Download The Airbus Case on Chromium Trioxide

The Airbus Case on Chromium Trioxide and
Chromium Compounds
Maureen Wood
Major Accident Hazards Bureau
Outline of the Presentation
• Background and description of the question
concerning the new classification of CrO3 in
the 29th ATP to 67/548/EC
• Summary of Member State Comments on
the issue
• MAHB opinion and recommendation
• Current situation
Background – 29th ATP, Cr3 and Seveso
• The 29th ATP of the Dangerous Substances Directive
changes the classification of Chromium Trioxide (CrO3)
to “Very Toxic” from “Toxic”.
– This re-classification changes the Seveso thresholds for
CrO3 from 5 t to 20 t for and 50t to 200 t for upper and
lower tier coverage respectively.
• Cr3 is widely used in the electroplating industry and this
change could bring a large number of these sites into
the Seveso II Directive.
– One typical electroplating process involves the dissolution
of CrO3 in water (the “electroplating bath”).
– Included in this group are several Airbus sites across
Europe (e.g., the UK, France, Germany) that could become
upper tier sites as a result of this change.
Background – Airbus question
Following the finalisation of the 29th ATP,
Airbus posed the following questions to MS
with Airbus sites:
•
How should the new classification be interpreted in
terms of Seveso coverage of these electroplating
baths?
Background – HSE Questions
At CCA #14 in Buxton, the UK HSE tabled the
Airbus question and sought interpretation of
additional questions as follows:
•
•
•
•
•
What rules should be applied to these types of solutions?
What evidence is needed to provide confidence in the
chemical argument?
If we accept that CrO3 is not present, what evidence do we
need to establish what is?
What information do we want to determine the hazard
classification of the bath itself?
How far is the argument, and the information provided to
support it, extendable to other electroplating sites?
Background – Commission initiative
In response to the HSE request:
• DG-ENV invited the Member States to send their
opinions and observations concerning the issue to the
Commission in writing.
• DG-ENV asked MAHB to provide an opinion on the
Airbus question, taking into account all relevant
scientific and legal resources, including MS comments.
• The Commission agreed to provide a summary of the
results of these efforts to HSE by the end of November
2006.
Member State Comments - Action taken
• MS were asked to respond to HSE questions by
31 October 2005.
• DG-ENV received responses from 7 Member
States (B, D, DK, F, I, PL, S)
Member State Comments on Classification
What is it and how should it be classified?
The various opinions received are summarised below:
• If it is CrO3, the dilution rules are not applicable because
quantities are >7% (Preparation Directive 1999/45/EC),
i.e., it should be classified as “very toxic”.
• The substance in the baths is no longer Cr03. The new
substance is probably chromic acid (H2CrO4) which
exists in aqueous solutions. (So it cannot be considered
dilute CrO3 or a solution of Cr6+ ions.)
– H2CrO4 is a “chromium (VI) compound not explicitly listed
by name” in Annex 1 of Directive 67/548/EEC, currently
classified as “dangerous to the environment” but evidence
exists that it is very toxic.
Member State Comments on Testing
Classification and Testing
• Some indicated that if classification based on
components is not deemed appropriate, according to
1999/45/EC, a specific study to identify toxicological
aspects can be undertaken.
– Varying opinions as to the conditions that such tests could
be accepted in lieu of a generic classification (e.g., can the
operator decide or is it up to the competent authority?)
– Varying opinions on how test results should apply (uniquely
to Airbus or extendable to all electroplating baths?)
Member State Comments - Broader questions
The MS raised broader questions in their comments as
follows:
• Does this situation appropriately reflect the intended scope of
the Directive? The automatic links between the classifications
directives and Seveso should be reconsidered
• Are the concentration rules of the Preparations Directive valid
when there is a change in aggregation (solid to liquid)?
• The dilution rule of the Preparations Directive provides only a
rough estimate of toxicity. If Airbus is allowed to prove that
its preparation is non-toxic, will that not open the door for
other operators to do the same for other diluted substances?
• Are the dilution rules suitable for water-reacting substances?
• The Commission should take appropriate action to clarify the
classification of chromic acids under 67/548/EEC.
MAHB Opinion - Disclaimer
• Preliminary opinion pending further dialogue
with Member States, DG-ENV
• MAHB has no legal authority to interpret
implementation for MS. The Seveso II
Directive confers this authority on the
Member States.
MAHB Opinion – Central Questions
MAHB aimed to achieve the following
objectives in its opinion on this issue:
– investigate the scientific evidence
concerning the nature of the substance
– identify the outstanding questions regarding
the nature of the substance and its
hazardous properties
– identify options for answering these
questions under EU law
MAHB Opinion – Technical context
MAHB determined that the central questions of this
case are as follows:
1. On a scientific basis, what is the true identification,
of the chromium component of the electroplating
baths?
2. What is the correct application of Directives
67/548/EC and 1999/45/EC in determining the
classification of the composition contained in the
bath?
(In the case of substances and preparations which are not
classified as dangerous according to [67/548/EC and 99/45/EC],
… the procedures for provisional classification shall be followed in
accordance with the relevant article of the appropriate Directive.
[2003/105/EC])
MAHB Opinion – The Chromium Component
• The component is H2CrO4 (chromic acid)1 rather than a
preparation containing CrO3. It exists only in aqueous
solution.
• Therefore, it legally meets the criteria of a Substance
rather than a Preparation1, 2.
–Transformation into H2CrO4 occurs via a production process.
–The solvent (water) cannot be separated without affecting
stability.
1
CAS# 7738-94-5, EINECS# 231-801-5
2
“substances” means chemical elements and their compounds in the natural state
or obtained by any production process, including any additive necessary to
preserve the stability of the products and any impurity deriving from the process
used, but excluding any solvent which may be separated without affecting the
stability of the substance or changing its composition. [Directive 67/548/EC]
MAHB Opinion – Classification of Chromium
Component
• H2CrO4 is a substance not a preparation and therefore,
falls under the classification scheme of 67/548/EC.
• It is not currently classified as a separate substance in
Annex 1 67/548/EC.
• Therefore, in accordance with Annex 1, Part 2 of the
Seveso II Directive, the operator must investigate and
identify the risk classification of this substance applying
the criteria and procedures established in 67/548/EC.
MAHB Opinion – Classification as a Chromium
VI compound
– H2CrO4 is a Chromium VI compound
– Chromium VI compounds are currently classified in
Annex 1 of 67/548/EC as:
• R49 (May cause cancer by inhalation)
• R43 (May cause sensitization by skin contact)
• R50/53 (Very toxic to aquatic organisms/May cause
long-term adverse effects in the aquatic environment)
– However, a preliminary review of the most recent
literature on these compounds suggests an R26
classification (very toxic by inhalation):
• LC50 value of 0.217 ppm (< 0.250 ppm, the threshold for R26)
– For this reason we would not recommend using this
classification.
MAHB Opinion – Self-classification
• There are two alternatives for selfclassification
– Basing classification on a thorough review of all
available scientific data for Chromium VI compounds
– Conducting additional tests to verify the toxic
properties of H2CrO4 solutions
MAHB Opinion – Testing and test results under
67/548/EC
• Scientific evidence should conform with 67/548/EC
testing requirements
– Article VII describes the kinds of testing that are required
for analysing the different types of hazardous properties.
– Article V describes appropriate conditions for the various
tests (number of subjects, duration, temperature,
humidity, equipment standards, etc.). If there is a
deviation from these conditions, it must be justified.
• Generic conditions are important because:
– The provisions assume that the classification applies
generically to all sites in the Member State and across
Europe.
MAHB Opinion – Reaching agreement among MS
on classification
• Oversight of classification of substances
(outside Annex 1, 67/548/EC) is primarily a
responsibility of Member States.
• Operators and MS involved with a particular
substance are expected to co-ordinate in the
classification process
MAHB Opinion – Answers to UK questions (1)
• What rules should be applied to these types of solutions?
Under Seveso II, substance classification should follow as
closely as possible the logic and procedures described in
67/548/EC (substances) and 99/45/EC (preparations).
• What evidence is needed to provide confidence in the chemical
argument? If the nature of the composition have not already
been clearly described in the scientific literature, then it is the
duty of the operator to conduct appropriate tests to provide
this evidence. Annex V of 67/548/EC prescribes certain tests
to understand the physical and chemical properties of a
substance or preparation but additional tests may also be
recommended on a case-by-case basis.
MAHB Opinion – Answers to UK questions (2)
• If we accept that CrO3 is not present, what evidence do we
need to establish what is? In the Airbus case, the scientific
literature provides sufficient information to identify the
composition of the baths and no more evidence is needed.
•
What information do we want to determine the hazard
classification of the bath itself?
If Annex 1 or available
scientific data do not provide adequate guidance for the
substance/preparation in question, additional tests should be
undertaken to identify the hazardous properties in question.
Types of tests and testing conditions that are acceptable are
described Annex V 67/548/EC.
• How far is the argument, and the information provided to
support it, extendable to other electroplating sites?
67/548/EC assumes that classifications are generically
applicable to similar compositions on other sites.
MAHB Opinion - Recommendation
• Affected Member States should discuss the
available options and agree on a way
forward.
• Following this agreement, the MS may also
wish to request classification of H2CrO4 in
Annex 1 as a separate substance and a
review of the classification of Chromium VI
compounds (as part of a future ATP).
Current situation – MAHB Opinion
• Referred to DG-Environment on 11/16/2005
• Further consultation was conducted with DGEnvironment experts, ECB and MS
toxicologists
• Adopted formally by DG-Environment and
communicated to CCA on 07/12/05 with a
recommendation to affected Member States
• Member State decision is pending.
Current situation - Other outstanding issues
Broader questions raised by Member States:
1.
2.
Automatic link with the classifications directives
Appropriateness of concentration rules of the Preparations
Directive if a change in aggregation occurs
3.
Implications of Airbus case for other types of preparations
4.
Are the dilution rules suitable for water-reacting substances?
5.
Classification of chromic acids under 67/548/EEC
If these topics remain of high interest, options to
address them may be considered for further discussion.
Acknowledgements
The outcome of this work is the result of
contributions
from
many
individuals
including
colleagues
in
MAHB,
DGEnvironment,
the
European
Chemicals
Bureau and the Member States.
The quality of the input and collaboration has
been greatly appreciated.
Thank you for your attention.