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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
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