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: Honeywell, Dow

Chemicals and Lanxess and now CINIC Chemicals

The Board of Appeal: part of ECHA

Article 76

“The Agency shall comprise:

(a) a Management Board…

…

(e) a Member State Committee, which shall be responsible for resolvingpotential divergences of opinions on draft decisions proposed by theAgency or the Member States

…

(g) a Secretariat, which shall…provide technical, scientific andadministrative support for the Committees

(h) a Board of Appeal, which shall decide on appeals against decisionstaken by the Agency”.

The Board of Appeal: independence

Article 90

“2. The members of the Board of Appeal shall be independent. In making

their decisions they shall not be bound by any instructions.

3. The members of the Board of Appeal may not perform any other

duties in the Agency.

4. The members of the Board of Appeal may not be removed either from

office or from the list during their respective terms, unless there are

serious grounds for such removal and the Commission, after obtaining

the opinion of the Management Board, takes a decision to this effect.

5. Members of the Board of Appeal may not take part in any appeal

proceedings if they have any personal interest therein, or if they have

previously been involved as representatives of one of the parties to the

proceedings, or if they participated in the decision under appeal”.

The Board of Appeal: appointment and reappointment

Article 89(3)

“The Chairman, the other members and the alternates shall be

appointed by the Management Board on the basis of a list of

candidates proposed by the Commission…[and] their relevant

experience and expertise in the field of chemical safety, natural

sciences or regulatory and judicial procedures…”

Article 90(1)

“The term of office of the members of the Board of Appeal,

including the Chairman and the alternates shall be five years. It

may be prolonged once”.

Board of Appeal powers

Article 93(3)

“The Board of Appeal may exercise any power which lies within

the competence of the Agency or remit the case to the competent

body of the Agency for further action”.

Early BoA decisions

• First Appeals: administrative matters

• Decisions allowing ECEAE to intervene

• Honeywell

The decision in Honeywell

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

Dow Chemicals: the issue

Could data from the source substance, DPM, be read across to

the target substance, DPMA (the substance under registration)?

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

tests

REACH and animal welfare

Article 13(1)

“Information on intrinsic properties of substances may be generated

by means other than tests, provided that the conditions set out in

Annex XI are met. In particular for human toxicity, information shall

be generated whenever possible by means other than vertebrate

animal tests, through the use of alternative methods, for example, in

vitro methods or qualitative or quantitative structure-activity

relationship models or from information from structurally related

substances (grouping or read-across)…”

REACH and animal welfare (1)

Article 25(1)

“In order to avoid animal testing, testing on vertebrate

animals for the purposes of this Regulation shall be undertaken

only as a last resort. It is also necessary to take measures

limiting duplication of other tests”.

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

“Before new tests are carried out to determine the propertieslisted in this Annex, all available in vitro data, in vivo data,historical human data, data from valid (Q)SARs and data fromstructurally related substances (read-across approach) shall beassessed first…”

REACH and animal welfare (3)

All in the context of Article 1:

“1. The purpose of this Regulation is to ensure a high level of

protection of human health and the environment, including the

promotion of alternative methods for assessment of hazards of

substances, as well as the free circulation of substances on the

internal market while enhancing competitiveness and innovation.

2. …

3. This Regulation is based on the principle that it is for

manufacturers, importers and downstream users to ensure that they

manufacture, place on the market or use such substances that do not

adversely affect human health or the environment. Its provisions are

underpinned by the precautionary principle”.

What is read-across?

Paragraph 1.5 of Annex XI

“Grouping of substances and read-across approach

Substances whose physicochemical, toxicological and ecotoxicological

properties are likely to be similar or follow a regular pattern as a result

of structural similarity may be considered as a group, or “category” of

substances. Application of the group concept required that

physicochemical properties, human health effects and environmental

effects of environmental fate may be predicted from data for reference

substance(s) within the group by interpolation to other substances in the

group (read-across approach). This avoids the need to test every

substance for every endpoint…”

What is read-across? (2)

Paragraph 1.5 of Annex XI (contd.)

“The similarities may be based on:

1) a common functional group;

2) the common precursors and/ or the likelihood of common breakdown

products via physical and biological processes, which result in

structurally similar chemicals; or

3) a constant pattern in the changing of the potency of the properties

across the category.

If the group concept is applied, substances shall be classified and labelled

on this basis”.

What is read-across? (3)

Paragraph 1.5 of Annex XI (contd.)

“In all cases results should:

-be adequate for the purpose of classification and labelling and/or risk

assessment

-have adequate and reliable coverage of the key parameters addressed

in the corresponding test method referred to in Article 13(3)

-cover an exposure duration comparable to or longer than the

corresponding test method referred to in Article 13(3) if exposure

duration is a relevant parameter, and

-adequate and reliable documentation of the applied method shall be

provided”

Dow: 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 nova

How the BoA saw its role in Honeywell

“However, in relation to the ‘manifestly inappropriate’ criterion set by the EUCourts when conducting a judicial review of the proportionality of a measure,the Board of Appeal underlines the clear differences between itself and the EUCourts. In particular, the latter refrain from substituting their own assessmentfor that of the EU institution whose decision is being reviewed… However, underArticle 93(3) of the REACH Regulation, the Board of Appeal “may exercise anypower which lies within the competence of the Agency […]”. Thus, the Board ofAppeal can inter alia replace a decision under appeals with a different decision.Moreover, in conducting its administrative review of Agency decisions, theBoard of Appeal possesses certain technical and scientific expertise which allowsit to enter further into the technical assessment made by the Agency than wouldbe possible by the EU Courts. As a result, when examining whether a decisionadopted by the Agency is proportionate, the Board of Appeal considers that itshould not be limited by the need to establish that the decision is “manifestlyinappropriate” to the objective pursued” (emphasis added).

Dow: the general approach of the BoA

“The Agency … has broad discretion … [the compliance check]entailed assessment of complex scientific and technical facts ... TheAgency’s discretionary powers have also been recognised by theCourt of Justice of the European Union which has held that ‘[…] theAgency has a broad discretion in a sphere which entails political,economic and social choices on its part, and in which it is called uponto undertake complex assessments’ (see Case C-15/10 Etimine SA,judgment of 21 July 2011)…”

The opposite of what it said in Honeywell

Dow: the general approach of the BoA (2)

“The Board of Appeal notes that the Appellant has not managed toadequately rebut the fact that its read-across proposal for theendpoint on pre-natal developmental toxicity contains a level ofuncertainty considered to be unacceptable by the Agency.”

a virtually insurmountable hurdle

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

Which is the correct approach?

The Honeywell approach is right:

Technical expertise

Article 93(3)

Etimine and Rutgers were direct challenges from the decision-

maker to an European court

NV Elektriceits, Henkel and Article 12(1) of the procedure

regulation

Dow: 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

Dow: no clear findings

Negative/positive data issue

Read-across accepted for one endpoint but not another

Test posed by ECHA: “When there is uncertainty on a proposed

way to satisfy an information need resulting from the REACH

Annexes VII to X, ECHA as a regulatory body needs to request the

information type which promises to result in less uncertainty.

ECHA does not have discretion in this respect.”

The similarity issue: no proper explanation why a really strong

read-across was rejected; Article 1(3)

The approach in Momentive

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?

Lanxess: 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:

“The study shall be initially performed on one species. A

decision on the need to perform a study at this tonnage level

or the next on a second species should be based on the

outcome of the first test and all other relevant available

data.”

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

Lanxess: 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