The Council Common Position
& chemicals of ‘equivalent
concern’
April 2006
WWF position on how to include chemicals of
‘equivalent concern’ in Authorisation (article 54(f))
This briefing:
 Explains our concern with the Council Common Position wording for chemicals of ‘equivalent
concern’
 Proposes the European Parliament’s position on article 54(f) as an appropriate solution
 Provides 3 examples – Phthalates, Bisphenol A and Deca-BDE – to illustrate why the Council
Common Position wording is inadequate
Controlling chemicals with endocrine disrupting properties and vPvB chemicals (which are
not identified using the classical test methods) under REACH
WWF is very concerned about the wording of Article 54(f) in the Council Common Position. This
enables the following chemicals to be subject to prior authorisation:
“substances, such as those having endocrine disrupting properties or those having persistent,
bioaccumulative and toxic properties or very persistent and very bioaccumulative properties,
which do not fulfil the criteria of points (d) to (e) and for which there is scientific evidence of
probable serious effects to humans or the environment which give rise to an equivalent level
of concern to those of other substances listed in points (a) to (e) on a case by case basis in
accordance with the procedure set out in Article 56.”
However, unfortunately this text does not adequately address the growing concerns related to
chemicals with endocrine disrupting properties. Furthermore, for vPvB chemicals which will not be
identified by the classical test methods for persistence and bioconcentration, it would require animal
tests in order to provide scientific evidence that serious effects were probable. Such a requirement
for animal testing would mean that these ‘non-classical’ vPvB chemicals will not be treated in an
equivalent manner to the vPvBs identified by the Annex XII criteria, and moreover would result in
unnecessary animal suffering. As an example, perfluorinated chemicals, such as PFOS which
accumulates by binding to blood proteins, would not have been detected in the octanol-water
partition test, which identifies chemicals that bioaccumulate in lipids. However, PFOS is certainly
exceedingly persistent and bioaccumulates in organisms to a high degree.
The problems with the Council Common Position text in relation to its ability to control endocrine
disrupting chemicals and ‘non-classical’ vPvBs are detailed below. The alternative better option is
the text preferred by the European Parliament.
It is certainly without doubt a good thing that chemicals with endocrine disrupting properties should
be subject to authorisation, as it will enable tighter controls, as well as the gathering of good
information on the uses of such chemicals and therefore exposures. However, unfortunately, the
Council Common Position requires too high a level of evidence to be provided prior to bringing
these substances under authorisation, such that it would likely mean that effects on wildlife or the
humans would not be prevented.
WWF is concerned about the wording ‘probable serious effects’ because it implies that such
chemicals could only be subject to authorisation when serious effects were the most likely scenario,
and as such were deemed more likely than not. It suggests that there would have to be more than
50% chance of serious effects. To limit the possible use of precautionary action in this way would
not necessarily be cost effective, as it circumvents any consideration of the potential costs of
inaction, as compared with the costs of action.
Another unfortunate consequence of this wording is that it would unnecessarily open up the door to
legal challenges from industry, and could result in the regulatory authorities having to show that
serious effects were probable, before a chemical with endocrine disrupting properties or PB(T)
properties could be drawn under authorisation.
Furthermore, the text does not give due consideration to the fact that many endocrine disrupting
chemicals, frequently found as contaminants, can certainly act in an additive manner.
WWF considers that Member States must ensure that chemicals with endocrine disrupting
properties can be brought under prior authorisation if there is sufficient scientific evidence to show
they might contribute to serious effects to humans or wildlife.
Alternative option to the Council text for 54(f)
WWF fully supports the Parliament’s text, which mirrors both the earlier proposals of Sweden and
Poland, and the original text of REACH (of May 2003) which the Commission published on the
internet as a consultation text. Furthermore, the Commission accepted in principle the Parliament’s
amendment.
The Parliament’s text requires a lower burden of proof, and requires that the additional substances
which could be drawn into authorisation, such as those with endocrine disrupting properties, are
identified “as giving rise to a similar level of concern” as the other substances listed.
This would provide a robust framework to enable the EU to deal effectively with unforeseen
concerns that may arise in relation to chemicals in the future. Furthermore, it is workable, because it
would be for the Member State Committee to weigh those concerns, and such a committee will not
act against a chemical without the concerns being well-founded. As Denmark has pointed out, the
number of chemicals brought under prior authorisation would anyway be limited by the system’s
capacity. Moreover, it should be noted that bringing a chemical under prior authorisation does not
result in an overnight ban, but it does serve to identify the uses of that chemical, and to subject these
to strict regulatory oversight.
WWF considers that Article 54(f) must serve as a safety net to bring worrisome chemicals,
particularly those with endocrine disrupting properties, under strict control, in advance of harm
actually occurring in humans or wildlife. The prior authorisation procedure is the preferred
mechanism for imposing precautionary controls, because unlike the restrictions process, it puts the
burden of proof entirely on industry, such that industry itself must make the case for continued use.
There are other important grounds for advocating a return to the text which only required ‘a similar
level of concern’. For example, it needs to be recognised that 54(f) also relates to very persistent
and very bioaccumulating compounds, that do not meet the Annex XII PBT criteria. For such
substances, there should not be a requirement to have any scientific evidence of effects, as the
undesirable properties of high persistence and high bioaccumulation should suffice to warrant them
being brought under prior authorisation, as is the case with the Annex XII vPvB chemicals. To
require even some evidence of serious effects for such chemicals would likely result in unnecessary
testing on animals.
Examples of chemicals with endocrine disrupting properties or potential developmental
neurotoxic properties that would not be caught by the Council text
Bisphenol A case study
Bishenol A (BPA) is a chemical with known estrogenic properties. However, it would not yet be
able to be subjected to authorisation if the Council Common Position text was accepted, and
‘probable’ was interpreted to mean more likely than not. Thus, BPA provides an illustration of a
chemical, which WWF considers is of very high concern, but which would not be able to be drawn
under authorisation.
BPA does not meet the criteria for a PB(T) chemical, nor those for a reproductive toxin category 1
or 2 (R1 or R2). However, with regard to its reproductive toxicity, there are good grounds for
concern. Indeed, Member States finally decided it should be classified as R3, but this decision was
far from unanimous, with several Member States including the UK, arguing that it should be R2.
Evidence is mounting on the possibility of low dose effects due to bisphenol A. It is now well
known that it has the ability to mimic oestrogen in several animal species. Indeed, WWF would
argue that such evidence of oestrogenicity, by itself, should be sufficient to warrant action to
eliminate or at least reduce exposure. This is because it is now known that chemicals with
estrogenic properties can act additively in animals.i Any effects actually occurring in the real world
would therefore likely be due to many chemicals acting together, and this makes any regulatory
necessity to show “probable” effects due to exposure to just one chemical, far too onerous.
If effects were considered to be “probable” – that is more likely than not - then this chemical would
already have been acted on under the Existing Substances Regulation. At the time it was assessed,
there were conflicting studies, and the experts of the Member States put more weight on the studies
which did not find effects. It could therefore be said that the scientific experts of Member States
considered that adverse effects were not more likely than not. However, these scientific experts did
consider that effects were possible, and therefore required more studies to explore this possibility.
WWF would argue that not enabling such chemicals to be subject to authorisation, does not provide
an adequately precautionary basis for regulation. It should be noted that authorisation is not
necessarily a restriction, it could just provide information on where the chemical is being used and
in what circumstances. Moreover, what if, for example, the scientific experts of the Member States
considered there was only a relatively small possibility that certain particular studies were valid and
meant that adverse effects would occur? Yet if such effects did occur, they could likely still affect
thousands of babies in the population. Surely, in such a circumstance, it would make sense to bring
such a chemical under authorisation, on the basis of possible effects. This would ensure that the
regulatory authorities would know who was using the chemical and all its end uses. Then when it
came to the decision on whether or not to grant an authorisation, it would make sense to at least
consider the potential costs of inaction on the chemical as compared to the costs of taking action.
For example, if the costs of not authorising such a chemical was low for some uses which gave rise
to high exposure, perhaps because there was a safer alternative which was only marginally more
expensive, and the costs of not taking action was potentially very high – then surely it would make
sense to at least enable such regulatory action?
The science suggesting adverse effects due to bisphenol A is growing. However, many of the new
studies are not traditional regulatory test methods, and therefore it is difficult for these to be judged
as definitive when the standard regulatory tests have not found effects. Nevertheless, several studies
suggest low doses in the womb can cause effects on the developing prostate gland, and although
some of these studies have been disputed, the number of studies finding low dose effects is steadily
growing.ii One important recent study suggests it can cause changes in mammary gland tissue that
might result in an increased risk of breast cancer.iii In addition, small epidemiological studies in
Japan have also suggested bisphenol A might be implicated in an increased risk of miscarriage, iv
and in polycystic ovary disease.v However, it seems regulatory agencies do not yet consider these
studies supply adequate proof of a causal link. Nevertheless, in order to prevent effects, it could be
argued that there will be a need to act in advance of scientific evidence for probable effects in
humans or wildlife. To have to wait until effects are judged to be more likely than not to occur, can
hardly be considered to be adequately precautionary. To protect the unborn child, surely it is better
to be safe rather than sorry?
Such a precautionary way forward has been endorsed by the scientific community. The Prague
Declaration from May 2005 (see http://www.edenresearch.info/declaration.html) has been signed by
over 100 international scientists working at the cutting edge of research into EDCs. It highlights the
serious concerns about endocrine disrupting chemicals. This Declaration presses for precautionary
action and states, “In view of the magnitude of the potential risks associated with endocrine
disrupters, we strongly believe that scientific uncertainty should not delay precautionary action on
reducing the exposures to and the risks from endocrine disrupters”. Thus, not to ensure adequate
precautionary action can be taken would fly in the face of the best scientific evidence.
Phthalate case study
Certain phthalates have been clearly shown to have anti-androgenic action in laboratory
experiments. Therefore, concerns have been raised about their effects on male reproductive health,
and their possible role in contributing to low sperm counts and un-descended testicles. As the
evidence mounts, the need to act increases. It could certainly be argued that action will be required
(a) before there is certainty that phthalates are responsible and (b) before there is complete
agreement by everyone that the effects are serious. Pressure is certainly increasing for a
precautionary approach to be adopted in order to reduce exposure levels.
The Council Common Position would not deliver a way forward in a situation like this, and would
result in on-going exposure of the foetus in the womb. The Council Common Position does not
provide a legislative framework that enables precautionary action. Put simply, it does not support a
‘better safe than sorry’ approach.
Around 25 years ago, researchers knew that certain phthalates affected the function of the testes,
and by at least a decade ago, this was a well established concern among scientists working on
endocrine disrupting chemicals.vi,vii By 2001, Neils Skakebaek and colleagues, working at the
forefront of EU research into genital abnormalities in baby boys and low sperm counts, highlighted
the concerns about phthalates.viii The anti-androgenic activity of the phthalates is now well
established, as is their potential to act in an additive manner, both with other phthalates or with
other anti-androgenic substances.ix,x However, apart from EU legal action to restrict the use of some
phthalates in childrens’ toys, phthalate usage has not been subject to stringent widespread
regulatory controls.
Unfortunately, a recent epidemiological study published by Swan and colleagues has now shown
that certain phthalates may indeed be having anti-androgenic effects in baby boys.xi Boys whose
mothers had the highest exposure to certain phthalates had reduced ano-genital distance, a measure
which is under the control of androgens. Another recent study has shown that phthalate levels in
breast milk are associated with a decrease in testosterone levels in baby boys. xii Unfortunately, this
case study shows that it could take literally years from getting the first indications of worrisome
properties in the laboratory, to getting scientific evidence of probable serious effects. This could
leave generations of children under threat.
However, it should be noted that some phthalates, including DEHP, DBP, and BBP have been
classified as category 2 reproductive toxicants, such that they could already be brought under
authorisation as fulfilling the R category. Nevertheless, other phthalates – such as di-isononyl
phthalate (DINP) – have not been classified as such, although this substance is reported to have
anti-androgenic properties, and moreover the levels of its metabolite (MINP) in breast milk has
been correlated with increased LH (Luteinizing Hormone) levels in baby boys. 12
Deca-brominated diphenyl ether (Deca-BDE) (Deca) case study
Another chemical, called deca-brominated diphenyl ether might also not be able to be subjected to
prior authorisation if the Council Common Position is adopted. This chemical is already generating
a lot of concern, but unlike phthalates and bisphenol A, it does not yet have known endocrine
disrupting properties.
Scientific evidence of effects in humans is lacking, and although one study in mice suggests it
interferes with brain function,xiii the implications of this are disputed by others, including the
company producing deca-BDE. Nevertheless, another study suggests that the other PBDE
chemicals have PCB-like effects in animals,xiv and it is now widely accepted that certain PCBs have
already affected childrens’ brain development at background levels, which have been found in
European countries.xv Moreover, thyroid disrupting chemicals, like PCBs, have been shown to act
additively or even synergistically.xvi
Decabromodiphenyl ether also continues to be a potential, though not absolutely proven,
environmental source of lower PBDE congeners that are considered to be PB(T) substances.
Several laboratory studies show that under certain conditions deca does degrade and lower PBDE
congeners are formedxvii,xviii,xix, but actually showing this occurs in nature is difficult.
In the absence of a new legal framework enabling and embracing precautionary action, the public
will be left to face ongoing contamination with a chemical, which is suggested to affect brain
development. At present, the ability to take precautionary action is embedded in EU constitution,
but it can be difficult to justify. For example, at an EU meeting on deca-BDE in 2004, the UK said
that it had a legal opinion which suggested that with the then current level of evidence it would not
be legally defensible to implement stricter controls on the basis of invoking the precautionary
principle. The UK CA sent a letter to the meeting stating that “At this stage, given the lack of
identifiable hazard – or risk, we believe the Precautionary Principle as defined in Communication
COM 2000 (2.2.2000) cannot be used in putting forward risk management measures.”xx
WWF believes that a robust framework to implement precaution is needed, and this could be
achieved by enabling such chemicals to be brought under prior authorisation procedure if they give
rise to a similar level of concern.
i
Brian JV, Harris CA, Scholze M, Backhaus T, Booy P, Lamoree M, Pojana G, Jonkers N, Runnalls T, Bonfa A, Marcomini A, Sumpter JP. 2005
Accurate prediction of the response of freshwater fish to a mixture of estrogenic chemicals. Environ Health Perspect. Jun;113(6):721-8.
ii
Vom Saal FS, Hughes C. An extensive new literature concerning low-dose effects of bisphenol a shows the need for a new risk assessment.Environ
Health Perspect. 2005 Aug;113(8):926-3
also www.ourstolenfuture.org/newscience/oncompounds/bisphenolA/2005/2005-0921alonso-magdalenaetal.htm
iii
Munoz-de-Toro M, Markey C, Wadia PR, Luque EH, Rubin BS, Sonnenschein C, Soto AM. 2005. Perinatal exposure to Bisphenol A alters
peripubertal mammary gland development in mice. Endocrinology. Epub ahead of print, May 26
iv
Sugiura-Ogasawara M, Ozaki Y, Sonta S, Makino T, Suzumori K. 2005. Exposure to bisphenol A is associated with recurrent miscarriage.Hum
Reprod. 2005 Aug;20(8):2325-9. Epub Jun 9.
v
Takeuchi T, Tsutsumi O, Ikezuki Y, Takai Y, Taketani Y.2004. Positive relationship between androgen and the endocrine disruptor, bisphenol A, in
normal women and women with ovarian dysfunction.Endocr J. Apr;51(2):165-9.
vi
Gray LE Jr, Ostby J, Sigmon R, Ferrell J, Rehnberg G, Linder R, Cooper R, Goldman J, Laskey J. 1988. The development of a protocol to assess
reproductive effects of toxicants in the rat. Reprod Toxicol. 2(3-4):281-7.
vii
Sharpe RM, Fisher JS, Millar MM, Jobling S, Sumpter JP. 1995. Gestational and lactational exposure of rats to xenoestrogens results in reduced
testicular size and sperm production. Environ Health Perspect. Dec;103(12):1136-43.
viii
Skakkebaek NE et al. (2001). Testicular dysgenesis syndrome: an increasingly common developmental disorder with environmental aspects.
Human Reproduction, Volume 16 (5): 972-978
ix
Foster, P. M., Turner, K. J., Barlow, N. J. (2000) Antiandrogenic effects of a phthalate combination on in utero male reproductive development in
the Sprague-Dawley rat: additivity of response? Toxicologist 66(1-S), 233.
x
Gray, L.E., Ostby, J., Wilson, V., Lambright, C., Bobseine, K., Hartig, P., Hotchkiss, A., Wolf, C., Furr, J., Price, M., Parks, L., Cooper, R.L.,
Stoker, T.E., Laws, S.C., Degitz, S.J., Jensen, K.M., Kahl, M.D., Korte, J.J., Makynen, E.A., Tietge, J.E., Ankley, G.T. (2002) Xenoendocrine
disrupters-tiered screening and testing. Filling key data gaps, Toxicology 181-182, 371-382.
xi
Swan SH et al. (2005) Decrease in Anogenital Distance among Male Infants with Prenatal Phthalate Exposure. Environ Health Perspect.
Aug;113(8):1056-61.
xii
Main, K.M., Mortensen, G.K., Kaleva, M.M., Boisen, K.A., Damgaard, I.N., Chellakooty, M., Schmidt, I.M., Suomi, A.M., Virtanen, H.E.,
Petersen, D.V., Andersson, A.M., Toppari, J., Skakkebaek, N.E.(2006) Human Breast Milk Contamination with Phthalates and Alterations of
Endogenous Reproductive Hormones in Infants Three Months of Age, Environ Health Perspect 114(2), 270-276.
xiii
Viberg H, Fredriksson A, Jakobsson E, Orn U, Eriksson P. 2003. Neurobehavioral derangements in adult mice receiving decabrominated diphenyl
ether (PBDE 209) during a defined period of neonatal brain development. Toxicol Sci. Nov;76(1):112-20. Epub Aug 12.
xiv
Viberg H, Fredriksson A, Eriksson P. Investigations of strain and/or gender differences in developmental neurotoxic effects of polybrominated
diphenyl ethers in mice.Toxicol Sci. 2004 Oct;81(2):344-53. Epub 2004 Jul 7.
xv
Damstra T, Barlow S, Bergman A, Kavlock R, Van Der Kraak G. 2002. Global Assessment of the State-of-the Science of Endocrine Disruptors.
WHO/PCS/EDC/02.2. Geneva:World Health Organization, International Programme on Chemical Safety.
xvi
Crofton, K.M., Craft, E.S., Hedge, J.M., Gennings, C., Simmons, J.E., Carchman, R.A., Hans Carter, W., DeVito, M.J. (2005) Thyroid hormone
disrupting chemicals: Evidence for dose dependent additivity or synergism, Env Health Perspect 113(11) 1549-1554.
xvii
Gerecke A. C., Hartmann P. C., Heeb N. V., Kohler H-P. E., Giger W., Schmid P., Zennegg M. and Kohler M. (2005). Anaerobic degradation of
decabromodiphenyl ether. Environ. Sci. Technol., 39, 1078-1083.
xviii
Keum Y-S. and Li Q. X. (2005). Reductive debromination of polybrominated diphenyl ethers by zerovalent iron. Environ. Sci. Technol., 39, 22802286.
xix
Eriksson J., Green N, Marsh G. and Bergman A. (2004a). Photochemical decomposition of 15 polybrominated diphenyl ether congeners in
methanol/water. Environ. Sci. Technol., 38, 3119-3125.
xx
DEFRA (2004). Letter to the EU Competent Authorities on chemical management meeting in Dublin, 21 May 2004, JM/24/2004, signed by
Elizabeth Surkovic, On behalf of the UK Competent Authority