D a v i d T h o m a s

U K L a w y e r

K e l l e r & H e c k m a n R E A C H w o r k s h o p

4 J u n e 2 0 1 4

Dow Chemicals: a turning-point?

European Coalition to End Animal Experiments

Member organisations in 22 Member States and other

European countries too

Opposed to animal experiments on ethical grounds and casts

a sceptical eye on the science

Heavily involved in REACH, gestation and practice

Accredited stakeholder at ECHA and observer at MSC and

RAC meetings, comments on to testing proposals

Intervened in four Board of Appeal cases: H on eyw ell, D ow

C h em icalsand L an xessand now C IN IC C h em icals

The Board of Appeal: part of ECHA

Article 76

“Th e A gen cy sh allcom prise:

(a) a M an agem en tB oard…

…

(e) a M em berS tate C om m ittee, w h ich sh allbe respon sible forresolvin gpoten tialdivergen cesof opin ion son draftdecision sproposed by th eA gen cy orth e M em berS tates

…

(g) a S ecretariat, w h ich sh all… provide tech n ical, scien tific an dadm in istrative supportforth e C om m ittees

(h ) a B oard of A ppeal, w h ich sh alldecide on appealsagain stdecision staken by th e A gen cy”.

The Board of Appeal: independence

Article 90

“2 . Th e m em bersof th e B oard of A ppealsh allbe in depen den t. In m akin g

th eirdecision sth ey sh alln otbe boun d by an y in struction s.

3 . Th e m em bersof th e B oard of A ppealm ay n otperform an y oth er

dutiesin th e A gen cy.

4 . Th e m em bersof th e B oard of A ppealm ay n otbe rem oved eith erfrom

office orfrom th e listdurin g th eirrespective term s, un lessth ere are

seriousgroun dsforsuch rem ovalan d th e C om m ission , afterobtain in g

th e opin ion of th e M an agem en tB oard, takesa decision toth iseffect.

5 . M em bersof th e B oard of A ppealm ay n ottake partin an y appeal

proceedin gsif th ey h ave an y person alin terestth erein , orif th ey h ave

previously been in volved asrepresen tativesof on e of th e partiesto th e

proceed in gs, orif th ey participated in th e decision un derappeal”.

The Board of Appeal: appointment and reappointment

Article 89(3)

“Th e C h airm an , th e oth erm em bersan d th e altern atessh allbe

appoin ted by th e M an agem en tB oard on th e basisof a listof

can didates proposed by th e C om m ission … [an d ] th eir relevan t

experien ce an d expertise in th e field of ch em icalsafety, n atural

scien cesorregulatory an d judicialprocedures… ”

Article 90(1)

“Th e term of office of th e m em bers of th e B oard of A ppeal,

in cludin g th e C h airm an an d th e altern atessh allbe five years. It

m ay be prolon ged on ce”.

Board of Appeal powers

Article 93(3)

“Th e B oard of A ppealm ay exercise an y pow erw h ich liesw ith in

th e com peten ce of th e A gen cy orrem itth e case to th e com peten t

body of th e A gen cy forfurth eraction ”.

Early BoA decisions

• First Appeals: administrative matters

• Decisions allowing ECEAE to intervene

• H on eyw ell

The decision in H on eyw ell

The substantive issue: were further studies appropriate under

col 2 of section 8.6.4 of Annex X (ECHA has a discretion)?

The decision:

(i) ECHA in breach of Article 25(1) (the last resort

principle); and

(ii) In any event, its decision was disproportionate

D ow C h em icals: the issue

Could data from the source substance, DPMA, be read across

to the target substance, PMA (the substance under

registration)?

Read-across is a way of avoiding tests, and in particular

animal tests

REACH and animal welfare

Article 13(1)

“In form ation on in trin sic propertiesof substan cesm ay be gen erated

by m ean soth erth an tests, provided th atth e con d ition ssetoutin

A n n ex X Iare m et. In particularforh um an toxicity, in form ation sh all

be gen erated w h en ever possible by m ean s oth er th an vertebrate

an im altests, th rough th e use of altern ative m eth ods, forexam ple, in

vitro m eth ods or qualitative or quan titative structure-activity

relation sh ip m odelsorfrom in form ation from structurally related

substan ces(groupin gorread-across)… ”

REACH and animal welfare (1)

Article 25(1)

“In order to avoid an im al testin g, testin g on vertebrate

an im alsforth e purposesof th isRegulation sh allbe un dertaken

on ly asa lastresort. Itisalso n ecessary to take m easures

lim itin gduplication of oth ertests”.

Article 30

Duty to share data from animal tests

REACH and animal welfare (2)

Introduction to the testing annexes

Can adapt column 1 requirements under column 2 or Annex XI

“B efore n ew testsare carried outto determ in e th e propertieslisted in th isA n n ex, allavailable in vitro data, in vivo data,h istoricalh um an data, data from valid (Q )S A Rsan d data fromstructurally related substan ces(read-acrossapproach ) sh allbeassessed first…”

REACH and animal welfare (3)

All in the context of Article 1:

“1 . Th e purpose of th is Regulation is to en sure a h igh level of

protection of h um an h ealth an d th e en viron m en t, in cludin g th e

prom otion of altern ative m eth ods for assessm en tof h azards of

substan ces, as w ell as th e free circulation of substan ces on th e

in tern alm arketw h ile en h an cin gcom petitiven essan d in n ovation .

2 . …

3 . Th is Regulation is based on th e prin ciple th at it is for

m an ufacturers, im portersan d dow n stream userstoen sure th atth ey

m an ufacture, place on th e m arketoruse such substan cesth atdon ot

adversely affecth um an h ealth orth e en viron m en t. Itsprovision sare

un derpin n ed by th e precaution ary prin ciple”.

What is read-across?

Paragraph 1.5 of Annex XI

“Groupin gof substan cesan d read-acrossapproach

S ubstan ces w h ose ph ysicoch em ical, toxicologicalan d ecotoxicological

propertiesare likely tobe sim ilarorfollow a regularpattern asa result

of structuralsim ilarity m ay be con sidered asa group, or“category” of

substan ces. A pplication of th e group con cept required th at

ph ysicoch em icalproperties, h um an h ealth effects an d en viron m en tal

effectsof en viron m en talfate m ay be predicted from data forreferen ce

substan ce(s) w ith in th e group by in terpolation tooth ersubstan cesin th e

group (read-across approach ). Th is avoids th e n eed to testevery

substan ce forevery en dpoin t… ”

What is read-across? (2)

Paragraph 1.5 of Annex XI (contd.)

“Th e sim ilaritiesm ay be based on :

1 ) a com m on fun ction algroup;

2 ) th e com m on precursorsan d/ orth e likelih ood of com m on breakdow n

productsvia ph ysicalan d biologicalprocesses, w h ich resultin

structurally sim ilarch em icals; or

3 ) a con stan tpattern in th e ch an gin gof th e poten cy of th e properties

acrossth e category.

If th e group con ceptisapplied , substan cessh allbe classified an d labelled

on th isbasis”.

What is read-across? (3)

Paragraph 1.5 of Annex XI (contd.)

“In allcasesresultssh ould:

-be adequate forth e purpose of classification an d labellin g an d/ orrisk

assessm en t

-h ave adequate an d reliable coverage of th e key param etersaddressed

in th e correspon din gtestm eth od referred toin A rticle 1 3 (3 )

-cover an exposure duration com parable to or lon ger th an th e

correspon din g testm eth od referred to in A rticle 1 3 (3 ) if exposure

duration isa relevan tparam eter, an d

-adequate an d reliable docum en tation of th e applied m eth od sh allbe

provided”

D ow : particular issues

Rate of hydrolysis: common breakdown route

Read-across accepted for 90-day endpoint but not PNDT: does

this make sense?

Does it matter whether data from source substance was negative

or positive?

Relevance of OECD acceptance of the read-across for PNDT

The approach to similarity

Possible judicial approaches

Review: e.g. European courts

Rehearing or de n ova

How the BoA saw its role in Honeywell

“H ow ever, in relation to th e ‘m an ifestly in appropriate’ criterion setby th e EUC ourtsw h en con ductin g a judicialreview of th e proportion ality of a m easure,th e B oard of A ppealun derlin esth e cleardifferen cesbetw een itself an d th e EUC ourts. In particular, th e latterrefrain from substitutin g th eirow n assessm en tforth atof th e EU in stitution w h ose decision isbein g review ed … H ow ever, un derA rticle 9 3 (3 ) of th e REA C H Regulation , th e B oard of A ppeal“m ay exercise an ypow erw h ich liesw ith in th e com peten ce of th e A gen cy [… ]”. Th us, th e B oard ofA ppealcan in teralia replace a decision un derappealsw ith a differen tdecision .M oreover, in con ductin g its adm in istrative review of A gen cy decision s, th eB oard of A ppealpossessescertain tech n icalan d scien tific expertise w h ich allow sittoen terfurth erin toth e tech n icalassessm en tm ade by th e A gen cy th an w ouldbe possible by th e EU C ourts. A sa result, w h en exam in in g w h eth era decisionadopted by th e A gen cy isproportion ate, th e B oard of A ppealcon sidersth atitsh ould n otbe lim ited by th e n eed to establish th atth e decision is“m an ifestlyin appropriate” toth e objective pursued” (em ph asisadded).

D ow : the general approach of the BoA

“Th e A gen cy … h as broad discretion … [th e com plian ce ch eck]en tailed assessm en tof com plex scien tific an d tech n icalfacts... Th eA gen cy’s discretion ary pow ers h ave also been recogn ised by th eC ourtof Justice of th e European Un ion w h ich h ash eld th at‘[… ] th eA gen cy h asa broad discretion in a sph ere w h ich en tailspolitical,econ om ic an d socialch oiceson itspart, an d in w h ich itiscalled uponto un dertake com plex assessm en ts’ (see C ase C -1 5 / 1 0 Etim in e S A ,judgm en tof 2 1 July 2 0 1 1 )… ”

The opposite of what it said in H on eyw ell

D ow : the general approach of the BoA (2)

“Th e B oard of A ppealn otesth atth e A ppellan th asn otm an aged toadequately rebutth e factth atits read-across proposal for th een dpoin ton pre-n atal developm en tal toxicity con tain s a level ofun certain ty con sidered tobe un acceptable by th e A gen cy.”

a virtually insurmountable hurdle

BoA did say it would interfere if all relevant factors nottaken into account

Which is the correct approach?

The H on eyw ellapproach is right:

Technical expertise

Article 93(3)

Etim in e and Rutgerswere direct challenges from the decision-

maker to an European court

N V Elektriceits, H en keland Article 12(1) of the procedure

regulation

D ow : BoA findings

Hydrolysis not sufficiently rapid

Article 25(1), the last resort provision, imposes no additional

duties

OECD decision distinguishable

Rejected Dow’s arguments that ECHA should have explained

differing approaches to the 90-day endpoint and PNDT

D ow : no clear findings

Negative/positive data issue

Read-across accepted for one endpoint but not another

Test posed by ECHA: “W h en th ere isun certain ty on a proposed

w ay to satisfy an in form ation n eed resultin g from th e REA C H

A n n exesV IItoX , EC H A asa regulatory body n eedstorequestth e

in form ation type w h ich prom ises to resultin less un certain ty.

EC H A doesn oth ave discretion in th isrespect.”

The similarity issue: no proper explanation why a really strong

read-across was rejected; Article 1(3)

The approach in M om en tive

Burden is on registrant to demonstrate appropriateness of read-

across

Question BoA asked still not correct: was ECHA justified in

concluding that the Appellant had failed to establish structural

similarity between source and target substances/ similarity of

properties?

L an xess: the issue

Is a second species PNDT study mandatory at Annex X (subject to

column 2 and Annex XI adaptation)?

Col 2 of section 8.7.2 (developmental toxicity) and 8.7.3

(reproductive toxicity) of Annex IX:

“Th e study sh allbe in itially perform ed on on e species. A

decision on th e n eed toperform a study atth iston n age level

or th e n exton a secon d species sh ould be based on th e

outcom e of th e firsttestan d all oth er relevan tavailable

data.”

Col 1 of section 8.7.2 and 8.7.3 Annex X refers to one species

L an xess: the decision

Second species study is mandatory at Annex X (subject to

column 2 and Annex XI adaptation)

Makes no sense either linguistically or in policy terms

ECEAE appealing to General Court

The future

It is essential for public confidence – chemical companies,stakeholders and the general public – that:

the BoA understands the role of boards of appeal and how it

differs from that of the EU courts

is willing rigorously to examine ECHA decisions, legally and

scientifically, and, in appropriate cases, overturn them