optimize protocols, stepwise/tiered approachof the testing strategy, etc.)

» Allocation of a reasonable period of time to conduct the testing

» Ensuring testing requirements are compatible with fair competition.

• Potential to set the tone for subsequent evaluations of similar substances

Conclusions

REACH Evaluation (especially SE) is an intensive and strictly formalized process with the objective ofresolving questions relating to concerns for human health and/or the environment & from which industryhas expectations (methodologies & protocols clarification, generic interpretation, etc.).

At Albemarle, we are committed to generating relevant data & perform extra testing related toour products to clarify the potential hazard or risk of marketed products & address potential concerns.

We are engaged in the process in a cooperative & dynamic way with the various relevantstakeholders.

A constructive scientific & technical discussion on generic principles and concepts of EU RiskAssessment needs to be pursued as a heritage of the ESR. Need for an open forum for in-depthdiscussion and consensus building between MS experts, ECHA and registrants on a technical level.

The Board of Appeal has an unprecedented and somehow unique role of ensuring that the new EU RiskAssessment procedure develops in a scientifically meaningful, fair, robust and efficient way.

Thank you for your attention,

Happy to answer questions

Caroline Ciuciu

EU Public Affairs Directorcaroline.ciuciu@albemarle.com

+32 10 48 17 15