Annex 1: Findings from ECJ case law
This Annex presents brief synopses of some of the key legal points to be found in the case law of the
European Court of Justice and its Court of First Instance / General Court with respect to the
precautionary principle and its application. The legal points are organised using the steps for applying
the PP in the chemicals regulatory field, as set forth in section 5 of these guidelines.
a. Has a potential negative effect been identified?
First, identification of the potentially negative consequences. In general, it is argued in case law that
a correct application of the precautionary principle presupposes, first, identification of the potentially
negative consequences for health of the proposed use of the substance at issue, and, secondly, a
comprehensive assessment of the risk to health based on the most reliable scientific data available and
the most recent results of international research. Gowan case (C-77/09); Commission v. France (C333/08)
Generalised presumption of a health risk not sufficient to justify Member States PP measure: A
Member State which establishes a prior authorisation scheme must justify the scheme by
demonstrating the existence of a genuine health risk. To require in national legislation establishing a
prior authorisation scheme that a mutual recognition clause be included would go against the very
rationale of such a scheme, since the Member State would be obliged to allow the marketing on its
territory of processing aids and foodstuffs benefiting from that clause without being able to verify the
absence of genuine risks for public health. Even if, as France claims, in accordance with the PP the
Member States merely has to establish the risk which the use of processing aids may pose, the fact
remains that the generalised presumption of a health risk is not supported by evidence to explain why
the marketing of any foodstuff, in the preparation of which processing aids have been used which have
been lawfully manufactured and/or marketed in other Member States, must depend on the entry of the
processing aid in question on a positive list established by France, which in turn depends on the
conformity of the foodstuff in question with purity criteria, requirements concerning maximum
residual doses or conditions for using processing aids laid down by that legislation. Comm. v France
(C-333/08)
The risks may not be purely hypothetical: In the domain of additives for feedingstuffs, the existence
of solid evidence which, while not resolving the scientific uncertainty, may reasonably raise doubts as
to the safety of a substance, justifies the withdrawal of the authorisation for that substance. The
precautionary principle is designed to prevent potential risks. By contrast, purely hypothetical risks ─
based on mere hypotheses that have not been scientifically confirmed ─ cannot be accepted (para 129,
referring to Pfizer Animal Health T-13/99). To make the maintenance of the authorisation of a
substance subject to proof of the lack of any risk, even a purely hypothetical one, would be both
unrealistic ─ in so far as such proof is generally impossible to give in scientific terms since zero risk
does not exist in practice and contrary to the principle of proportionality. Solvay Pharmaceuticals v.
Council (T-392/02)
The same conclusion, that purely hypothetical risks, based on mere hypotheses that have not been
scientifically confirmed, cannot be accepted, was drawn in the Kingdom of Sweden v Commission of
the European Communities (T-229/04).
Antibiotics in animal feed were suspected of making bacteria resistant against these antibiotics, which
can make it harder to treat humans infected by such bacteria with these antibiotics. Authorisation was
withdrawn. Producer Pfizer pointed at scientific reports saying the risk was not acute. ECJ: Risks may
not be purely hypothetical but must be “adequately backed up with scientific data” (para 144). The
scientific assessment must be as thorough as possible (para 162). Pfizer Animal Health (T-13/99)
A high degree of scientific and practical uncertainty, which is inseparable from the concept of
precaution, influences the extent of the discretion of the Member State and thus has an impact on the
means of applying the proportionality principle. In such circumstances, it must be acknowledged that a
Member State may, under the precautionary principle, take protective measures without having to wait
for the reality and the seriousness of those risks to be fully demonstrated. However, the assessment of
the risk cannot be based on purely hypothetical considerations. Commission v. France (C-333/08)
Although, in the absence of a proven risk to human health, such limits have not been established, a
scientific risk assessment could reveal that scientific uncertainty persists as regards the existence or
extent of real risks to human health. In such circumstances, it must be accepted that a Member State
may, in accordance with the precautionary principle, take protective measures without having to wait
until the reality and seriousness of those risks are fully demonstrated. However, the risk assessment
cannot be based on purely hypothetical considerations. In assessing the risk in question, it could be
appropriate to take into consideration not only the particular effects of the marketing of an individual
product containing a definite quantity of nutrients which are relevant but the cumulative effect of the
presence on the market of several sources, natural or artificial, of a particular nutrient and of the
possible existence in the future of additional sources which can reasonably be foreseen. Solgar
Vitamin's France and Others v Ministre de l'Économie, des Finances et de l'Emploi and Others (C446/08)
Threshold of proof as regards significant adverse environmental effects: In cases where the
Commission intends to show that obligations under the Urban waste water directive 91/271 were not
met (and thus an infringement of the directive exists) because a Member State did not identify
specified areas as sensitive areas with respect to eutrophication (bodies of waters which ‘in the near
future may become eutrophic’), the Commission has to present “at least a certain amount of evidence”
of fulfilment of the applicable eutrophication criteria, in particular as regards the significant adverse
environmental effects, and of the existence of the relationships of cause and effect. Comm. v UK &
Ireland (C-390/07)
b. Has a scientific evaluation of the substance been carried out?
Guidance in relation to the scientific evaluation that can be derived from case law includes the
following:
Examination of all relevant facts required: Scientific assessments finding risks acceptable are not
binding on the Commission, but all relevant facts must be examined carefully and impartially and
support the conclusions reached. Gowan (C-77/09)
Risk assessment involves determining what level of risk is deemed unacceptable and conducting a
scientific assessment of the risks. Risk assessment includes for the competent public authority, a twofold task, whose components are complementary and may overlap but, by reason of their different
roles, must not be confused. Risk assessment involves, first, determining what level of risk is deemed
unacceptable and, second, conducting a scientific assessment of the risks. As regards the first
component, it is appropriate to observe that it is for the Community institutions to define, observing
the applicable rules of the international and Community legal orders, the political objectives which
they intend to pursue within the parameters of the powers conferred on them by the Treaty. Thus
within the WTO and, more specifically, in the SPS Agreement, it is specifically provided that
members of that organisation may determine the level of protection which they deem appropriate. In
that regard, it is for the Community institutions to determine the level of protection which they deem
appropriate for society. It is by reference to that level of protection that they must then, while dealing
with the first component of the risk assessment, determine the level of risk - i.e. the critical probability
threshold for adverse effects on human health and for the seriousness of those possible effects - which
in their judgment is no longer acceptable for society and above which it is necessary, in the interests of
protecting human health, to take preventive measures in spite of any existing scientific uncertainty.
Therefore, determining the level of risk deemed unacceptable involves the Community institutions in
defining the political objectives to be pursued under the powers conferred on them by the Treaty.
As regards the second component of risk assessment, the Court already had occasion to note that in
matters relating to additives in feedingstuffs the Community institutions are responsible for carrying
out complex technical and scientific assessments. In such circumstances a scientific risk assessment
must be carried out before any preventive measures are taken. A scientific risk assessment is
commonly defined, at both international and Community level, as a scientific process consisting in the
identification and characterisation of a hazard, the assessment of exposure to the hazard and the
characterisation of the risk.
In that regard, first, when a scientific process is at issue, the competent public authority must, in
compliance with the relevant provisions, entrust a scientific risk assessment to experts who, once the
scientific process is completed, will provide it with scientific advice. The duty imposed on the
Community institutions by the first subparagraph of Article 129(1) of the Treaty to ensure a high level
of human health protection means that they must ensure that their decisions are taken in the light of the
best scientific information available and that they are based on the most recent results of international
research, as the Commission has itself emphasised in the Communication on Consumer Health and
Food Safety. Thus, in order to fulfil its function, scientific advice on matters relating to consumer
health must be based on the principles of excellence, independence and transparency. Second, it is
common ground between the parties that, when the precautionary principle is applied, it may prove
impossible to carry out a full risk assessment, because of the inadequate nature of the available
scientific data. A full risk assessment may require long and detailed scientific research. However,
unless the precautionary principle is to be rendered nugatory, the fact that it is impossible to carry out
a full scientific risk assessment does not prevent the competent public authority from taking preventive
measures, at very short notice if necessary, when such measures appear essential given the level of risk
to human health which the authority has deemed unacceptable for society.
In such a situation, the competent public authority must therefore weigh up its obligations and decide
either to wait until the results of more detailed scientific research become available or to act on the
basis of the scientific information available. Where measures for the protection of human health are
concerned, the outcome of that balancing exercise will depend, account being taken of the particular
circumstances of each individual case, on the level of risk which the authority deems unacceptable for
society. Pfizer Animal Health (T-13/99)
The generalised presumption of a health risk should be supported by evidence to explain measures
taken. In this case there is no demonstration that the conditions mentioned for the precautionary
principle to be applicable have been fulfilled. Even if the Member State merely has to establish the
risk which the use of processing aids may pose, the fact remains that the generalised presumption of a
health risk put forward by that Member State in this case is not supported by evidence to explain why
the marketing of any foodstuff, in the preparation of which processing aids have been used which have
been lawfully manufactured and/or marketed in other Member States, must depend on the entry of the
processing aid in question on a positive list established by French legislation, which in turn depends
on the conformity of the foodstuff in question with purity criteria, requirements concerning maximum
residual doses or conditions for using processing aids laid down by that legislation. Moreover, as
regards the evidence put forward by the French Republic to demonstrate that the choice of schemes at
issue is based on a comprehensive risk analysis in accordance with Articles 28 EC and 30 EC, it
should be noted that an Agence Française de Sécurité Sanitaire des Aliments (AFSSA, French Agency
for Food Safety) note from 2008 and its study report from 2007 to demonstrate that the legislation in
question complied with Articles 28 EC and 30 EC substantially post-date the 1912 Decree.
Furthermore, following the publication, on 2 December 2006, of the ministerial order referred to in
Article 2 of the 2001 Decree, the 1912 Decree was no longer in force at the time those documents
were drawn up. Commission v. France (C-333/08)
Account should be taken of the actual risk to public health. The criterion used by the Spanish
authorities for requiring marketing authorisation, namely the fact that the medicinal herb on which the
manufactured product is based is not listed in the Annex to the 1973 Order, does not allow, on the
basis of the most recent scientific data, account to be taken of the actual risk to public health presented
by such products and as such does not meet the requirements of Community law. Commission v. Spain
(C-88/07)
Origin of studies and assessments. In this case, it was clear from scientific documents and from the
debate between the parties that, when Directive 2009/30 was adopted, no public body or independent
entity had undertaken a scientific assessment of the effects of MMT on health. As regards the studies
provided by professionals in the sector, it was clear that the widely disparate conclusions reached on
that subject are dependent on whether the study relied on was carried out by the motor car industry or
by the producers of MMT. Afton Chemical (C-343/09)
Establishment beyond reasonable doubt. In order to determine whether the requirements laid down in
Article 5(1) of Directive 91/414 have been fulfilled in regard to human health, that provision refers
back to Article 4(1)(b)(iv) of the directive which provides, in essence, that it must be established that a
plant protection product has no harmful effect on human health, directly or indirectly, or on
groundwater. The effect of Article 5(4) of Directive 91/414 is to permit inclusion of active substances
which do not fulfil the requirements of Article 5(1) of the directive subject to certain restrictions which
exclude problematic uses of the substance involved. Since that provision is to be regarded as a
limitation on Article 5(1) of Directive 91/414, it must be interpreted in the light of the precautionary
principle. Consequently, before including a substance in Annex I to that directive, it must be
established beyond a reasonable doubt that the restrictions on the use of the substance involved make
it possible to ensure that use of that substance will be in accordance with the requirements laid down
in Article 5(1) of Directive 91/414. In this case, it was submitted that the AOEL is exceeded and that
there is not sufficient evidence in the dossier to justify inclusion of paraquat in Annex I to Directive
91/414. The Scientific Committee indicated in its opinion that field studies in various countries
showed that the mathematical models had very seriously overestimated real exposure in a work
situation. Consequently, it must be considered that in the circumstances of the present case, the
mathematical models do not, in themselves, constitute solid evidence which may reasonably raise
doubts as to the safety of paraquat. However, with regard to the field studies, in the Guatemalan study
it was found that one of the operators taking part in the study suffered exposure to paraquat equal to
118% of the AOEL. Since the Guatemalan study appears to constitute solid evidence which may
reasonably raise doubts as to the safety of paraquat for operators applying it the requirement laid down
in point C 2.4.1.1 of Annex VI, which prohibits any exceeding of the AOEL, has not been fulfilled.
However the criteria in Annex VI must be applied when evaluating an active substance under Article
5(1)(b) of Directive 91/414. Consequently, the contested directive infringes the requirement, laid
down in Article 5(1)(b) of Directive 91/414, to protect human health. Kingdom of Sweden v
Commission of the European Communities (T-229/04)
c. What are the uncertainties concerning the nature or probability of the possible
harm?
At times, an evaluation and/or risk assessment cannot be completed due to uncertainties. The
Communication underlines that in such cases, “all effort should be made to evaluate the available
scientific information” and “[w]here possible, a report should be made which indicates the assessment
of the existing knowledge and the available information, providing the views of the scientists on the
reliability of the assessment as well as on the remaining uncertainties. If necessary, it should also
contain the identification of topics for further scientific research.” Also, it sets out (at p. 16) that a
scientific evaluation should, where possible, identify “at each stage the degree of scientific
uncertainty”.
As was argued in the Gowan case, it follows from the precautionary principle that, where there is
uncertainty as to the existence or extent of risks to the health of consumers, the institutions may take
protective measures without having to wait until the reality and the seriousness of those risks become
fully apparent. Gowan (C-77/09)
Moreover, it has been argued in the Solvay Pharmaceuticals v. Council case that it is settled case-law
that, in the field of public health, the precautionary principle implies that, where there is uncertainty as
to the existence or extent of risks to human health, the institutions may take precautionary measures
without having to wait until the reality and seriousness of those risks become fully apparent. Solvay
Pharmaceuticals v. Council (T-392/02)
Impossibility to determine the existence or extent of the risk, however PP is justified if there is
likelihood of real harm. Where it proves to be impossible to determine with certainty the existence or
extent of the alleged risk because of the insufficiency, inconclusiveness or imprecision of the results of
studies conducted, but the likelihood of real harm to public health persists should the risk materialise,
the precautionary principle justifies the adoption of restrictive measures, provided they are nondiscriminatory and objective. In the light of the evidence put forward by certain Member States during
the work of the Standing Committee on the Food Chain and Animal Health as well as by the
Commission which tends to demonstrate that there was still some scientific uncertainty regarding the
assessment of the effects on the endocrine system of substances such as fenarimol, the Commission
cannot be considered to have applied the precautionary principle in a manifestly erroneous manner in
attaching restrictions on use to the authorisation of that substance. Gowan (C-77/09)
Recourse to the precautionary principle does not necessarily imply urgency. The adoption of a
precautionary measure in order to prevent a risk which cannot be demonstrated in the state of scientific
knowledge at the date of that adoption, but which is supported by sufficiently serious evidence, may in
certain cases be deferred on the basis of the nature, the seriousness and the scope of that risk on the
basis of a balancing of the various interests involved. During that balancing exercise the competent
authority enjoys a wide discretion. Solvay Pharmaceuticals v. Council (T-392/02)
Even in case of uncertainty, concept of zero tolerance may through PP result in the total ban of an
additive. In the domain of additives in feedingstuffs, Directive 70/524 makes the grant or maintenance
of authorisation for a substance subject to proof that there are no risks to human health. In accordance
with the principle that the protection of human health must prevail, that directive does not provide for
the balancing of such risks against the economic benefits or the benefits in terms of animal welfare
arising from the use of the substance in question, without prejudice to the discretion reserved to the
institutions concerned in respect of the management of risk where there is scientific uncertainty. In the
domain of additives, the competent institutions legitimately adopted a policy of zero tolerance with
regard to the potential risks to human health posed by the substances in question. That concept of zero
tolerance does not refer to purely hypothetical risks and cannot therefore be compared to the concept
of zero risk referred to above. In the present case, it may be found that if the concept of zero tolerance
may result, through the application of the precautionary principle, in the total ban of an additive even
in the case of uncertainty as to the extent of the potential risk in question, the existence of that
potential risk must nevertheless be supported by scientific data. Solvay Pharmaceuticals v. Council
(T-392/02)
Scientific uncertainty as to the existence or extent of risks to human health, protective measures
may be taken without having to wait until the reality and seriousness of those risks become fully
apparent. Where there is scientific uncertainty as to the existence or extent of risks to human health,
the Community institutions may, by reason of the precautionary principle, take protective measures
without having to wait until the reality and seriousness of those risks become fully apparent. The
Community institutions are not required, for the purpose of taking preventive action, to wait for the
adverse effects of the use of the product as a growth promoter to materialise. Thus, in a situation in
which the precautionary principle is applied, which by definition coincides with a situation in which
there is scientific uncertainty, a risk assessment cannot be required to provide the Community
institutions with conclusive scientific evidence of the reality of the risk and the seriousness of the
potential adverse effects were that risk to become a reality. However, a preventive measure cannot
properly be based on a purely hypothetical approach to the risk, founded on mere conjecture which has
not been scientifically verified (see Section a above). Rather, it follows from the Courts' interpretation
of the precautionary principle that a preventive measure may be taken only if the risk, although the
reality and extent thereof have not been `fully' demonstrated by conclusive scientific evidence, appears
nevertheless to be adequately backed up by the scientific data available at the time when the measure
was taken. The taking of measures, even preventive ones, on the basis of a purely hypothetical risk is
particularly inappropriate in a matter such as the one at issue here. The parties do not dispute that in
such matters a `zero risk' does not exist, since it is not possible to prove scientifically that there is no
current or future risk associated with the addition of antibiotics to feedingstuffs. Moreover, that
approach is even less appropriate in a situation in which the legislation already makes provision, as
one of the possible ways of giving effect to the precautionary principle, for a procedure for prior
authorisation of the products concerned. The precautionary principle can therefore apply only in
situations in which there is a risk, notably to human health, which, although it is not founded on mere
hypotheses that have not been scientifically confirmed, has not yet been fully demonstrated. Pfizer
Animal Health (T-13/99)
Likelihood. he United Kingdom maintained that the Commission placed excessive reliance upon
presumptions and upon the precautionary principle, in an attempt to make up for its inability to show
that certain eutrophication criteria were met or that a causal link between them was present. In
particular, the Commission was stated to posit an excessively low threshold of proof as regards waters
‘which in the near future may become eutrophic’ within the meaning of Annex II.A(a) of Directive
91/271. In order for the existence of such a situation to be found, proof is required that the bodies of
water concerned are likely to meet the four eutrophication criteria and to display the requisite
relationships of cause and effect between those criteria. In the present case, however, the Commission
relied on a presumption that, if some symptoms are present, then there is already a likelihood that an
area will become eutrophic. Consequently, in the present case, even though the Member States were
required to gather the data needed in order to determine the bodies of water that had to be identified as
sensitive to eutrophication under Article 5(1) of Directive 91/271, the Commission has the task of
adducing in support of the present action for failure to fulfil obligations at least a certain amount of
evidence, in respect of each of the areas at issue, first, of fulfilment of the four eutrophication criteria,
in particular as regards the significant adverse environmental effects covered by the last two criteria,
and second, of the existence of the relationships of cause and effect. Commission v. UK (Case C390/07)
Uncertainly requires non-discrimination and objectivity. Where it proves to be impossible to
determine with certainty the existence or extent of the alleged risk because of the insufficiency,
inconclusiveness or imprecision of the results of studies conducted, but the likelihood of real harm to
public health persists should the risk materialise, the precautionary principle justifies the adoption of
restrictive measures, provided they are non-discriminatory and objective. Commission v. France (C333/08)
Uncertainty on substance influences the required information. Since the nature of the harm which
might be caused by MMT is uncertain, there cannot be more precise information which makes it
possible to define the level of the MMT fuel content limit which would be capable of ensuring that
that harm was adequately prevented. Afton Chemical (C-343/09)
Provide probability on the basis of specific and coherent evidence .In order for a body of water to be
identified as a sensitive area with respect to eutrophication for the purposes of Directive 91/271, the
Commission is not required to produce evidence showing that all the hydrochemical parameters which
may cause such eutrophication are present or to provide irrefutable evidence that each of the
eutrophication criteria is fulfilled. However, the Commission cannot avoid proving, on the basis of
specific and coherent evidence, it is probable that, in the body of water, such accelerated growth
caused by nutrient enrichment will, in the near future, produce undesirable disturbance to the balance
of organisms present in the water and to the quality of the water. Proof of such probable adverse
effects on the environment is therefore in any event required Commission v. UK (Case C-390/07)
d. What are the options available for controlling the risk of possible harm
After carrying out a scientific evaluation / risk assessment as far as possible in which potential risks
are set out and uncertainties are indentified, the issue of adopting risk management measures comes
up. Different options are to be considered, according to the Communication, including the option of
taking no action, or – at the other end – introducing restrictions. Several cases dealt with the question
at which moment in time precautionary measures can be introduced. From these cases it followed that
the authorities do not need to wait until the reality and seriousness of the risks to human health are
fully demonstrated. Guidance can be found in the following case law includes:
Not necessary to wait until the reality and seriousness of the risks to human health are fully
demonstrated. When it is impossible to calculate precisely the intake of a mineral from other dietary
sources, a MS may set the maximum amount at a zero level. No purely hypothetical considerations,
but if a scientific risk assessment reveals that scientific uncertainty persists as regards the existence or
extent of risks to human health, a Member State may, in accordance with the PP, take protective
measures without having to wait until the reality and seriousness of those risks are fully demonstrated.
Solgar Vitamins (C-446/08)
Withdrawal from the market in accordance with the PP requires a showing of necessity as well as of
proportionality. Spain claims that in the current state of scientific research, there is uncertainty as
regards the harmlessness of the [medicinal herb] products withdrawn from the market that justifies
their withdrawal under the precautionary principle. The ECJ disagrees with this reasoning: the
requirement is that there be a detailed assessment, on a case by case basis, of the risk to public health
which the marketing of a product based on medicinal herbs might entail. Comm. v Spain (C-88/07)
Classification of a substance on basis of opinion of expert group and tests not PP and does not
manifestly exceed the limits of the Commission’s discretion. The Commission classifies a substance,
following the opinion of an expert group, which is based on the results of a number of tests carried out
using different methods, confirmed by information taken from specialist publications, or where it
classifies the same substance following the opinion of experts, itself based on the criteria set out in
point 4.2.3 of Annex VI to Directive 67/548 and, in particular, in point 4.2.3.3 of that annex, the
Commission’s exercise of its discretion is not vitiated by manifest error or by an abuse of power and
does not manifestly exceed the limits of its discretion. The Commission did not base its decision on
the PP, but on analyses carried out in accordance with the methods and the criteria laid down in
Annexes V and VI to Directive 67/548. EnviroTech (C-425/08)
In the Solvay Pharmaceuticals v. Council case, the Commission did not exceed the limits of its
discretion in finding that it sufficed that the risks considered were proven in respect of two substances
of the nitrofurans group, for it to suspect other substances in that group of posing the same risks and to
decide, in the present case, to carry out a re-evaluation of Nifursol in order to be satisfied that those
risks could be discounted in respect of that substance on the basis of the scientific evidence peculiar to
it. In the absence of proof, it cannot be found that the Council and the Commission committed a
manifest error of assessment in finding that the abovementioned doubts could be considered to be
sufficiently serious to justify the withdrawal of the authorisation of the substance in question pursuant
to the precautionary principle. It was found that, in adopting the contested regulation, the Council did
not commit any manifest error of assessment in finding that the safety of Nifursol was not sufficiently
certain, in the light of SCAN's very clear conclusions that, because of the need for further
mutagenicity and genotoxicity studies and the lack of data on developmental toxicity (teratogenicity),
it was not possible to fix an ADI. Solvay Pharmaceuticals v. Council (T-392/02)
Non-approval of active substance justified if conclusive risk assessment not possible: According to
EFSA the risk assessment was inconclusive because of the gaps in the data submitted by the applicant,
which made it impossible to set a threshold value. Notably:
–
no definitive reference value has been confirmed;
–
–
–
as definitive reference values were not agreed on, the risk assessment to operators, workers
and bystanders is inconclusive;
it is not possible to define a technical specification for dichlorvos;
no analytical methods for ascertaining the residues of dichlorvos in soil, water, air, blood and
animal tissues are available.
In view of the PP, the Commission, in light of available toxicological data, uncertainties of the
genotoxic and carcinogenic properties and gaps in the dossier which make it impossible to carry out a
conclusive risk assessment, did not make a manifest error of assessment in adopting the contested
decision or infringe Article 5 of Directive 91/414. Denka v Comm. (T-334/07)
e. Do the options for risk management meet the five elements of PP?
A scientific risk assessment must enable a decision that is appropriate and necessary. A scientific
risk assessment must also enable the competent authority to decide, in relation to risk management,
which measures appear to it to be appropriate and necessary to prevent the risk from materialising.
Pfizer Animal Health (T-13/99)
Non-discriminatory and objectivity required is risk cannot not established with certainty. Where it
proves to be impossible to determine with certainty the existence or extent of the alleged risk because
of the insufficiency, inconclusiveness or imprecision of the results of studies conducted, but the
likelihood of real harm to public health persists should the risk materialise, the precautionary principle
justifies the adoption of restrictive measures, provided that they are non-discriminatory and objective.
Solgar Vitamin's France and Others v Ministre de l'Économie, des Finances et de l'Emploi and Others
(C-446/08)
Lawfulness of a measure. Within the context of judicial review of the application of the principle of
proportionality, in view of the broad discretion which the Commission enjoys in adopting decisions
relating to the inclusion of active substances in Annex I to Directive 91/414, the lawfulness of a
measure can be affected only if the measure is manifestly inappropriate in relation to the objective
which it is intended to attain.
As regards the application of the principle of proportionality to the Commission’s decision not to take
into account data submitted after the procedural deadlines, it should be borne in mind that the
examination of the legislative framework together with the IQV judgment, carried out by the Court
reveals that, under the procedure leading to the adoption of a decision relating to the inclusion in
Annex I to Directive 91/414 of a substance covered by the procedure laid down in Article 8(2) of that
directive, a deferral must be granted if the notifiers of the active substance were in a situation of force
majeure which prevented them from complying with the procedural time-limits for the submission of
additional information to prove that there is a safe use for the active substance in question. However,
in this case the applicants have failed to prove that they were in a situation of force majeure which
prevented them from submitting, within the procedural time-limits, the data which the Commission
refused to take into account. In consequence, the Commission’s decision not to take into account the
data and studies at issue cannot be held to be in breach of the principle of proportionality.
Furthermore, in those circumstances, the decision not to include endosulfan in Annex I to Directive
91/414 is not disproportionate either, inasmuch as it is based on the absence of sufficient information
to show that there were no risks, such as those referred to in Article 5(1) of Directive 91/414, in view
of the fact that the objectives pursued by Directive 91/414 of protecting human and animal health and
the environment militate against a deferral of the decision to include or not to include the active
substance at issue in Annex I to Directive 91/414 being left to the discretion of the producers of the
active substance in question, and the fact that, in any event, it is possible for those producers to have
the active substance re-examined by means of the procedure provided for in Article 6(2) of Directive
91/414. Bayer Crop Science (T-75/06)
Compliance with principle of proportionality in exercise of discretion by Member States. A decision
to prohibit marketing, which indeed constitutes the most restrictive obstacle to trade in products
lawfully manufactured and marketed in other Member States, can be adopted only if the risk alleged
for public health appears sufficiently established on the basis of the latest scientific data available at
the date of the adoption of such decision. In such a context, the object of the risk assessment to be
carried out by the Member State is to appraise the degree of probability of harmful effects on human
health from the addition of certain nutrients to foodstuffs and the seriousness of those potential effects.
In exercising their discretion relating to the protection of public health, the Member States must
comply with the principle of proportionality. The means which they choose must therefore be confined
to what is actually necessary to ensure the safeguarding of public health; they must be proportional to
the objective thus pursued, which could not have been attained by measures which are less restrictive
of intra-Community trade. Commission v. France (C-333/08)
Disproportionate measures. Examination of the file concerning the prior authorisation scheme laid
down by the 1912 Decree shows that it is disproportionate in that it systematically prohibits, without
prior authorisation, the marketing of any processing aids or of any foodstuffs in the preparation of
which processing aids lawfully manufactured and/or marketed in other Member States were used,
without making any distinction according to the various processing aids or according to the level of
risk which their use might potentially pose for health. Commission v. France (C-333/08)
Proportionality check can be made for obligations in the light of the free movement of goods on the
internal market. The obligation to register reacted monomer substances which are components of
polymers does not go beyond that which is necessary to meet the objectives of the REACH
Regulation. Consequently, taking account of the limited number of potential monomer substances, the
12-year period of validity for a previous registration of substances, as provided for in Article 27 of the
REACH Regulation, and the possibility of sharing information in order to reduce costs, the burden
deriving from the obligation to register reacted monomer substances in polymers does not appear to be
manifestly disproportionate in the light of the free movement of goods on the internal market open to
fair competition. S.P.C.M. (C-558/07)
Principle of proportionality applies in exercising discretion relating to the protection of public
health. In exercising their discretion relating to the protection of public health, the Member States
must comply with the principle of proportionality. The means which they choose must therefore be
confined to what is actually necessary to ensure the safeguarding of public health or to meet overriding
requirements such as, for example the protection of consumers; they must be proportional to the
objective thus pursued, which could not have been attained by measures which are less restrictive of
intra-Community trade. Since Article 30 EC provides for an exception, to be interpreted strictly, to the
rule of free movement of goods within the Community, it is for the national authorities which invoke it
to show in each case, in the light of national nutritional habits and in the light of the results of
international scientific research, that their rules are necessary to give effective protection to the
interests referred to in that provision and, in particular, that the marketing of the products in question
poses a real risk to public health. The obligation to obtain marketing authorisation before being able to
market products based on medicinal herbs on Spanish territory may be regarded as in accordance with
the principle of proportionality only if it is actually necessary, in each case, to safeguard public health.
Such a restriction on the free movement of goods must therefore necessarily be based on a detailed
assessment, on a case-by-case basis, of the risk alleged by the Member State invoking Article 30 EC.
Commission v. Spain (C-88/07)
Need to seek for alternative solutions which are less harmful to public. National rules or practices
having, or likely to have, a restrictive effect on the importation of products are compatible with the
Treaty only to the extent that they are necessary for the effective protection of the health and life of
humans. A national rule or practice cannot therefore benefit from the derogation provided for in
Article 36 of the Treaty if the health and life of humans may be protected just as effectively by
measures which are less restrictive of intra-Community trade. The Swedish legislation prohibited the
use of trichloroethylene for industrial purposes and established a system of individual exemptions as it
submitted that trichloroethylene affects the central nervous system, the liver and kidneys. Taking
account of the latest medical research on the subject, and also the difficulty of establishing the
threshold above which exposure to trichloroethylene poses a serious health risk to humans, given the
present state of the research, there is no evidence in this case to justify a conclusion by the Court that
national legislation such as that at issue in the case in the main proceedings goes beyond what is
necessary to achieve the objective in view.
In particular, the system of individual exemptions, granted subject to conditions, established by the
Swedish regulation appears to be appropriate and proportionate in that it offers increased protection
for workers, whilst at the same time taking account of the undertakings' requirements in the matter of
continuity. First, exemption is granted on condition that no safer replacement product is available and
provided that the applicant continues to seek alternative solutions which are less harmful to public
health and the environment. Second, the concern to avoid causing disruption to an undertaking where
there is no alternative solution does not justify the grant of an exemption unless exposure to
trichloroethylene is at acceptable levels. Toolex (C-473/98)
Obligation to manufacturers to disclose formulas is not proportionate. One of the questions asked by
the referring national Court to the Court of Justice is whether Directive 2002/2/EC in so far as it
imposes an obligation to indicate the precise feed materials contained in compound feedingstuffs is
justified on the basis of the precautionary principle in the absence of a risk assessment based on
scientific studies examining the possible correlation between the quantity of feed materials used and
the risk of the diseases to be prevented. A further inquiry is whether the directive is justified in the
light of the principle of proportionality.Article 1(1)(b) of Directive 2002/2 on the circulation of
compound feedingstuffs is invalid in the light of the principle of proportionality. That obligation
impacts seriously on the economic interests of manufacturers, as it obliges them to disclose the
formulas for the composition of their products, at the risk of those products being used as models,
possibly by customers themselves, and those manufacturers cannot obtain the benefit of the
investments which they have made in terms of research and innovation. Such an obligation cannot be
justified by the pursued objective of protecting public health and manifestly goes beyond what is
necessary to attain that objective. Joined cases C-453/03, C-11/04, C-12/04 and C-194/04, ABNA A.B.
Measures are considered non-discriminatory in case they apply equally. The limit for the MMT
content of fuel is not discriminatory, since it applies to the whole of the European Union and to all
producers and importers of MMT. Moreover, the European Union legislature could justifiably take the
view that the appropriate manner of reconciling the high level of health and environmental protection
and the economic interests of producers of MMT was to limit the content of MMT in fuel on a
declining scale while providing for the possibility, in Article 8a(3) of Directive 98/70, of revising
those limits on the basis of the results of assessment. Afton Chemical (C-343/09)
Proportionality check in relation to the economic interests of producers. Having regard to the
uncertainty in relation to both the damage caused by the use of MMT and the risks created for users of
MMT, the setting of limits for the MMT content of fuel does not appear manifestly disproportionate in
relation to the economic interests of producers of MMT, in order to ensure a high level of protection of
health and the environment. Article 1(8) of Directive 2009/30 is, in so far as it inserts an Article 8a(2)
in Directive 98/70, not invalid by reason of the infringement of the precautionary principle and the
principle of proportionality. Afton Chemical (C-343/09)
f. Process for reaching decisions
The precautionary principle constitutes a general principle of EU law requiring the authorities in
question, in the particular context of the exercise of the powers conferred on them by the relevant
rules, to take appropriate measures to prevent specific potential risks to public health, safety and the
environment, by giving precedence to the requirements related to the protection of those interests over
economic interests. Solvay Pharmaceuticals v. Council (T-392/02)
Scope of the discretion of the institution. As regards the scope of the discretion of the relevant
institution it should be noted that, where scientific evaluation does not make it possible to determine
the existence of a risk with sufficient certainty, whether to have recourse to the precautionary principle
depends on the level of protection chosen by the competent authority in the exercise of its discretion,
taking account of the priorities that it defines in the light of the objectives it pursues in accordance
with the relevant rules of the Treaty and of secondary law. That choice must, however, comply with
the principle that the protection of public health, safety and the environment is to take precedence over
economic interests, as well as with the principles of proportionality and non-discrimination. When a
Community institution is called upon to make complex assessments, it enjoys a wide measure of
discretion the exercise of which is subject to a judicial review restricted to verifying that the measure
in question is not vitiated by a manifest error or a misuse of powers and that the competent authority
did not clearly exceed the bounds of its discretion. Under Article 3a of Directive 70/524, Community
authorisation of an additive is to be given if: ... (b) taking account of the conditions of use, it does not
adversely affect human or animal health or the environment, nor harm the consumer by impairing the
characteristics of animal products. Solvay Pharmaceuticals v. Council (T-392/02)
Identification of the potentially negative consequences and comprehensive assessment of the risk to
apply PP. A correct application of the precautionary principle presupposes, first, identification of the
potentially negative consequences for health of the proposed use of MMT, and, secondly, a
comprehensive assessment of the risk to health based on the most reliable scientific data available and
the most recent results of international research. Where it proves to be impossible to determine with
certainty the existence or extent of the alleged risk because of the insufficiency, inconclusiveness or
imprecision of the results of studies conducted, but the likelihood of real harm to public health persists
should the risk materialise, the precautionary principle justifies the adoption of restrictive measures,
provided they are non-discriminatory and objective. In those circumstances, it must be acknowledged
that the European Union legislature may, under the precautionary principle, take protective measures
without having to wait for the reality and the seriousness of those risks to be fully demonstrated. Afton
Chemical (C-343/09); Solgar Vitamin's France and Others v Ministre de l'Économie, des Finances et
de l'Emploi and Others (C-446/08)
Issues to be taken into account in assessment by authority. The level of risk deemed unacceptable
will depend on the assessment made by the competent public authority of the particular circumstances
of each individual case. In that regard, the authority may take account, inter alia, of the severity of the
impact on human health were the risk to occur, including the extent of possible adverse effects, the
persistency or reversibility of those effects and the possibility of delayed effects as well as of the more
or less concrete perception of the risk based on available scientific knowledge. Pfizer Animal Health
(T-13/99)
Reliable and cogent information must be provided to authority in order to understand assessment
made by experts. Where experts carry out a scientific risk assessment, the competent public authority
must be given sufficiently reliable and cogent information to allow it to understand the ramifications
of the scientific question raised and decide upon a policy in full knowledge of the facts. Consequently,
if it is not to adopt arbitrary measures, which cannot in any circumstances be rendered legitimate by
the precautionary principle, the competent public authority must ensure that any measures that it takes,
even preventive measures, are based on as thorough a scientific risk assessment as possible, account
being taken of the particular circumstances of the case at issue. Notwithstanding the existing scientific
uncertainty, the scientific risk assessment must enable the competent public authority to ascertain, on
the basis of the best available scientific data and the most recent results of international research,
whether matters have gone beyond the level of risk that it deems acceptable for society. Pfizer Animal
Health (T-13/99)
Need to ascertain degree of balance was attempted in legislation. It is necessary to ascertain whether,
in exercising its discretion, the European Union legislature attempted to achieve a degree of balance
between, on the one hand, the protection of health, environmental protection and consumer protection
and, on the other hand, the economic interests of traders, while pursuing the objective assigned to it by
the Treaty to ensure a high level of protection of health and environmental protection. Afton Chemical
(C-343/09)
Protection of public health takes precedence over economic considerations. Under the preautionary
principle prevailing in the matter of the protection of public health the competent authority may be
obliged to take appropriate measures to prevent certain potential risks for public health without having
to wait until the existence and seriousness of those risks has been fully demonstrated. If it was
necessary to wait until all the research was completed before adopting such measures the
precautionary principle would be rendered devoid of purpose. That reasoning also applies in the case
of a rapid information procedure such as the one introduced by directive 92/59/EEC. The applicant,
who is a victim of that alert system introduced in order to protect human health, must accept its
adverse economic consequences, since the protection of public health must take precedence over
economic considerations. It must be noted that it is not for the Commission to call in question, in the
context of the Community rapid alert system for food and feed, the findings and analyses that led the
national authorities to accept the existence of a serious and immediate risk requiring the triggering of
that system. Malagutti-Vezinhet SA v Commission of the European Communities ( T-177/02)
Non-approval of active substance justified where solid evidence exists that may reasonably raise
doubts: It follows from Dir. 91/414, interpreted in combination with the PP that, in the domain of
human health, the existence of solid evidence which, while not resolving scientific uncertainty, may
reasonably raise doubts as to the safety of a substance, justifies, in principle, the refusal to include that
substance in Annex I to the Directive. The PP is designed to prevent potential risks (Case T 229/04
Sweden v Commission [2007] ECR II 2437, paragraph 161). Cheminova (T-326/07)
Not necessary to wait until the existence and seriousness of the potential risks for public health fully
demonstrated. Under the PP prevailing in the matter of the protection of public health, the competent
authority may be obliged to take appropriate measures to prevent certain potential risks for public
health without having to wait until the existence and seriousness of those risks has been fully
demonstrated. If it was necessary to wait until all the research was completed before adopting such
measures the PP would be rendered devoid of purpose. That reasoning also applies in the case of a
rapid information procedure. The applicant, victim of that alert system introduced in order to protect
human health, must accept its adverse economic consequences, since the protection of public health
must take precedence over economic considerations. Malagutti-Vezinhet v Comm. (T-177/02); Gowan
case (C-77/09)
No express reference to precautionary principle required in contested regulation. A lack of express
reference to the precautionary principle in the contested regulation does not mean that that institution
did not rely on that principle, for the purposes of assessing the measures to be adopted under the
second indent of Article 9m of Directive 70/524 in order to prevent the alleged risks. On the contrary
that regulation expressly states that it is based on the fact that it was impossible in the case of Nifursol
to determine an ADI particularly given the lack of available scientific data in relation to
developmental toxicity. By thus finding that there was a potential risk, the contested regulation
implicitly but clearly applies the precautionary principle without prejudice to the limited review by the
courts of that application. Solvay Pharmaceuticals v. Council (T-392/02).
g. Is there a plan for reviewing the actions taken if new scientific knowledge?
‘Current scientific and technical knowledge’. The reference in Article 5(1) of Directive 91/414 to
‘current scientific and technical knowledge’ cannot support the inference that undertakings which have
notified an active substance and which are faced with the likelihood of a decision not to include that
substance in Annex I to Directive 91/414 should have the possibility of submitting new studies and
data for as long as doubts persist regarding the safety of that active substance. Such an interpretation
of that provision would run counter to the objective of a high level of protection of human and animal
health and of the environment which underlies Article 5(1) of Directive 91/414, in that it would be
tantamount to granting to the notifier – on whom the burden of proof lies as regards the safety of the
active substance and who has a better knowledge of that substance – a right of veto over the adoption
of a decision not to include the substance in Annex I to Directive 91/414. It must also be added that,
as regards the evaluation of malathion, the applicants do not allege nor, a fortiori, have they shown
that ‘current scientific and technical knowledge’ has developed since the notification of the dossier to
the RMS. The repeat of a test which has long been known about, namely the Ames test, cannot, in any
case, be assimilated to a change in ‘current scientific and technical knowledge’. Without showing a
new development in scientific knowledge concerning malathion since the notification of the dossier to
the RMS which could cast doubt on the reliability of the information contained in that dossier, the
applicants’ argument that the Commission was under an obligation to take account of ‘current
scientific and technical knowledge’ cannot, in any event, succeed. Cheminova and Others v. European
Commission (T-326/07)
Annex 2: The substance case studies
The selected case studies cover five substances selected for elaboration as practical examples on the
use of the precautionary principle in the field of human health and the environment: phthalates,
bisphenol A, fenamirol, nickel carbonate, and polymers containing reacted monomers. An additional
case study on nanosilver considers a substance where precautionary approaches have been
considered. The case studies provide some background on the substances and their risks, as well as
the ongoing debate towards how to apply the precautionary principle for (certain uses) of these
substances.
1.1 Phthalates
Phthalates have/had a wide range of uses, primarily as plastics additives to provide flexibility in
otherwise rigid plastics. They have been used in PVC baby soothers and in baby toys, and may leach
out of such products when babies put them in their mouth. Toxicology studies on the phthalates
have shown that they are reproductive toxicants, having an effect both on fertility and on
development of the embryo. A potential health risk to young children through use of these PVC
articles was therefore identified.
It turned out to be very difficult to establish the actual existence of such a risk with scientific
certainty, but nevertheless, the Commission, supported by the Member States, took action to
regulate the use of the phthalates in PVC articles intended for young children. Phthalates thus form
an example of the application of the precautionary principle. This case study focuses on the findings
of the Scientific Committee on Toxicity, Ecotoxicity and the Environment (SCTEE) and the actions
taken by the Commission on phthalates.
Following risk assessments carried out by individual Member States consequential to the emerging
concern regarding the toxicological hazards of the phthalates and exposure assessments for different
population groups including young children, in February 1998 the SCTEE published its preliminary
findings on the potential risks to infants from phthalates in baby toys. For certain phthalates, the
study showed that leaching could occur, resulting in exposures in young children “mouthing” these
toys in excess of levels considered by the SCTEE scientists to be safe to health. However, one of the
difficulties in the SCTEE exposure estimates was the lack of an acceptable scientific method for
testing the migration of phthalates from toys to the mouth.
In a reaction, a spokesperson for Toy Industries of Europe stressed that the industry was ready to act
if health risks were proved, while expressing scepticism over the test protocol used by the committee
to measure leaching. Moreover the industry was disappointed that action was already being
considered after a “very short” period of study. Spain and Denmark called for EC action, but
discussions between the Member States were not unanimous and the Commission did not
immediately initiate risk management measures.
At the end of April 1998, the Scientific Committee presented its final advice. The Committee
considered the results of tests in which the conditions undergone when PVC items are sucked or
chewed were reproduced and compared the levels of migration of phthalates into a model saliva
solution with the so-called ‘no observed adverse effect levels’ (NOAEL). For three out of the five
phthalates investigated - DIDP, DBP and BBP - migration levels were much lower than the margin of
safety defined by the committee of one-hundredth of the NOAEL. However, the migration of three
others - DINP, DNOP and DEHP - was found to have a very low margin of safety of only 2.7, 62 and 21
respectively. The migration of phthalates into babies’ saliva was described as a “cause for concern”.
On 16 June 1998, supplementary clarifications were issued by the SCTEE, addressing the question of
whether on the basis of the Scientific Opinion of 24 April 1998 it was possible to say that there
existed a serious and immediate risk. The SCTEE indicated that this was dependent upon the
definitions of the term ‘immediate’ and ‘serious’. In this clarification, the SCTEE did add that the risk
identified was not sufficient to fall within the ‘life-threatening’ category.
At the same time, the SCTEE underlined that a health concern might exist “if the phthalate
extractability is likely to exceed the proposed guideline values”. In other words, no real clarification
was offered and the responsibility for deciding whether or not action was justified was placed on the
Commission’s table. On 1 July 1998, the Commission issued Recommendation 98/485 1 on the
matter, claiming, on the one hand, that there was insufficient scientific justification for an EC-wide
ban but, on the other hand, advising the Member States to decide for themselves whether regulatory
measures against phthalates were necessary after assessing their health risks. The precautionary
principle was not specifically mentioned as a reason for such national measures in the face of absent
scientific certainty on their necessity. Still, the Commission did point out that the SCTEE had
recommended that certain limit values for the migration of phthalates should not be exceeded
(these values were reproduced in an annex to the Recommendation) and that “migration limit values
are liable to be exceeded in certain cases”.
All of this points in the direction of recommending that the Member States apply the precautionary
principle, even if no specific reference was made to the principle 2 . It would take a further 18 months
before the Commission did agree on a precautionary ban on children’s toys and childcare articles
containing certain phthalates throughout the EC. In the meantime, in November 1998, the SCTEE had
issued a new opinion on phthalates in toys, taking into account the results of the most recent
relevant studies. The SCTEE revised its opinion of 24 April 1998 with respect to the concern arising
from the exposure of children to two specific phthalates; both appeared to be more toxic than
previously thought.
Subsequently, Austria, Denmark, Greece, Finland, France, Italy and Sweden all notified the adoption
of health protection measures with regard to products for children containing certain phthalates. The
additional scientific research and the opinion of the SCTEE of November 1998 confirmed that there
were grounds of concern surrounding the low safety margins as regards the exposure of children to
two specific phthalates. Consequently, the Commission found that the time had come to adopt a
temporary ban throughout the Community.
1
Commission Recommendation 98/485 of 1 July 1998 on childcare articles and toys intended to be placed in the mouth by
children of less than three years of age, made of soft PVC containing certain phthalates, OJ 1998, L217/35
2
Around the same time, in the USA the Consumer Product Safety Commission had concluded from a detailed quantitative
risk assessment (estimating DINP exposure through adult volunteers) that no apparent significant risk existed. However,
due to lingering uncertainties industry was asked to voluntarily remove phthalates from toys. See J. Tickner and P. Hoppin,
‘Children’s environmental health: a case study in implementing the precautionary principle’, Int J Occup Environ Health, no.
3, 2000, p. 281-288.
On the basis of Article 9 of Directive 92/59 on general product safety, the Commission adopted a
precautionary decision that prohibited the placing on the market of toys and childcare articles
containing certain phthalates. The Commission concluded it appeared under certain conditions that
two specific phthalates may have serious adverse health effects and decided to ban their use. As for
other phthalates, the Commission noted that according to the SCTEE their release was low and
presented no risk under current conditions of use. However, the risk would be higher if these
substances were to be used as a replacement for the two other phthalates. Therefore, the
Commission, “adopting a precautionary approach, considers that this Decision should also apply to
them.”
The Commission added to these considerations that young children are also exposed to phthalates
from other sources, but that the level of these sources cannot be quantified because of a lack of
sufficient data. The existence of such additional exposure should however be taken into account in
managing the risks in question. It was admitted that the serious effects do not become manifest until
sometime after exposure. Still, the Commission explained, “the risk associated with the products in
question is an immediate one because it is directly associated with exposure to phthalates.” In this
way, the Commission argued that phthalates in children’s toys and childcare articles are liable to
present a serious and immediate risk to health - and that Article 9 of Directive 92/59 could be used as
a legal basis. In the preamble to the Decision, some additional arguments were put forward as to the
reasons why by December 1999, it was urgent to adopt a Community-wide ban, whereas in mid-1998
a recommendation was considered to be sufficient. In spite of these arguments it seems that the
Community could have opted for a temporary ban in 1998 rather than waiting for additional
information and Member States adopting their own precautionary measures.
Meanwhile, the Decision - valid for a period of three months due to the Directive on which it is based
- was extended on numerous occasions. A ‘regular’ ban on phthalates in children’s products has since
been adopted. 3 Softener industry trade body ECPI blasted this measure as an "entirely political
decision that misuses the precautionary principle" but Jim Murray of EU consumer body BEUC
praised the decision as ensuring the protection of the most vulnerable consumers. 4 The Directive
requires the commission to re-evaluate the measures in the light of any new scientific information by
16 January 2010.
Discussions on restricting the use of phthalates in other products like medical appliances and pet toys
continue. After having been identified as very high concern chemicals (SVHC) at an earlier stage, in
February 2011 it became clear that under REACH, three phthalates (DEHP, BBP and DBP) are to be
banned, unless certain uses are authorised, as from 21 February 2015. 5
Further support for a wider application of the precautionary principle in relation to use of phthalates
in any product that may come into contact with young children is evidenced by the findings of a
3
Directive 2005/84/EC of 14 December 2005bamending for the 22nd time Council Directive 76/769/EEC on the
approximation of the laws, regulations and administrative provisions of the Member States relating to
restrictions on the marketing and use of certain dangerous substances and preparations (phthalates in toys and
childcare articles).
4
ENDS Europe, 5 July 2005.
Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regulation (EC) No 1907/2006 of
the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of
Chemicals (‘REACH’).
5
recent study 6 carried out by BUND in Germany, showing that concentrations of phthalates in the
environment in kindergartens and nurseries were over three times higher than in private households.
The study found an average of 3368 mg phthalates per kg dust in kindergardens, compared with an
average of 1023 mg/kg in private households. The explanation for these findings is likely to be the
high proportion plastics used in kindergartens and nurseries for easier cleaning, better safety etc,
including plastic/PVC floors, wallpapers, tablecloths, etc. containing phthalates. As a consequence of
this study BUND is calling for further controls on phthalates.
1.2 Bisphenol A
The Commission’s 2000 Communication on application of the Precautionary Principle indicates that
this should be based on the outcome of a risk assessment, comprising the four phases of hazard
identification, hazard characterisation, exposure assessment and risk characterisation. If the
outcome of the risk assessment finds a characterisable risk based on “sound science” (a robust risk
assessment), there is the basis for risk management action, e.g. control of use/banning. The
application of the precautionary principle influences the balance between the robustness of the risk
assessment and the implementation of risk management.
The case of Bisphenol A is an interesting example of this process. Bisphenol A (BPA) is a chemical
produced in large quantities for use primarily in the production of polycarbonate plastics and epoxy
resins (Figure 1). Polycarbonate plastics have many applications including use in certain food and
drink packaging, e.g., water and infant bottles. BPA has received considerable attention in recent
years due to concern for the reproductive and developmental effects seen in laboratory animal
studies. There is extensive human exposure due to its widespread uses, and particular concern has
been expressed regarding the exposure (and consequent risk) for young children due to the use in
polycarbonate feeding bottles for infants.
The European Union in 2003 published a comprehensive Risk Assessment Report (RAR) for BPA under
the Existing Chemicals Regulation 793/93, in which one of the key conclusions on risks for consumers
and also risks for the environment and for humans exposed via the environment was that there was
a need for further information and/or testing in relation to developmental toxicity and effects on
endocrine disruption. Overall, in standard developmental studies in rodents, there was no convincing
evidence that bisphenol-A is a developmental toxicant. However, studies conducted using low doses
(in the μg/kg range) had shown variable and conflicting effects of BPA on endpoints relevant to
development and endocrine function and did cause concerns. Overall, the majority of EU risk
assessors involved in the discussion of the risk of BPA at that time felt that the studies reporting
effects at low doses could not be dismissed, and considered that further research was needed to
resolve the uncertainties surrounding the potential for bisphenol A to produce adverse effects on
development at low doses.
6
http://www.bund.net/fileadmin/bundnet/pdfs/chemie/20110321_chemie_weichmacher_kitas_hintergrund.pdf
While there was considerable debate regarding the need for risk management measures for BPA at
the time of the finalisation of the EU risk assessment, no precautionary measures were introduced at
that moment in time. It was merely acknowledged there were uncertainties regarding the effects,
and the need for further testing/research was identified. Since that time, however the debate has
continued in a number of arenas, within the EU and at the international level. In particular, the focus
of the debate has shifted to the uses of BPA that are of most concern, namely the use of BPA in
products which come into contact with food and are used by young children, in particular baby
bottles. The specific area of legislation covering such “food contact materials” falls into the food
safety area, under the responsibility of DG-SANCO, and the most recent risk assessments have been
carried out by the European Food Safety Authority (EFSA).
Previous risk assessments of BPA as a food contact material had been carried out by the Scientific
Committee for Food (SCF), the predecessor of EFSA. In 2002 the SCF derived a temporary Tolerable
Daily Intake (TDI) of 0.01 mg BPA/kg bw/day, based on an oral No-Observed-Adverse-Effect Level
(NOAEL) for BPA of 5 milligrams/kg bw/day taken from a 3-generation reproduction study in the rat
that used dose levels ranging down to 1 microgram/kg bw/day, and applying an uncertainty factor of
500. Due to the continued concern regarding the reported “low dose” effects of BPA and new
studies published in this area, the Commission requested EFSA to carry out a new risk assessment.
The outcome of this risk assessment was published in 2006, and the overall conclusion was that lowdose effects of BPA in rodents had not been demonstrated in a robust and reproducible way, and
thus they could not be used as pivotal studies for risk assessment. EFSA therefore supported the
SCF’s risk assessment, however they also took into account a newly-available two-generation
reproductive toxicity study of BPA in mice which had been undertaken in part in response to the
earlier-identified need for more research into the effects of BPA on development at low doses. This
study also identified a NOAEL of 5 milligrams/kg bw/day, and EFSA derived a new, higher, ADI of
0.01 mg BPA/kg bw/day. Thus, at this stage, the advice from the risk assessors was that BPA did not
represent a risk to consumers, including young children/babies, and that a TDI could be supported on
the basis of the scientific evidence. The Commission did not therefore consider that any risk
management measures were appropriate.
However, in the period between 2006 and 2010, public and regulatory concern regarding the safety
of BPA increased. In 2008, Health Canada carried out a risk assessment on BPA and concluded that
the general principle of ALARA (as low as reasonably achievable) should be applied to limit BPA
exposure from food packaging applications of newborns and infants, based on the results of
neurodevelopmental and behavioural studies in experimental animals showing effects at low doses.
Health Canada however noted that there were uncertainties related to methodology used in these
studies, raising questions as to the actual significance these findings may have on the potential risk to
human health. Nevertheless, the Canadian government formally declared the chemical a hazardous
substance, placed BPA on its list of toxic substances, and its use in products designed for babies and
young children was prohibited. Also, in the US, the National Toxicology Programme expressed “some
concern” for effects on the brain, behaviour, and prostate gland in foetuses, infants, and children at
current human exposures to BPA, and the US FDA has been under some pressure to reconsider the
authorisation of BPA in food contact materials.
Similarly, in the EU, EFSA was again asked to consider any new data on BPA since the last evaluation
in 2006 and to update the existing TDI accordingly. EFSA published their opinion in late 2010, and
concluded that they could not identify any new evidence which would lead them to revise the
current TDI for BPA of 0.05 mg/kg body weight set by EFSA in its 2006 opinion. In addition, the Panel
also stated that the currently available data did not provide convincing evidence of neurobehavioural
toxicity of BPA. However, whilst maintaining the TDI for BPA, the Panel also noted that certain
uncertainties were identified in several new studies, but these studies were not considered suitable
for assessment of possible effects on human health because of methodological deficiencies.
Although EFSA had delivered a “positive” opinion, indicating that based on a consideration of all
available scientific evidence there was no need to withdraw or reduce the TDI , the Commission was
under pressure from a number of Member States to consider introduction of risk management
measures. Notably, Denmark had already introduced national measures to restrict the use of
Bisphenol A in materials in contact with food intended for children aged 0-3 years in July 2010, and a
number of other Member States including France had signalled their intention to introduce similar
measures. Thus in late 2010 the Commission tabled a proposal to amend Annex II of Directive
2002/72 to prohibit the use of BPA in materials and articles intended to come into contact with
infant formula and follow-on formula, despite the outcome of the scientific risk assessment.
Although opinion was divided among Member States on whether to support the possible restrictions
proposed by the Commission, in the light of the uncertainties identified in the EFSA opinion, along
with the introduction of national measures to restrict the use of BPA in certain European countries,
meaning controls were no longer harmonised, Member States voted on 25 November 2010 to
introduce Europe-wide controls on a precautionary basis to prohibit the manufacture and sale of
BPA-based infant feeding bottles. The ban on manufacture of the bottles within the EU came into
effect on 1 March 2011, with import and sales of the bottles prohibited from 1 June 2011.
In this case, the Commission implemented the precautionary principle despite the outcome of
several risk assessments of BPA. The Commission’s decision was in part based on the lack of
agreement on interpretation of the data, including the fact that a minority opinion had been
expressed within the EFSA opinion. The significant public pressure created by the concerns regarding
the safety of BPA, plus international developments, undoubtedly contributed to their decision.
1.3 Fenamirol
Fenarimol is a pyrimidine carbinol used as fungicide (e.g. against rusts, blackspot and real mildews on
ornamental plants and turf, but also for peppers, tomatoes and cucumbers). Concern with respect to
Fenamirol arises due to its intrinsic toxic effects, including potential endocrine disrupting properties;
it has been identified as a weak oestrogen receptor agonist.
The effects on human health and the environment from Fenarimol were assessed during its review
under Directive 91/414/EC with the United Kingdom designated as Rapporteur. The UK submitted
the relevant assessment report and recommendations to the Commission on 30 April 1996. The
overall conclusion from the evaluation was that plant protection products containing Fenarimol will
fulfil the safety requirements in Directive 91/414/EEC but that Member States must pay particular
attention to the protection of:
-
aquatic organisms;
earthworms;
birds and mammals;
operators and workers.
The Scientific Committee on Plants concluded that the effects of Fenarimol on male fertility seen in
rats were relevant for human risk assessment although man is less sensitive than rats. Though there
is no scientific consensus on the exact extent of the risk, a number of Member States raised
concerns.
The Commission, after extensive discussion with Member States, proposed to restrict the use of
Fenarimol; this was confirmed in Directive 2006/134/EC of 11 December 2006 amending Council
Directive 91/414/EEC to include Fenarimol as active substance (OJ 2006 L 349, p. 32) with
restrictions, in that only uses as fungicide on the following crops may be authorised:
-
tomatoes,
peppers in greenhouses,
eggplants (aubergines),
cucumbers in greenhouses,
melons,
ornamentals, nursery trees and perennial plants,
…
In addition, the following uses and methods of application must not be authorised:
-
air application,
knapsack and hand-held applications by amateur users,
home gardening.
Finally, Member States shall ensure that all appropriate risk mitigation measures are applied. Special
attention has to be paid to the following issues:
-
aquatic organisms …
earthworms …
birds and mammals …
operators …
workers …
In addition it was required that Member States shall request the submission of further studies to
address the potential endocrine disrupting properties of Fenarimol within two years after the
adoption of the Test Guidelines on endocrine disruption by the Organisation for Economic
Cooperation and Development (OECD).
In case C-77/09 (Gowan), the plaintiff argued that the severity of the restrictions on the use of
Fenarimol was not justified by the assessment carried out by the UK and that the reliance on the
precautionary principle as a justification for the restrictions imposed was also not justified.
The Court confirmed that the principle may be applied only in the case of scientific uncertainty,
resulting, inter alia, from data which are are inadequate, inconclusive, or imprecise. It decided that as
there was still some scientific uncertainty regarding the assessment of the effects on the endocrine
system of substances such as Fenarimol, the Commission could not be considered to have applied
the precautionary principle in a manifestly erroneous manner in attaching restrictions on use to the
authorisation of that substance.
1.4 Nickel carbonate
Nickel carbonates are used in electroplating, some ceramic applications (glaze and coloring agent)
and as precursors to catalysts. They were classified as Carcinogenic Category 1; R49 (Carc. Cat. 1), as
well as, for mutagenicity (Muta. Cat. 3) and reproductive toxicity (Repr. Cat. 2), plus additional
hazards, in Commission Directive 2008/58/EC (the ‘30th ATP Directive’) and Commission Regulation
(EC) No 790/2009 (the ‘1st ATP Regulation’). 7
Denmark was rapporteur under the Existing Substances Regulation (EEC) 793/93 for the risk
assessment of five high production volume nickel substances: nickel metal, nickel sulphate, nickel
dichloride, nickel dinitrate, and nickel carbonate. The hazard information, gathered as part of the risk
assessment, was discussed in the Technical Committee for Classification and Labelling from
November 2003 to September 2004 when agreement was reached on the harmonised classification
and labelling of the five substances.
At their meeting in April 2004, the Specialised Experts concluded that nickel sulphate and nickel
chloride should be considered as human carcinogens (Carc. Cat. 1). The classification of the nickel
salts were based on epidemiological results following inhalation exposure that demonstrated a
causal association between human exposure to the substances and the development of lung cancer.
There was also supporting evidence for their conclusion from more limited data on nasal cancer. A
variety of effects were also demonstrated in a large number of experimental studies with different
nickel species. Since a number of water soluble nickel compounds as well as the insoluble inorganic
nickel compounds are already classified in Annex I as human carcinogens, on the basis of validated
structure-activity relationships and expert judgment, the Specialised Experts advised that nickel
carbonate should also be considered as a human carcinogen.
The Member States gave a favourable opinion on the proposal by qualified majority in February 2007
and the 30th ATP Directive was adopted on 9 June 2008.
In case C-14/10 the ECJ was asked for its opinion with reference to the 30th ATP Directive and also to
Commission Regulation (EC) No 790/2009 8 related to the classification of Nickel Carbonates for
carcinogenicity. The plaintiffs questioned whether there was adequate assessment of the intrinsic
properties of the nickel carbonates in arriving at the classifications and expressed doubt as to
whether the intrinsic properties of the nickel carbonates presented a risk during normal handling and
use such as to warrant such a classification.
The Advocate General’s opinion released on 24 March 2011 confirmed that the Commission had a
broad discretion, in particular as to the assessment of highly complex scientific and technical facts, to
determine the measures that are necessary and appropriate for the protection of public health. In
terms of the classification of substances, this means the Commission has considerable discretion
concerning the extent of the measures to be taken in order to adapt the annexes to that directive to
technical progress. The Advocate General (AG) found it clear that section 1.6.1(b) of Directive 67/548
Annex VI allows the data required for classification to be obtained from a number of different
sources, including the results of validated structure-activity relationships and expert judgment. In
particular, the principles laid down in that section do not preclude the Commission from having
7
Under the CLP Regulation, Carc. Cat. IA, Muta. Cat. II, and Repr. Cat. IB.
Commission Regulation (EC) No 790/2009 added the nickel carbonates to the REACH Annex XVII list of
substances restricted for use in consumer products.
8
recourse to the read-across method for the purposes of its assessment. In addition, the use of the
read-across method is broadly accepted and widely publicised in the scientific community.
In relation to the issue of normal handling and use, the AG stated that classification is based on the
hazards associated with normal handling or use of a substance to make it possible for the same
information to be provided in an appropriate manner to all users of chemicals, irrespective of the
location and methods of use. That information thus enables the competent authorities to adopt
independent decisions on the risk management measures to be taken, which may vary considerably
depending on the conditions and types of use. Hazards must therefore be classified independently of
the manner or location in which the substance is used – whether in a laboratory or outside a
laboratory – independently of the means by which exposure occurs, whether orally, by dermal
exposure or by inhalation, and of the levels of exposure to the substance. Such classification must
not be limited by consideration of specific uses.
The AG opinion pointed out that one of the consequences of the classification of a substance as a
CMR cat 1 or 2 is that its use by consumers (as a substance or mixture) is normally restricted,
previously through Directive 76/769/EEC and subsequently by REACH. In the former case, the
substances classified in a specific ATP to Directive 67/548/EEC were added to the list of substances
listed in the appendix concerning points 29, 30 and 31 of Annex I to Directive 76/769/EEC. It was
normal practice that within six months of the classification being published, the Commission
proposed restrictions on their placing on the market and use by consumers as substances or in
mixtures (above specific concentration limits). The risks and advantages of the substances were
normally taken into account in proposing them for such a restriction (see recital 8 of Directive
2003/36/EC amending, for the 25th time, Council Directive 76/769/EEC). In REACH, Article 68(2)
allows that a substance meeting the criteria for classification as carcinogenic, mutagenic or toxic to
reproduction (CMR), category 1 or 2, and could be used by consumers can be proposed for
restriction by the Commission and do not have to go through the normal procedure for restrictions
under REACH (i.e. an opinion of the Risk Assessment and Socio-economic Assessment Committees).
This latter procedure does not preclude the commission also taking into account the risks and
advantages of the substances before making its proposal.
Although the AG opinion did not mention the precautionary principle specifically, the points
addressed are relevant for the first three stages of chemical regulatory decision-making leading up to
the classification of a substance, i.e. the stages before a risk management decisions are taken (see
section 3.1 below). As was noted before, at these stages the Communication stresses that the PP is
not yet decisive, but rather a prudent approach is to be applied. The ECJ judgment itself is expected
to be published later in 2011.
1.5 Registration of polymers containing reacted monomer substances
This case study provides an example of the application of the precautionary principle to the
notification of polymers and the monomers used in their manufacture, potentially present as
residues in the final polymer. In accordance with Article 2(9) of REACH, polymers are exempt from
registration, reflecting the often inert nature, stability and lack of intrinsic hazard of such materials,
although Recital 41 states that “polymers should be exempted from registration and evaluation until
those that need to be registered due to the risks posed to human health or the environment can be
selected in a practicable and cost-efficient way on the basis of sound technical and valid scientific
criteria.” 9 This was also the case under the previous European Union legislation (Directive 92/32/EC),
and extensive guidance was developed, providing a definition of “polymer” and technical criteria for
establishing whether a material could be considered to fall within this definition and under what
circumstances polymeric substances should be notified. REACH also provides a definition of
“polymer” “monomer” and “substance”, which are relevant in considering their registration status.
Although polymers are exempt from registration, the monomers used in their manufacture are not.
This reflects the need to have hazard information on such substances, since there is exposure of both
workers and the environment. There is also potential exposure to residual monomer in the polymer
after polymerisation, for consumers and others using/handling the polymer product. In the situation
where the polymer has been manufactured outside the European Union and the monomer per se is
not used in the European Union, under Article 6(3) of REACH the legal position regarding notification
is still clear, as follows:
6(3)
Any manufacturer or importer of a polymer shall submit a registration to the
Agency for the monomer substance(s) or any other substance(s) that have not already been
registered by an actor up the supply chain, if both the following conditions are met:
(a) the polymer consists of 2% weight by weight (w/w) or more of such monomer
substance(s) or other substance(s) in the form of monomeric units and chemically
bound substance(s);
(b) the total quantity of such monomer substance(s) or other substance(s) makes up 1
tonne or more per year.
Article 6(3)(a) specifically addresses the issue of monomer present as monomeric units in a polymer,
and the interpretation of this provision was challenged by a non-EU manufacturer of polymers and
the importer(s)/sole representative in the European Union, who argued that in their opinion,
polymers falling under Article 6(3) did not have to be notified. Basing their argumentation on two
expert opinions compiled by the Netherlands Organisation for Applied Scientific Research (TNO), the
applicants argued that “reacted monomers cease to exhibit their own individual chemical
characteristics and that polymers are generally stable and safe.” They argued that, if the words
‘monomer substances’ in Article 6(3) of the REACH Regulation were to mean or include reacted
monomers, it would make no sense to exempt polymers from registration while requiring the
registration of monomer substances. They also argued that such an interpretation would be
inconsistent with the objectives of REACH and would be discriminatory and disproportionate.
Additionally they noted that, although the obligation to register monomer substances is identical,
Community manufacturers of polymers are in a position to register those substances more easily
9
Article 138(2) of REACH states that “The Commission may present legislative proposals as soon as a practicable and costefficient way of selecting polymers for registration on the basis of sound technical and valid scientific criteria can be
established, and after publishing a report on the following:
(a) the risks posed by polymers in comparison with other substances;
(b) the need, if any, to register certain types of polymer, taking account of competitiveness and innovation, on the one
hand, and the protection of human health and the environment, on the other.
than are importers inasmuch as they know the composition of their products, whereas importers are,
for their part, subject to the good will of their suppliers outside Community territory.
The case was referred to the European Court of Justice (Case C-558/07) which ruled that the concept
of ‘monomer substances’ in Article 6(3) of the REACH Regulation relates only to reacted monomers
which are integrated in polymers; unreacted manufactured or imported monomers being subject to
registration under Article 6(1) of REACH. The Court also considered whether the obligation to register
monomer substances, satisfying the cumulative conditions laid down in Article 6(3) of REACH,
constitutes a proportionate means to achieve the objectives of that Regulation. The Court noted
that the objectives of the REACH Regulation, set out in Article 1 thereof, are to ‘ensure a high level of
protection of human health and the environment … as well as the free circulation of substances on
the internal market while enhancing competitiveness and innovation. However, having regard to
Recital 16 in the preamble to REACH Regulation, it must be stated that the Community legislature
established, as the main purpose of the obligation to register laid down in Article 6(3) thereof, the
first of those three objectives, namely to ensure a high level of protection of human health and the
environment. The means by which to achieve that objective is, as Recital 19 in the preamble to the
REACH Regulation states, the registration obligation imposed on manufacturers and importers, which
includes the obligation to generate data on the substances which they manufacture or import, to use
those data to assess the risks related to those substances and to develop and recommend
appropriate risk management measures.” The Court also ruled that “Furthermore, where polymers
are imported into the Community, the obligation to register reacted monomers contributes, under
the same conditions, to the protection of human health and the environment, since that obligation
also enables better knowledge to be obtained of polymers. In addition, such an obligation to register
monomers satisfies the precautionary principle as referred to in Article 1(3) of the REACH
Regulation”.
The Court therefore ruled that Article 6(3) of the REACH Regulation was not invalid on the ground
that it infringes the principle of proportionality, or goes beyond that which is necessary to meet the
objectives of the REACH Regulation.
1.6 Nanosilver
One of the fastest moving areas of technological innovation is the field of nanomaterials. A
substance in the nanoscale (defined here as particles with a diameter of less than 100 nanometres)
often has properties quite different from the same material in its bulk form because of the amount of
surface in relation to a particle’s mass. This leads to higher surface reactivity, and interesting
properties can emerge that are increasingly finding their way into products placed on the market.
However, for some nanomaterials, this higher surface reactivity may also be linked to a higher risk of
negative impacts on human health and the environment, and there is growing concern over the lack
of data on the health and environmental impacts of various nanoforms at the same time as the
number of nano-containing products being marketed is rapidly increasing.
At this point few regulatory controls are in place at EU level for nanomaterials, outside of a few
provisions in the 2010 Cosmetics Regulation requiring special assessments and labelling of
nanomaterials in cosmetic products. The position of the Commission, as set forth in a (2008) working
paper, is that nanoforms are fully covered by the current chemicals regulatory regime, i.e., the CLP
Regulation should lead to classification of nanoforms on the market according to their hazardous
properties, and the REACH registration dossiers of the bulk forms of substances should also cover any
special properties of the nanoforms of those substances and assess any associated risks. However,
this position was challenged in (2009?) by the European Parliament, which requested the
Commission to undertake a full review of the chemicals regulatory regime with respect to
nanomaterials – a review which is currently underway.
A 2010 study by Milieu and RPA pointed out that classification of substances under the CLP
Regulation is based on available information only, which provides little incentive for manufacturers
of nanoforms to carry out the testing for specific hazard end-points to see if classification was
necessary. Another obstacle to gathering the data needed to assess the risks with various
nanomaterials is the lack of internationally agreed test methodologies tailored to the particular
characteristics of nanomaterials. An OECD working group has been formed to develop such
methodologies, but progress has been slow.
Nanosilver is one of the nanomaterials which is a focus of particular concern. Metallic silver and
various silver compounds are used in a range of consumer products, because of their anti-microbial
effect. The fibres used in sports clothing and socks labeled as anti-odour have been finished with
nanosilver to counter the microbial decomposition of sweat. Similarly, products labeled as antibacterial, e.g. medical bandages and kitchen cutting boards, are also usually treated with nanosilver
particles. Nanosilver is also found in foods, cosmetics and other articles of daily use. The nanosilver
does not, however, remain in the product. Studies have found that nanosilver used to treat textiles
can wash out as soon as the first laundering, which means that the nanosilver goes into household
wastewater, into the sewage system, and then the aquatic environment at large.
A number of scientific studies have identified harmful impacts on aquatic micro-organisms, and there
is concern that nanosilver going into the food chain may also affect higher levels of the aquatic
ecosystem. An additional concern is whether nanosilver in wastewater will affect the biological
processing systems used in modern wastewater treatment plants.
Recently, in its Opinion No. 24/2010, Germany’s Federal Institute for Risk Assessment (BfR) 10 pointed
out that because of the special physicochemical properties of the nano particle form, a different
toxicological effect potential is known for many nano materials. The opinion -- on toxicity aspects of
nanosilver -- concluded that nanosilver might have a toxicological effect profile with additional toxic
effects not yet described for silver so far. The BfR therefore recommended that nanosilver should
not be used in foods or in articles of daily use until the data situation would allow for a final
assessment of the health risks.
This assessment of nanosilver was objected to mainly by industry on the grounds that enough data
were available for the evaluation of the health risks of nano silver in consumer products and foods. In
order to address this issue, the BfR invited experts from research and science as well as
representatives of associations and industry to a workshop in order to discuss existing risks and
possible options for a comprehensive consumer protection.
After the workshop, the BfR publicly concluded that there continued to be a lack of scientific data
about the specific effects of nano-sized silver particles and therefore its position of caution was
justified. The discussions revealed that only a few toxicological data are available so far on the nano10
The BfR is a scientific institution within the portfolio of the German Federal Ministry of Food, Agriculture
and Consumer Protection (BMELV). It advises on questions of food, chemical and product safety. See BfR
press release on “Safety of nano silver in consumer products: many questions remain open”, 12 April 2011.
specific aspects of silver. Moreover, the characterisation, both for the particles used and for the
dosage, was insufficient because, amongst other things, the corresponding analytical methods were
not available. Many older studies did not meet the standards of modern toxicology, and more recent
studies clearly indicated effects so far not known for silver, including pathological changes of tissues
in the liver after oral and inhalative administration as well as in the lung after inhalative exposure,
changes in physiological parameters of specific organs and a higher potency.
While biocide products based on silver would be examined in the future within the framework of the
biocidal products authorisation procedure, consumer products such as textiles were not subject to a
duty of notification or authorisation. Without an obligation on industry to provide the authorities
with toxicological data for an assessment, the data was lacking so that the health risk of nano silver
containing products could not or could only with difficulty be assessed. Data gaps cited by the BfR
included: lack of data on the release of nano silver particles from textiles and products; possible
threats of resistance against silver or antibiotics in a specific application context; lack of detail
concerning uptake in the human body through the respiratory tract (lung, bronchial tube) and the
resulting distribution of the absorbed particles in the body (toxicokinetics) after inhalation; lack of
data on the effect on skin (sensitisation potential, irritation effect); lack of data on reproduction
toxicity, chronic toxicity and carcinogenic potential.
The BfR pointed to statutory provisions in the German legal system that prohibited the marketing of
articles of daily use and consumer products if they posed any health risks during proper use or
foreseeable misuse. Given the missing data, the BfR concluded that no final safety assessment for
man and the environment could be available so far for nanoscale forms of silver, and therefore it
continues to advise against a broad use of nano silver in consumer products.
The BfR’s opinion is advisory only. It remains to be seen whether it will lead to regulatory action by
Germany and, if so, whether the action will invoke the precautionary principle.
One point for discussion could be that the BfR opinion does not touch on whether the risks to human
health identified to date with respect to nanosilver are “serious” risks. However, the 2001
Communication does not require a showing that the risks identified are considered “serious” as a
threshold for application of a precautionary risk management measure.
Annex 3: Further reading
(Literature list on the Precautionary Principle, human health and the environment)
English, Dutch, German, French and Swedish publications
'Abhandlungen - Das Vorsorgeprinzip - Grundlagen, Massstäbe Und Begrenzungen', Umwelt- Und
Planungsrecht: Zeitschrift Für Wissenschaft Und Praxis, vol. 21/no. 9, (2001), pp. 335-339.
‘A commentary. Canadian Framework for Applying the Precautionary Principle to Public Health
Issues', Canadian Journal of Public Health, vol. 101/no. 5, (2010), pp. 396-399.
'Forum: De Geschiedenis Van Het Voorzorgprincipe', Chemisch2Weekblad: Tweewekelijks Magazine
Voor Biomoleculaire Wetenschappen, Technologie En Chemie: Nieuwsorgaan Van De
Koninklijke Nederlandse Chemische Vereniging, vol. 97/no. 14, (2001), pp. 4.
'Forum: Vraagtekens Bij Het Voorzorgprincipe', Chemisch2Weekblad: Tweewekelijks Magazine Voor
Biomoleculaire Wetenschappen, Technologie En Chemie: Nieuwsorgaan Van De Koninklijke
Nederlandse Chemische Vereniging, vol. 97/no. 13, (2001), pp. 4.
'Stellungnahme - Lebensmittelzusatzstoffe Und Das Vorsorgeprinzip', Lebensmittelchemie : Zeitschrift
d.Lebensmittelchemischen Gesellschaft, Fachgruppe in Der Gesellschaft Deutscher Chemiker,
vol. 55/no. 2, (2001), pp. 49.
'Voorzorgbeginsel Dwingt Tot Diepgaander onderzoek', Chemisch2Weekblad: Tweewekelijks
Magazine Voor Biomoleculaire Wetenschappen, Technologie En Chemie: Nieuwsorgaan Van De
Koninklijke Nederlandse Chemische Vereniging, vol. 97/no. 16, (2001), pp. 5.
'Zorgen Over Het Voorzorgprincipe', Chemisch2Weekblad: Tweewekelijks Magazine Voor
Biomoleculaire Wetenschappen, Technologie En Chemie: Nieuwsorgaan Van De Koninklijke
Nederlandse Chemische Vereniging, vol. 97/no. 15, (2001), pp. 4.
'Vissen Met Voorzorg', Index : Feiten En Cijfers Over Onze Samenleving, no. 5, (2002), pp. 10-11.
'D03-198 - Boek Over Risico's Van Technologie En Het Subtiele Voorzorgsprincipe (New Scientist,
17-05-03)', Selectief, vol. 13/no. 8, (2003).
'PANORAMA - Vorsorgeprinzip: Die EU Macht Es Sich Zu Leicht', DLG-Mitteilungen, vol. 118/no.
11, (2003), pp. 62-65.
'REPORTAGES - Voorzorgprincipe Onder Vuur',
Milieumanagement, vol. 14/no. 9, (2003), pp. 28-29.
MilieuMagazine:
Vakblad
Voor
'Editorial - Die Landwirtschaftliche Klärschlammverwertung Zwischen Vorsorgeprinzip Und
Verhältnismässigkeit', KA Wasserwirtschaft, Abwasser, Abfall, vol. 52/no.
'General Reports of the XVIIth Congress of the International Academy of Comparative Law 16-22
Juillet 2006, Utrecht, Pays-Bas : 16-22 July 2006, Utrecht, the Netherlands = Rapports
Généraux Du XVIIe Congrès De l'Académie Internationale De Droit Comparé', Bruxelles,
Bruylant; Eleven International Publishing, (2007).
'Nanontechnologies - L'afsset. Plaide Pour Le Principe De Précaution', Info Chimie Magazine, no. 489,
(2008), pp. 18-19.
'Nuchterheid Verdwijnt in Voorzorgcultuur - in Gesprek Over Belangrijke Boeken', Spil : Een
Progressief Onafhankelijk Maandblad Voor Zelfstandigen En Werknemers in Het Midden- En
Kleinbedrijf, no. 4, (2008), pp. 5-8.
'Risque Industriel . Téléphonie Mobile . Antenne . Principe De Précaution', Revue De Droit
Immobilier, vol. 30/no. 10, (2008), pp. 493-494.
'Téléphonie Mobilel'Accueil Du Principe De Précaution Dans Un Contentieux De Voisinage', Revue
De Droit Immobilier, vol. 30/no. 10, (2008), pp. 489.
'Trouble Du Voisinage . Risque Créé . Risque Sanitaire . Antenne De Téléphonie Mobile . Principe De
Précaution', Revue De Droit Immobilier, vol. 30/no. 10, (2008), pp. 489-492.
'Rechtsprechung: Zuständigkeit Der Mitgliedsstaaten Zur Festsetzung Für Höchstmengen in Der
Richtlinie 2002/46/EG - Festsetzung Der Höchstmengen Nach Allgemein Anerkannten
Wissenschaftlichen Daten - Vorsorgeprinzip Und Unsicherheiten Bei Der Festlegung Von
Höchstmengen - Festsetzung Der Höchstmengen Und Grundsatz Der Verhältnismäßigkeit',
Zeitschrift Für Das Gesamte Lebensmittelrecht : ZLR, vol. 37/no. 5, (2010), pp. 589-605.
'Verslag Discussie VMR-Studiemiddag 'Bij Twijfel (Niet) Doen? Over de Invulling van het
Voorzorgbeginsel en het Omgaan met Onzekerheden'.', Milieu & Recht, vol. 37/no. 1, (2010), pp.
12-14.
'Événements: 'Armer Face Au Principe De Précaution', Usine Nouvelle : Hebdomadaire De l'Industrie,
no. 3186, (2010), pp. 14-20.
'Intelligences - Débat - Principe De Précaution La Loi Du Risque Maximum?', Industries Et
Techniques, no. 919, (2010), pp. 82-85.
'Dossier: Protéger Nos Ressources En Eau politiques Et Bonnes Politique De l'Eau : Boire Ou Manger,
Faudra-t-Il Choisir ? Lire P. 19. Précautions Pour Limiter Les Pollutions Diffuses : Bonnes
Pratiques Et Aménagements En Vergers. Lire P. 22.', Arboriculture Fruitìere, no. 651, (2010),
pp. 18-28.
'Principe De Précaution Pour Le Patrimoine Monumental . Adoption De La Loi Sur l'Action
Extérieure De l'Etat', L'Actualité Juridique, no. 25, (2010), pp. 1401-1402.
'Urbanisme: Application Du Principe De Précaution à La Délivrance Des Autorisations d'Urbanisme',
Revue De Droit Immobilier, vol. 32/no. 10, (2010), pp. 508-510.
'Droit Des affaires Le Principe Constitutionnel De Précaution', Revue Française De Comptabilité, no.
431, (2010), pp. 12-13.
'The Reality of Precaution: comparing Risk Regulation in the United States and Europe', Washington,
DC etc., RFF, (2011).
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Consultative workshop on considerations to include in the
decision-making process when applying the
precautionary principle
Brussels 5 May 2011
Meeting Report
July 2011
T.M.C. ASSER INSTITUUT
This meeting Report has been prepared by Milieu Ltd, the T.M.C. Asser Institute and PACE for DG
Environment of the European Commission under Study Contract No. ENV.D.3/SER/2010/0083rl, as
background for a consultation workshop that will take place on 5 May 2011 in Brussels.
The views expressed herein are those of the consultants alone and do not necessarily represent the
official views of the European Commission.
Milieu Ltd. (Belgium), rue Blanche 15, B-1050 Brussels, tel: +32 2 506 1000; fax: +32 2 514 3603;
[email protected]; web address: www.milieu.be.
Introduction to the study and the objective of the workshop
This Meeting Report forms part of the study on Technical assistance related to the precautionary
principle in chemicals regulations (ENV.D.3/SER/2010/0083rl), the contract for which is held by
Milieu Ltd, together with the Asser Institute and PACE. The overall aim of the study is to provide
specific recommendations for the Commission on how to practically and properly apply the
precautionary principle (PP) within the regulatory decision-making process in chemicals legislation.
This Meeting Report reflects the discussions from the ‘Consultative workshop on considerations to
include in the decision-making process when applying the precautionary principle’ that took place on
5 May 2011 at DG ENV (Brussels).
The consultative workshop was part of the second part of the project and aimed at bringing together
legal specialists on the precautionary principle and regulatory authorities who take chemicals control
decisions on a day-to-day basis. The aim of the discussions was to link the information gathered to
date on the use of the precautionary principle in the field of human health and the environment to
the technical aspects of chemical legislation. A discussion paper was distributed to the participants
before the workshop to provide them with relevant background information.
The discussion was structured on the basis of proposed steps for guidelines on the application of the
PP in chemicals regulation, and provided an opportunity for innovative thinking on how to apply the
precautionary principle in practice. The main issues discussed considered relevant for further
developing the guidelines are summarised below. A list of participants is attached to this document
(Annex I).
•
Definitions
It was underlined that the Discussion Document should have included various definitions of the PP
and that this would also be useful in the final guidelines.
Reference was made to a working group established by DG SANCO (bringing together chairs of its
risk assessment committees), which is focusing on streamlining and harmonizing the processes and
terminology used in risk assessment, in particular to characterise the concept of 'uncertainty'.
3
In general, the debate between prevention and precaution needs to be elaborated. When taking
regulatory decisions, it is not always necessary to decide for PP measures; sometimes prevention is
sufficient. It is important that this difference is reflected in the final report.
•
The 2000 Communication as starting point
Several participants noted that the proposed guidelines on the application of the PP in chemicals
regulation do not start with a blank sheet: the Communication (COM 2000(1)) lays down a clear set
of principles. Rather than establishing a new set of principles; these guidelines shall function as a
new vehicle to move the application of the principle forward.
Some participants indicated that the ECJ has not really picked up on this Communication, and did
not really flesh it out. Actions of the EU institutions and Member States have not been tested against
the principles laid down in COM(2000)1 by the ECJ.
•
The seriousness of the potential impact on human health and/or the environment
Seriousness is linked to durability and reversibility of the effect. One should ask himself what would
be the consequences in being wrong. These elements should be taken into account while applying the
PP in the chemicals field.
•
Emerging risks
Workshop participants noted that application of PP posed particular problems in the case of
emerging risks linked to certain substances. Though more science was becoming available
concerning potential impacts from endocrine disruptors, other serious risks, such as immune toxicity
or neurotoxicity were still quite speculative because of the lack of scientific data.
•
Elements: avoidance of risk versus a high level of protection
Chemical regulations (such as REACH) aim to achieve a high level of protection. Some participants
considered that this is not the purpose of the PP; rather it aims to avoid “severe irreversible
situations”.
•
Focus on individual substances versus also considering the alternatives
4
PP often covers the phrase “irreversible at the level of the environment”, which in the opinion of
several participants implies a collective risk (not and individual one). Traditionally chemicals
regulation only deals with individual risk, whereas the PP is societal and raises such questions as how
the benefits and costs are distributed. How to bridge the gap between this societal point of view and
the actual impact should be addressed.
Some experts referred to the risk of focusing too much on individual substances. In their opinion, the
PP should be considered from a wider perspective and cover the whole spectrum of risks. For
example, the focus should not only be on phthalates but also on the substances that are brought on
the market as alternatives.
An example is the case of decaBDE. Only looking at this substance is looking at a risk in isolation. For
a broader view, the assessment process should also consider whether there are less toxic
alternatives.
Some participants suggested that during the process of regulation, the availability of alternatives
should always be seen as an element (although this is currently not always the case). Whether or not
a potential risk should be taken also depends on the benefits. The underlying reasoning should
consider why additional risks are taken if alternatives are available.
It was considered essential that information is continuously added on the substance under
discussion as a systematic practice, especially when a hazard is at stake. However, there will never
be that much information on a particular substitute. The paradox is that for the alternative there is
always less information than for the hazardous substance under scrutiny. It is therefore considered
necessary to keep looking at the full picture.
•
Impact of regulatory costs on PP decisions
Several experts mentioned that a coherent policy can only be established when looking at the whole
framework of risk management. It should be taken into account that a risk is easy to regulate if it is
known that cost of regulation are low. A coherent policy requires a framework that is both
qualitative and quantitative in order to guide a regulator in taking decisions on a substance (or set of
substances).
In some situations a trade-off between risks is found. It is important to point out that countries apply
the PP in different ways. There are few simple decisions to prohibit use as all regulations come at a
5
cost. To avoid such trade-offs, it is important that all aspects are transparent. Further, it should be
explained to the public why certain choices are made.
•
(Acceptance of certain) level of uncertainty
One of the main discussion points concerned when a regulator can decide that there is enough
information about uncertainty to make a decision. In this context the Communication requires the
identification of ‘a scientific degree of uncertainty’.
In general, regulators try to avoid situations of uncertainties. An important element of legislation is
that it should create legal certainty: there is an intrinsic difficulty for the regulator in dealing with
uncertainty. However, a back and forth between scientists and decision makers should be avoided. In
science – and the consequential decision-making processes - it should be generally accepted that
uncertainty is the ‘name of the game’.
Moreover, some experts pointed to different types of uncertainties, in other words, not all types of
uncertainties are the same or have the same potential impact. The assessment could further
characterize what elements were uncertain. For example, uncertainty on a substance’s melting point
is not as relevant as uncertainty on whether the substance can result in endocrine disruptions.
Even with a lack of data, past experience on, e.g. genetic hazard relating to a chemicals properties
etc. can provide a good indication of potential hazard. The use of past experience in the process of
assessment is approved by the ECJ.
Some participants noted that in the assessment process, the question of likelihood can be
considered rather than the question of uncertainty. It can be important to identify when there is
enough information to say that it is in a situation of prevention.
Participants shared examples of guidance on dealing with scientific uncertainty prepared by
authorities in France and the UK.
•
Cut-off point
In the process of risk assessment, a cut-off point needs to be established at a certain moment,
despite existing uncertainties. An example mentioned by one of the experts is the family of
brominated flame retardants, such as deca BDE, which although it has not been found to be toxic (as
in PBT), it degrades into Octa and Penta DBE which are toxic which are already restricted in the
Community. Such findings could serve as cut-off points there is no need to establish evidence of
6
toxic levels for 50 species (if toxic levels are found in certain species). However, other experts
underlined the need to consider the toxicity of the alternatives to these flame retardants.
•
Cost-benefit analysis
Several experts noted that it is not always possible to calculate cost-benefits deriving from the use of
a substance due to lack of access to information held by industry. An example mentioned was
phosphates: the benefits of elimination of the phosphates from treated water versus the cost of
waste water treatment to remove them or the impact of substituting them by other chemicals.
Some experts argued it is not always possible quantifying impacts assessment, including cost but
especially environment and health benefits. The risk assessment should not always focus on an
outcome in Euro’s.
•
Involvement of the public
This concept depends on the definition of ‘the public’. These are often stakeholders/industry/NGOs
etc. The level of knowledge should be taken into account before involving the ‘consumer or broader
public’ in decisions on particular chemicals. It was agreed that there is a difference between
involving the public and asking their opinion.
7
Annex 1: list of participants
Name
Affiliation
E-mail address
Philippe Hubert
FR (INERIS)
[email protected]
Robin Foster
UK (International Chemicals
[email protected]
Unit)
Hans Meijer
NL (Ministry of Infrastructure [email protected]
and environment)
Jakob-Matthias
Drossard
DE (Bundesministerium für
[email protected]
Umwelt, Naturschutz und
Reaktorsicherheit
(Chemikalien Risikobewertung und
Risikomanagement )
Elizabeth Heister
Client Earth
[email protected]
David Gee
EEA
[email protected]
Joakim Zander
EFSA
[email protected]
Robert Lindenthal
DG ENTR
[email protected]
Anna Lambers
CEFIC
[email protected]
Erwin Annys
CEFIC
[email protected]
Axel Singhofen
EP
[email protected]
Penelope Vlandas
DG ENV
[email protected]
Christina De Avila
DG ENV
[email protected]
Sebastian Gil
DG ENV
[email protected]
Andrej Kobe
DG ENV
-
Sten-Olov Sodergard
DG CLIMA
[email protected]
Cornelius Rhein
DG CLIMA
[email protected]
Wybe Douma
T.M.C. Asser Instituut
[email protected]
Mark Blainey
PACE
[email protected]
Iona Pratt
Milieu Ltd.
[email protected]
8
Gretta Goldenman
Milieu Ltd.
g.goldenman@milieu .be
Nienke van der Burgt
Milieu Ltd.
[email protected]
9
Annex 5: List of relevant cases on the Precautionary Principle, health and
environment
EU case law
(Since 17/06/1997, source: curia.eu)
Case
Date
C-77/09
C-507/08
Judgment
Opinion
T-532/08
Order
T-539/08
Order
C-77/09
C-343/09
C-343/09
C-446/08
C-453/08
C-379/08
C-380/08
C-105/09
C-110/09
Opinion
Judgment
Opinion
Judgment
Opinion
Judgment
Judgment
Opinion
Opinion
...
C-379/08
...
C-105/09
T-16/04
Judgment
C-209/09
C-333/08
C-446/08
Judgment
Judgment
Opinion
C-390/07
Judgment
T-334/07
Judgment
C-378/08
C-425/08
C-335/07
C-438/07
C-333/08
Opinion
Judgment
Judgment
Judgment
Opinion
T-326/07
Judgment
C-165/08
C-558/07
C-132/08
C-335/07
C-558/07
C-88/07
Judgment
Judgment
Judgment
Opinion
Opinion
Judgment
Parties
2010-12-22 Gowan Comércio
2010-09-09 Commission v Slovakia
Norilsk Nickel Harjavalta and
2010-09-07
Umicore v Commission
Etimine and Etiproducts v
2010-09-07
Commission
2010-07-15 Gowan Comércio
2010-07-08 Afton Chemical
2010-05-06 Afton Chemical
2010-04-29 Solgar and Others
2010-04-29 Karanikolas and Others
2010-03-09 ERG and Others
2010-03-09 ERG and Others
2010-03-04 Terre wallonne
2010-03-04 Terre wallonne
Arcelor v Parliament and
2010-03-02
Council
2010-02-25 Lahti Energia
2010-01-28 Commission v France
2009-12-17 Solgar and Others
Commission v United
2009-12-10
Kingdom
Denka International v
2009-11-19
Commission
2009-10-22 ERG and Others
2009-10-15 Enviro Tech (Europe)
2009-10-06 Commission v Finland
2009-10-06 Commission v Sweden
2009-09-08 Commission v France
Cheminova and Others v
2009-09-03
Commission
2009-07-16 Commission v Poland
2009-07-07 S.P.C.M. and Others
2009-04-30 Lidl Magyarország
2009-03-26 Commission v Finland
2009-03-10 S.P.C.M. and Others
2009-03-05 Commission v Spain
10
C-552/07
Judgment
C-127/07
Judgment
C-121/07
C-317/07
Judgment
Judgment
T-75/06
Judgment
C-452/06
Opinion
T-48/05
Judgment
T-94/98
Judgment
C-188/07
C-140/07
Judgment
Opinion
C-219/07
Judgment
C-76/08 R
C-14/06
C-295/06
Order
Judgment
Judgment
...
C-14/06
T-411/07 R
Order (Summary)
T-411/07 R
Order
C-448/06
C-194/05
C-194/05
C-195/05
C-195/05
C-263/05
C-263/05
C-418/04
C-418/04
C-2/07
T-257/07 R
T-257/07 R
Opinion
Judgment (Summary)
Judgment
Judgment (Summary)
Judgment
Judgment (Summary)
Judgment
Judgment (Summary)
Judgment
Opinion
Order
Order (Summary)
C-439/05 P
...
Judgment
C-454/05 P
C-439/05 P Judgment
T-31/07 R
Order
T-31/07 R
Order (Summary)
T-229/04
T-229/04
Judgment
Judgment (Summary)
2009-02-17 Azelvandre
Arcelor Atlantique and
2008-12-16
Lorraine and Others
2008-12-09 Commission v France
2008-12-04 Lahti Energia
Bayer CropScience
2008-09-09
and Others v Commission
2008-07-10 Synthon
Franchet and Byk v
2008-07-08
Commission
Alferink and Others v
2008-06-26
Commission
2008-06-24 Commune de Mesquer
2008-06-19 Hecht-Pharma
Nationale Raad van
2008-06-19 Dierenkwekers en
Liefhebbers and Andibel
2008-04-24 Commission v Malta
2008-04-01 Parliament v Commission
2008-04-01 Parliament v Commission
Aer Lingus Group v
2008-03-18
Commission
Aer Lingus Group v
2008-03-18
Commission
2008-01-16 cp-Pharma
2007-12-18 Commission v Italy
2007-12-18 Commission v Italy
2007-12-18 Commission v Italy
2007-12-18 Commission v Italy
2007-12-18 Commission v Italy
2007-12-18 Commission v Italy
2007-12-13 Commission v Ireland
2007-12-13 Commission v Ireland
2007-11-29 Abraham and Others
2007-09-28 France v Commission
2007-09-28 France v Commission
Land Oberösterreich v
2007-09-13
Commission
Land Oberösterreich v
2007-09-13
Commission
Du Pont de Nemours (France)
2007-07-19
and Others v Commission
Du Pont de Nemours (France)
2007-07-19
and Others v Commission
2007-07-11 Sweden v Commission
2007-07-11 Sweden v Commission
11
C-132/05
C-173/05
C-439/05 P
C-454/05 P
C-252/05
C-195/05
T-138/03
T-304/01
C-326/05 P
C-173/05
C-418/04
C-176/05
C-486/04
C-504/04
C-98/03
C-98/03
T-369/03
C-11/04
C-12/04
C-194/04
C-453/03
C-6/04
C-6/04
T-235/04
T-366/03
C-154/04
C-155/04
T-158/03
T-158/03
C-86/03
C-270/03
C-6/04
Opinion
Judgment
2007-06-28 Commission v Germany
2007-06-21 Commission v Italy
Land Oberösterreich v
...
Opinion
2007-05-15
Commission
Land Oberösterreich v
C-439/05 P Opinion
2007-05-15
Commission
Judgment
2007-05-10 Thames Water Utilities
Opinion
2007-03-22 Commission v Italy
É.R. and Others v Council
Judgment
2006-12-13
and Commission
Abad Pérez and Others v
Judgment
2006-12-13
Council and Commission
Industrias Químicas del
Opinion
2006-11-30
Vallés v Commission
Opinion
2006-10-05 Commission v Italy
Opinion
2006-09-14 Commission v Ireland
Opinion
2006-09-07 KVZ retec
Opinion
2006-05-30 Commission v Italy
Judgment
2006-01-12 Agrarproduktion Staebelow
Judgment
2006-01-10 Commission v Germany
Judgment (Summary) 2006-01-10 Commission v Germany
Arizona Chemical and Others
Order
2005-12-14
v Commission
...
Judgment
2005-12-06 Fratelli Martini and Cargill
C-11/04
Judgment
2005-12-06 Fratelli Martini and Cargill
Nederlandse Vereniging
Judgment
2005-12-06
Diervoederindustrie Nevedi
Judgment
2005-12-06 ABNA and Others
Commission v United
Judgment
2005-10-20
Kingdom
Commission v United
Judgment (Summary) 2005-10-20
Kingdom
Land Oberösterreich v
T-366/03
Judgment
2005-10-05
Commission
Land Oberösterreich v
...
Judgment
2005-10-05
Commission
Alliance for Natural Health
...
Judgment
2005-07-12
and Others
Alliance for Natural Health
C-154/04
Judgment
2005-07-12
e.a.
Industrias Químicas del
Judgment (Summary) 2005-06-28
Vallés v Commission
Industrias Químicas del
Judgment
2005-06-28
Vallés v Commission
Opinion
2005-06-16 Greece v Commission
Judgment
2005-06-09 Commission v Italy
Opinion
2005-06-09 Commission v United
12
C-132/03
Judgment (Summary)
2005-05-26
C-132/03
Judgment
2005-05-26
C-176/03
Opinion
2005-05-26
C-244/03
Judgment
2005-05-24
C-6/03
Judgment
2005-04-14
Opinion
Opinion
2005-04-07
2005-04-07
C-194/04
Opinion
2005-04-07
C-453/03
Opinion
2005-04-07
C-244/03
Opinion
2005-03-17
C-132/03
Opinion
2005-03-03
T-291/04 R
Order
2005-02-10
Opinion
Opinion
Opinion
Opinion
Opinion
Judgment
Judgment
Judgment (Summary)
Judgment
Opinion
Judgment
Opinion
Judgment
2005-02-03
2005-02-03
2005-02-03
2005-02-03
2005-02-03
2004-12-14
2004-12-02
2004-12-02
2004-11-11
2004-09-23
2004-09-23
2004-09-14
2004-09-07
C-127/02
Judgment
2004-09-07
C-434/02
Opinion
2004-09-07
T-37/04 R
Order
2004-07-07
T-422/03 RII
Order
2004-07-02
C-457/02
C-463/01
C-286/02
C-286/02
Opinion
2004-06-10
Opinion
2004-05-06
Judgment
2004-04-01
Judgment (Summary) 2004-04-01
C-11/04
C-12/04
C-211/03
C-299/03
C-316/03
C-317/03
C-318/03
C-463/01
C-41/02
C-41/02
C-457/02
C-277/02
C-280/02
C-41/02
C-1/03
...
C-11/04
...
C-211/03
C-211/03
C-211/03
C-211/03
Kingdom
Codacons and
Federconsumatori
Codacons and
Federconsumatori
Commission v Council
France v Parliament and
Council
Deponiezweckverband
Eiterköpfe
Fratelli Martini and Cargill
Fratelli Martini and Cargill
Nederlandse Vereniging
Diervoederindustrie Nevedi
ABNA and Others
France v Parliament and
Council
Codacons and
Federconsumatori
Enviro Tech Europe and
Enviro Tech International v
Commission
HLH Warenvertrieb
HLH Warenvertrieb
HLH Warenvertrieb
HLH Warenvertrieb
HLH Warenvertrieb
Commission v Germany
Commission v Netherlands
Commission v Netherlands
Niselli
EU-Wood-Trading
Commission v France
Commission v Netherlands
Van de Walle and Others
Waddenvereniging and
Vogelbeschermingsvereniging
Arnold André
Região autónoma dos Açores
v Council
Enviro Tech Europe and
Enviro Tech International v
Commission
Niselli
Commission v Germany
Bellio F.lli
Bellio F.lli
13
T-177/02
Judgment
2004-03-10
T-177/02
Judgment (Summary)
2004-03-10
C-24/00
C-95/01
Judgment
Judgment
2004-02-05
2004-02-05
T-422/03 R
Order
2004-02-03
C-1/03
Opinion
2004-01-29
C-127/02
Opinion
2004-01-29
C-286/02
Opinion
2004-01-29
T-369/03 R
Order
2004-01-16
T-392/02
Judgment
2003-10-21
C-93/02 P
Judgment
2003-09-30
C-94/02 P
Judgment
2003-09-30
C-192/01
Judgment
2003-09-23
C-236/01
Judgment
2003-09-09
C-393/01
C-93/02 P
Judgment
Opinion
2003-05-22
2003-05-15
C-94/02 P
Opinion
2003-05-15
C-182/02
Opinion
2003-05-06
T-392/02 R
Order
2003-04-11
C-3/00
Judgment
2003-03-20
C-236/01
Opinion
2003-03-13
T-344/00
...
Judgment
2003-02-26
T-345/00
T-344/00
Judgment
2003-02-26
C-393/01
Opinion
2003-01-30
T-147/00
Judgment
2003-01-28
C-192/01
T-132/00
T-137/00
T-141/00
T-74/00
T-76/00
Opinion
Judgment
Judgment
Judgment
Judgment
Judgment
2002-12-12
2002-11-26
2002-11-26
2002-11-26
2002-11-26
2002-11-26
T-74/00
T-74/00
T-74/00
...
T-74/00
Malagutti-Vezinhet v
Commission
Malagutti-Vezinhet v
Commission
Commission v France
Greenham and Abel
Enviro Tech Europe and
Enviro Tech International v
Commission
Van de Walle and Others
Waddenvereniging and
Vogelbeschermingsvereniging
Bellio F.lli
Arizona Chemical and Others
v Commission
Solvay Pharmaceuticals v
Council
Biret International v Council
Etablissements Biret and Cie
v Council
Commission v Denmark
Monsanto Agricoltura Italia
and Others
France v Commission
Biret International v Council
Etablissements Biret & Cie v
Council
Ligue pour la protection des
oiseaux and Others
Solvay Pharmaceuticals v
Council
Denmark v Commission
Monsanto Agricoltura Italia
and Others
CEVA Santé Animale v
Commission
CEVA Santé Animale v
Commission
France v Commission
Laboratoires Servier v
Commission
Commission v Denmark
Artegodan v Commission
Artegodan v Commission
Artegodan v Commission
Artegodan v Commission
Artegodan v Commission
14
T-83/00
T-84/00
T-85/00
C-241/01
C-220/01
T-74/00
T-74/00
T-74/00
Judgment
Judgment
Judgment
Judgment
Opinion
2002-11-26
2002-11-26
2002-11-26
2002-10-22
2002-10-17
T-13/99
Judgment
2002-09-11
T-70/99
Judgment
2002-09-11
C-491/01
Opinion
2002-09-10
C-241/01
C-3/00
C-512/99
C-95/01
Opinion
Opinion
Opinion
Opinion
2002-07-02
2002-05-30
2002-05-30
2002-05-16
C-9/00
Judgment
2002-04-18
C-382/99
C-440/01
P(R)
Opinion
2002-03-14
Order
2002-02-14 Commission v Artegodan
C-9/00
Opinion
T-174/00
Judgment
T-210/00
Judgment
C-248/99 P
Judgment
C-1/00
C-121/00
Avis 2/00
C-1/00
Judgment
Opinion
Opinion
Opinion
C-248/99 P
Opinion
C-248/99 P
Opinion
C-459/00
P(R)
C-471/00
P(R)
C-474/00
P(R)
C-475/00
P(R)
C-476/00
Order
Order
Order
Artegodan v Commission
Artegodan v Commission
Artegodan v Commission
National Farmers' Union
Lennox
Pfizer Animal Health v
Council
Alpharma v Council
British American Tobacco
Investments and Imperial
Tobacco
National Farmers' Union
Denmark v Commission
Germany v Commission
Greenham and Abel
Palin Granit and Vehmassalon
kansanterveystyön
kuntayhtymän hallitus
Pays-Bas v Commission
Palin Granit and Vehmassalon
2002-01-17 kansanterveystyön
kuntayhtymän hallitus
2002-01-11 Biret International v Council
Etablissements Biret & Cie v
2002-01-11
Council
France v Monsanto Company
2002-01-08 (anciennement Pharmacia
Corporation) and Commission
2001-12-13 Commission v France
2001-12-13 Hahn
2001-12-06 Commission
2001-09-20 Commission v France
France v Monsanto Company
2001-06-01 (anciennement Pharmacia
Corporation) and Commission
France v Monsanto and
2001-05-29
Commission
Commission v Laboratoires
2001-04-11
pharmaceutiques Trenker
Commission v Cambridge
2001-04-11
Healthcare Supplies
Commission v Bruno
2001-04-11
Farmaceutici and Council
Order
2001-04-11 Commission v Hänseler
Order
2001-04-11 Commission v Schuck
15
P(R)
C-477/00
P(R)
Order
C-478/00
P(R)
C-479/00
P(R)
C-36/98
C-477/98
Order
Order
Judgment
Judgment
C-352/98 P
Judgment
C-318/98
C-418/97
C-6/99
Judgment
Judgment
Judgment
...
C-352/98 P
Opinion
C-318/98
Opinion
T-13/99 R
Order
C-184/97
Opinion
C-94/98
Opinion
C-293/97
C-284/95
C-341/95
C-67/97
Opinion
Judgment
Judgment
Opinion
Commission v Laboratórios
2001-04-11 Roussel and Laboratoires
Roussel Diamant
Commission v Laboratórios
2001-04-11
Roussel and Roussel Iberica
Commission v Gerot
2001-04-11
Pharmazeutika
2001-01-30 Spain v Council
2000-12-05 Eurostock Meat Marketing
Laboratoires pharmaceutiques
2000-07-04 Bergaderm and Goupil v
Commission
2000-06-22 Fornasar and Others
2000-06-15 ARCO Chemie Nederland
2000-03-21 Greenpeace and Others
Laboratoires pharmaceutiques
2000-01-27 Bergaderm and Goupil
vCommission
1999-09-30 Fornasar and Others
Pfizer Animal Health v
1999-06-30
Council
1999-06-10 Commission v Germany
Rhône-Poulenc Rorer and
1999-05-19
Others
1998-10-08 Standley and Others
1998-07-14 Safety Hi-Tech
1998-07-14 Bettati
1998-06-16 Bluhme
EFTA Court
Case E-3/00 EFTA Surveillance Authority v Norway
WTO
European Communities – Beef Hormones (DS36 and DS320 on continued suspension of obligations)
European Communities - Measures affecting asbestos and asbestos-containing products (DS135)
European Communities – Biotech (DS291)
Japan – Apples (DS236)
ECHR
2009 01 27, TĂTAR v. Romenia, Requête no 67021/01
16
Case
Date
Parties
Legislation
Regulatory
issue
Object
at
risk
of
potential
neg. effect
Conclusion of the court
Substances
at issue
Classification
of substances
2011-0324
(pending)
Nickel
Institute
Dir.
2008/58/EC,
Dir.
67/548/EEC,
Reg. 790/2009,
Reg. 1272/2008
Classification
Human
health,
environment
Nickel
carbonate
compounds
Carcinogenicity
mutagenicity
C-343/09
2010-0708
Afton
Chemical
Dir.
2009/30/EC
Restrictions
Human
health,
atmospheric
pollution
Nickel Institute persuaded the High
Court of Justice (England & Wales) to
ask for a preliminary ruling on the
issue whether, inter alia, there was no
adequate consideration of whether the
intrinsic properties of the contested
substances may present a risk during
normal handling and use. Opinion of
the AG is expected on 24 March 2011.
See also T-532/08 below.
Pending the development of a test
methodology and risk assessment,
MMT use in fuel can be limited based
on contradictory studies.
C-77/09
2010-1222
Gowan
Dir.
91/414/EEC,
Dir.
2006/134/EC
Restrictions on
use
Human health
Methylcycl
opentadien
yl
manganese
tricarbonyl,
MMT
Fenami-rol
T-539/08
2010-0907
Etimine
a.o.
v.
Comm.
Classification as
dangerous
substances
T-532/08
2010-0907
Norilsk
Nickel
a.o.
v.
Comm.
Dir.
2008/58/EC,
Dir.
67/548/EEC,
Reg. 790/2009,
Reg. 1272/2008
Comm.
Dir.
2008/58/EC,
Dir.
67/548/EEC,
Comm.
Reg.(EC)
790/2009, Reg.
(EC) 1272/2008
Classification as
dangerous
substances
Human
health,
environment
C-390/07
2009-1210
Comm. v
UK
&
Ireland
Dir. 91/271/
EEC
Identification of
sensitive areas
Water
sensitive to
eutrophicatio
n
C - ECJ
T - CFI
Opinion
14/10
C-
Although scientific assessments said
the risks were acceptable, these
assessments by rapporteur MS are not
binding on Comm. The potential risk
of endocrine disruption – pending
development of OECD test guidelines
on this aspect – justified restrictions.
Comm. “examined, carefully and
impartially, all the relevant facts of
the individual case, facts which
support the conclusions reached”
(para 57). PP applies where EU takes
measures to protect human health
under CAP.
Inadmissible.
No human toxicological data for
nickel hydroxycarbonate existed, and
companies requested on basis of art.
9(3) Reg. 793/93 to be exempted from
obligation to perform tests and
communicate data on toxicity of
substance for human health and
environment (derogation statement).
Notably based on that statement,
substance was re-classified as cat. 3
mutagens. Applicants did not have
legal standing. In Case C-14/10,
Nickel Institute persuaded the High
Court of Justice (England & Wales) to
ask for a preliminary ruling on this
issue; opinion of the AG is expected
on 24 March 2011.
The MSS should have subjected
certain discharges to more stringent
treatment. The Commission has to
present “at least a certain amount of
Elements of PP
Other sectors
-
Proportionality,
legal
certainty,
equal treatment
Products
Potentially
endocrine
disruptive
Proportionality,
no application of
PP in manifestly
erroneous manner,
integration PP in
other policy areas
Plant Protection
Products
Certain
borates
Toxic
to
reproduction
cat. 2
-
Nickel
carbonate
compounds
Carcinogenicity
, mutagenicity
Nutrients in
waste
water, esp.
compounds
-
Threshold
of
proof, cause and
effect relationship
Water
Case
Date
Parties
Legislation
Regulatory
issue
Object
at
risk
of
potential
neg. effect
C - ECJ
T - CFI
T 75/06
2008-0909
Bayer
CropScie
nce a.o.
v.
Comm.
Dir.
91/414/EEC
Withdrawal of
marketing
authorisation;
Evaluation
procedure
Soil
and
water/sedime
nt
degradation,
Joined cases
C-14/06 and C295/06
2008-0401
EP
v
Comm
Dir.
2002/95/EC,
Comm.
Decision
2005/717/EC
Restriction
use
Environment,
human health
C-446/08
2010-0426
Solgar
Vitamin’
s France
a.o.
Dir.
2002/46/EC
Ban
of
Human
health,
children
as
vulnerable
group
Conclusion of the court
Substances
at issue
evidence” of fulfilment of the
applicable eutrophication criteria, in
particular as regards the significant
adverse environmental effects, and of
the existence of the relationships of
cause and effect.
of nitrogen
and/or
phosphorus
During the evaluation of this active
substance, a number of areas of
concern (like long term risk and
exposure of operators under indoor
conditions)
remained
unsolved.
Assessments made on the basis of the
information submitted did not
demonstrate that it may be expected
that, under the proposed conditions of
use, plant protection products
containing endosulfan satisfy in
general the requirements laid down in
Dir. 91/414. This decision does not
have to take additional information
into account offered after deadlines
had passed. The decision is not
disproportionate either, inasmuch as it
is based on the absence of sufficient
information to show that there were
no risks.
Directive 2002/95 intends to prohibit
certain products and to grant
exemptions only in accordance with
carefully defined conditions. This
objective is in compliance with
Article 152 EC (now 168 TFEU on
public health protection), according to
which a high level of human health
protection is to be ensured in the
definition and implementation of all
Community policies and activities,
and with Article 174(2) EC (now 192
TFEU),
according
to
which
Community
policy
on
the
environment is to aim at a high level
of protection and is based on the PP
and prevention; this justifies the strict
interpretation of the conditions for
exemption. Exemption allowing for
use of substance is annulled.
Where the Comm. did not yet set
maximum levels, MSS must be guided
by the criteria laid down in Dir.
2002/46 on risk assessment based on
generally accepted scientific data.
When it is impossible to calculate
precisely the intake of a mineral from
other dietary sources, a MS may set
the maximum amount at a zero level.
No purely hypothetical considerations,
but if a scientific risk assessment
reveals that scientific uncertainty
Endosulfan
Classification
of substances
Elements of PP
Other sectors
POP, PBT
Proportionality,
time-limits, new
formulation,
Plant protection
products
Decabromo
diphenyl
ether
(‘DecaBDE
’)
Substitution
Fluoride
Proportionality,
Food safety
Case
Date
Parties
Legislation
Regulatory
issue
C - ECJ
T - CFI
Object
at
risk
of
potential
neg. effect
Conclusion of the court
Substances
at issue
Classification
of substances
n-propyl
bromide
highly
flammable,
toxic
for
reproduction in
category 2
Elements of PP
Other sectors
Necessity,
proportionality,
legal certainty
Food safety, free
movement
of
goods
persists as regards the existence or
extent of risks to human health, a MS
may, in accordance with the PP, take
protective measures without having to
wait until the reality and seriousness
of those risks are fully demonstrated.
Where it proves to be impossible to
determine with certainty the existence
or extent of the alleged risk because of
the insufficiency, inconclusiveness or
imprecision of the results of studies
conducted, but the likelihood of real
harm to public health persists should
the risk materialise, the precautionary
principle justifies the adoption of
restrictive measures, provided that
they are non-discriminatory and
objective. Protection of vulnerable
group can be reason to ban for all,
though alternative (labelling) to be
investigated.
C-425/08
2009-1015
Enviro
Tech
C-333/08
2010-0128
Comm. v
France
Dir.
2004/73/EC,
Dir.
67/548/EEC
Classification as
dangerous
substance
Prior
authorisation
scheme
Human health
When the Comm. classifies a
substance, following the opinion of an
expert group, which is based on the
results of a number of tests carried out
using different methods, confirmed by
information taken from specialist
publications, or where it classifies the
same substance following the opinion
of experts, itself based on the criteria
set out in point 4.2.3 of Annex VI to
Directive 67/548 and, in particular, in
point 4.2.3.3 of that annex, the
Commission’s
exercise
of
its
discretion is not vitiated by manifest
error or by an abuse of power and
does not manifestly exceed the limits
of its discretion. The Comm. did not
base its decision on the PP, but on
analyses carried out in accordance
with the methods and the criteria laid
down in Annexes V and VI to
Directive 67/548.
A MS which establishes a prior
authorisation scheme must provide for
a simplified registration procedure and
justify the scheme by demonstrating
the existence of a genuine health risk.
It must demonstrate that the scheme
does not go beyond what is necessary
to attain that objective. To require in
national legislation establishing a
prior authorisation scheme that a
mutual recognition clause be included
would go against the very rationale of
such a scheme, since the MS would be
obliged to allow the marketing on its
territory of processing aids and
Food
processsing aids
Case
Date
Parties
Legislation
Regulatory
issue
C - ECJ
T - CFI
C-165/08
C-558/07
C-552/07
2009-0707
Comm. v
Poland
Dir. 2001/18
S.P.C.M.
Reg. 1907/2006
Azelvand
re
Dir. 2001/18
Object
at
risk
of
potential
neg. effect
Human
health,
environment
Details
of
information to
be provided.
Human
health,
environment
Conclusion of the court
Substances
at issue
Classification
of substances
Elements of PP
foodstuffs benefiting from that clause
without being able to verify the
absence of genuine risks for public
health. Even if, as France claims, in
accordance with the PP the MS
merely has to establish the risk which
the use of processing aids may pose,
the fact remains that the generalised
presumption of a health risk is not
supported by evidence to explain why
the marketing of any foodstuff, in the
preparation of which processing aids
have been used which have been
lawfully
manufactured
and/or
marketed in other MSS, must depend
on the entry of the processing aid in
question on a positive list established
by France, which in turn depends on
the conformity of the foodstuff in
question
with
purity
criteria,
requirements concerning maximum
residual doses or conditions for using
processing aids laid down by that
legislation.
Violation of the applicable directive,
no consideration by the ECJ of aspects
of the PP invoked by Poland.
Directive 2001/18 provides that a
certain amount of information
concerning deliberate releases of
GMOs into the environment cannot be
kept confidential. This is part of a
body of rules relating to the different
procedures applicable to such
releases. Those rules are informed by
the objectives pursued by that
directive, as they are made explicit in
recitals 5, 6, 8 and 10 of that directive,
namely the protection of human
health, the principles that preventive
action should be taken, the
precautionary principle and the
transparency of measures relating to
the preparation and implementation of
those releases. The factors relating to
the geographical location of a
deliberate release of GMOs which
must be included in the notification
thereof fulfil requirements intended to
determine the concrete effects of such
an operation on the environment. The
information concerning the site of
such a release must therefore be
defined according to the nature of
each operation and of its possible
impact on the environment, as is
apparent from the two preceding
Monomer
substances
GMO’s
Nondiscrimination
Other sectors
Case
Date
Parties
Legislation
Comm.
V
Finland
Directive
91/271
Regulatory
issue
C - ECJ
T - CFI
C-335/07
T-334/07
2009-1119
Denka v
Comm.
T-326/07
2009-0903
Chemino
va
v
Comm.
Object
at
risk
of
potential
neg. effect
Environment
Human health
(operators,
workers and
bystanders)
Non-inclusion
in Annex I to
Dir. 91/414
Conclusion of the court
paragraphs.
The Commission does not dispute that
retention is a chemical process which
occurs in water and reduces the
nitrogen concentration, but asserts that
that process cannot be used as a
substitute for removal of nitrogen by
treatment plants as prescribed in
Directive
91/271,
since
that
contradicts the PP. The process of
nitrogen retention does not ensure its
lasting removal and is subject to
seasonal variations, according to the
Comm.
ECJ
finds
that
the
Commission has failed to establish
that the combined effects of reduction
of nitrogen by treatment plants and
natural retention do not enable the
minimum rate of nitrogen reduction
required by Directive 91/271 to be
achieved.
According to EFSA the risk
assessment was inconclusive because
of the gaps in the data submitted by
the applicant, which made it
impossible to set a threshold value.
Notably:
–
no definitive reference value
has been confirmed;
–
as definitive reference values
were not agreed on, the risk
assessment to operators, workers and
bystanders is inconclusive;
–
it is not possible to define a
technical specification for dichlorvos;
–
no analytical methods for
ascertaining the residues of dichlorvos
in soil, water, air, blood and animal
tissues are available.
In view of the PP, the Comm., in light
of available toxicological data,
uncertainties of the genotoxic and
carcinogenic properties and gaps in
the dossier which make it impossible
to carry out a conclusive risk
assessment, did not make a manifest
error of assessment in adopting the
contested decision or infringe Article
5 of Directive 91/414.
It follows from Dir. 91/414,
interpreted in combination with the PP
that, in the domain of human health,
the existence of solid evidence which,
while
not
resolving
scientific
uncertainty, may reasonably raise
doubts as to the safety of a substance,
justifies, in principle, the refusal to
include that substance in Annex I to
Substances
at issue
Classification
of substances
Elements of PP
nitrogen
dichlorvos
malathion
Other sectors
Water
Potential
genotoxic and
carcinogenic
properties
Proportionality,
manifest error of
assessment
Proportionality,
Equal treatment,
sound
administration,
rights of defence
Case
Date
Parties
Legislation
Regulatory
issue
C - ECJ
T - CFI
Object
at
risk
of
potential
neg. effect
Conclusion of the court
Substances
at issue
Classification
of substances
Elements of PP
Other sectors
Necessity,
proportionality
Food safety
the Directive. The PP is designed to
prevent
potential
risks
(Case
T 229/04 Sweden v Commission
[2007] ECR II 2437, paragraph 161).
C-88/07
Comm v
Spain
Joined cases C439/05 P and C454/05 P
2007-0913
Land
Oberöster
-reich
and
Austria
v. Comm
Art. 95
(now
TFEU)
EC
114
T-229/04
2007-0711
Sweden v
Comm
Comm.
Dir.
2003/112/ECam
ending Council
Dir.
91/414/EEC
Human
health,
environment
Authorization
Human health
167 In those circumstances, it is not
necessary to examine whether Article
95(3) EC, which provides that ‘[t]he
Commission, in its proposals …
concerning health … will take as a
base a high level of protection, taking
account in particular of any new
development based on scientific
facts’, is applicable when the
Commission adopts a decision not to
include an active substance in Annex I
to Directive 91/414. Indeed, the
principles of Article 95(3) EC are
reproduced in Article 5(1) of
Directive 91/414, interpreted in
combination with the precautionary
principle.
Spain claims that in the current state
of scientific research, there is
uncertainty
as
regards
the
harmlessness
of
the
products
withdrawn from the market that
justifies their withdrawal under the
precautionary
principle.
ECJ
disagrees: Requirement is that there
be a detailed assessment, on a
case by case basis, of the risk to
public health which the marketing of a
product based on medicinal herbs
might entail. Precautionary
The ECJ dismissed a joined appeal
challenging the decision of the CFI of
5 October 2005 which approved the
decision of the Comm., according to
which the 2002 Upper Austrian law
imposing a general ban on GMOs did
not address a problem specific to the
region; thus it did not fulfil the criteria
of Article 95(5) EC (now 114 TFEU),
which allows for diverting from
harmonised measures. See joined
cases T-266/03 and T-235/04 below.
ECJ annuls Comm. decision to
include paraquat as an active
substance, notably because a foreign
study “appears to constitute solid
evidence which may reasonably raise
doubts as to the safety of paraquat for
operators applying it.” Since that
study attests to a level of exposure
higher than the AOEL in cases where
paraquat was used in accordance with
the recommended conditions, the
requirement laid down in point C
Products
based
on
medicinal
herbs
GMO
Products
paraquat
Plant protection
products
Case
Date
Parties
Legislation
Regulatory
issue
C - ECJ
T - CFI
Joined cases C453/03,
C 11/04,
C 12/04
and
C 194/04
2005-1206
Abna a.o.
Dir. 2002/2/EC
Joined cases T366/03 and T235/04
T-138/03
2005-1005
Austria v
Comm
2006-1213
É. R. a.o.
v Council
and
Comm
Art. 95 EC
(now
114
TFEU)
Art. 288 EC
(now
340
TFEU)
Information
Object
at
risk
of
potential
neg. effect
Human and
animal health
Human
health,
environment
Human health
Conclusion of the court
2.4.1.1 of Annex VI, which prohibits
any exceeding of the AOEL, has not
been fulfilled.
Is an obligation to indicate precise
feed materials contained in compound
feedingstuff is justified on the basis of
the PP in the absence of a risk
assessment, based on scientific
studies,
which
requires
that
precautionary measure on the basis of
a possible correlation between the
quantity of feed materials used and the
risk of the diseases to be prevented?
And proportionate? ECJ: he obligation
to provide customers with exact
indication of the ingredients of a
feedingstuff impacts seriously on the
economic interests of manufacturers,
as it obliges them to disclose the
formulas for the composition of their
products, at the risk of those products
being used as models, possibly by
those customers themselves, and that
the manufacturers cannot obtain the
benefit of the investments which they
have made in terms of research and
innovation. Obligation not justified by
the objective of protecting public
health, as it is pursued and manifestly
goes beyond what is necessary to
attain that objective. It must be
pointed out, inter alia, that this
obligation is independent of any
problem
relating
to
foodstuff
contamination and has to be met only
if the customer so requests.
Furthermore, it is clear from the
explanations provided and from the
examples submitted to the Court that
the indication, on the labelling, of the
percentages within brackets should
normally make it possible to identify a
foodstuff
suspected
of
being
contaminated, in order to assess the
degree of danger which it represents
in relation to the weight indicated and
to decide, if necessary, to withdraw it
temporarily pending the results of
laboratory analyses, or for the
establishment of the traceability of the
product by the public authorities
concerned.
See also appeal in Joined cases C439/05 P and C-454/05 P above.
When damage is caused by conduct of
the Community institutions not shown
to be unlawful, the Community can
incur non-contractual liability if the
Substances
at issue
Classification
of substances
Elements of PP
Other sectors
diverse
Feed saftey
GMO
Goods
BSE
Liability,
safety
food
Case
Date
Parties
Legislation
Regulatory
issue
C - ECJ
T - CFI
Object
at
risk
of
potential
neg. effect
C-132/03
2005-0526
Codacon
s
and
Federcon
su-matori
Reg
(EC)
1139/98,
as
amended
by
Comm.Reg.
(EC) 49/2000
Labelling
Human health
T-177/02
2004-0310
Malagutti
-Vezinhet
v Comm.
Council
Directive
92/59/EEC on
general product
safety
Rapid alert
Human health
C-236/01
2003-0909
Monsant
o
Reg.
258/97
novel food
Human health
Conclusion of the court
conditions as to sustaining actual
damage, to the causal link between
that damage and the conduct of the
Community institutions and to the
unusual and special nature of the
damage in question are all met. No
causal link has been established
between the conduct of the defendants
(alleged late and insufficient handling
of BSE crisis) described by the
applicants and the damage alleged by
the latter (falling ill).
Compulsory indication rules on the
labelling of certain foodstuffs
produced from GMOs of particulars
are to be interpreted as meaning that
the exemption for which it provides
from the obligation, to state on the
labelling of foodstuffs that material
derived from certain GMOs is present,
where such presence is the result of
adventitious contamination and does
not exceed a de minimis threshold of
1% also applies to foodstuffs intended
for the particular nutritional use of
infants and young children. The PP
does not change this.
Under the PP prevailing in the matter
of the protection of public health, the
competent authority may be obliged to
take appropriate measures to prevent
certain potential risks for public health
without having to wait until the
existence and seriousness of those
risks has been fully demonstrated. If it
was necessary to wait until all the
research was completed before
adopting such measures the PP would
be rendered devoid of purpose. That
reasoning also applies in the case of a
rapid information procedure. The
applicant, victim of that alert system
introduced in order to protect human
health, must accept its adverse
economic consequences, since the
protection of public health must take
precedence
over
economic
considerations.
The mere presence in novel foods of
residues of transgenic protein at
certain levels does not preclude those
foods
from
being
considered
substantially equivalent to existing
foods and, consequently, use of the
simplified procedure for placing those
novel foods on the market. However,
that is not the case where the
existence of a risk of potentially
dangerous effects on human health
Substances
at issue
Classification
of substances
Elements of PP
Other sectors
GMO
Food safety
dicofol
Goods,
food
safety,
Plant
protection
substances,
Community rapid
alert system for
food and feed’
(‘RASFF’)
GMO
Food safety
Case
Date
Parties
Legislation
Regulatory
issue
Object
at
risk
of
potential
neg. effect
C - ECJ
T - CFI
C-3/00
2003-0320
Denmark
v Comm
Dir. 95/2/EC,
Dir.
89/107/EEC,
art. 95 EC (now
114 TFEU)
Restrictions
Human health
C-1/00
Comm v
France
Import ban
Human health
T-13/99
Pfizer
Animal
Health
Withdrawal of
authorisation
Human health
C-473/98
Toolex
Restriction
use
on
Conclusion of the court
can be identified on the basis of the
scientific knowledge available at the
time of the initial assessment. It is for
the national court to determine
whether that condition is satisfied.
Protective measures may be taken
pursuant to Article 12 of Reg. No
258/97 interpreted in the light of the
PP even if it proves impossible to
carry out as full a risk assessment as
possible
in
the
particular
circumstances of a given case because
of the inadequate nature of the
available scientific data.
Stricter national rules on food
additives than EU allows for. Comm:
a MS cannot unilaterally invoke the
PP in order to maintain derogating
national provisions. In an area where
MS legislation has been harmonised,
it is for the Community legislature to
apply the PP (para 103). For 2 of the
substances, the Comm decision not
allowing Denmark stricter rules is
annulled by the ECJ, considering an
SCF opinion describing the need to
reduce to a minimum the levels of
nitrites and nitrates added to
foodstuffs.
Lifting partly the export ban for
British beef was held not to be in
violation of the PP; France was not
allowed to upkeep its own, stricter
rules.
Antibiotics in animal feed were
suspected of making bacteria resistant
against these antibiotics, which can
make it harder to threat humans
infected by such bacteria with these
antibiotics.
Authorisation
was
withdrawn. Producer Pfizer pointed at
scientific reports saying the risk was
not acute. ECJ: Risks may not be
purely hypothetical but must be
“adequately backed up with scientific
data” (para 144). The scientific
assessment must be as thorough as
possible (para 162).
Swedish legislation prohibiting use of
a chemical substance for industrial
purposes and establishing a system of
individual exemptions justified under
Art. 36 EC (now 36 TFEU), as it
might result in damage to human
health. The health and life of humans
rank foremost among the property or
interests protected by Art. 36 of the
Treaty. How dangerous to humans
was it? The ECJ took the latest
Substances
at issue
Classification
of substances
Elements of PP
Other sectors
sulphites,
nitrites and
nitrates as
food safety
BSE
Food safety
Virginiamy
cin (an antibiotic)
trichloroeth
ylene
carcinogen
Proportionality,
substitution
Case
Date
Parties
Legislation
Regulatory
issue
C - ECJ
T - CFI
Object
at
risk
of
potential
neg. effect
C-180/96
1998-0505
UK and
Northern
Ireland v
Commiss
ion
Human health
C-157/96
1998-0505
The
Queen v
Ministry
of
Agricultu
re,
Fisheries
and Food
and
Others
Human health
Federal
Administrative
Court
of
Germany (DE)
26-042007
Operator
of
a
thermal
waste
treatment
facility
for
househol
d waste
and
industrial
waste
similar to
househol
d waste
versus
the
competen
t
authority
that
issued
Federal
Immission
Control Act and
Technical
Guideline
for
Clean Air (TALuft)
An amendment
to
the
authorisation set
more
rigid
emission limit
values
for
nitrogen dioxide
and
sulphur
dioxide
Human health
and
the
environment
Conclusion of the court
research on the subject into account indicating a link between exposure to
trichloroethylene and the incidence of
cancer in humans - and also “the
difficulty of establishing a threshold
above
which
exposure
to
trichloroethylene poses a serious
health risk to humans, given the
present state of research.” These
strong
indications
that
trichloroethylene poses a risk to
human health led the ECJ to conclude
that it sees no evidence that national
legislation such as that at issue goes
beyond what is necessary to achieve
the objective in view, in spite of the
fact that the Comm. had claimed the
opposite. Swedish measures were
proportionate.
UK: the risk to human health (if any)
did not justify the contested
decision (export ban British beef)
since it was negligible, having regard
to the measures already adopted, or
related to the period before steps to
control BSE had been taken.
The Comm. adopted the contested
decision (export ban British beef) at a
time when there was great uncertainty
as to the risks posed by UK beef etc.
Where there is uncertainty as to the
existence or extent of risks to human
health, the institutions may take
protective measures without having to
wait until the reality and seriousness
of those risks become fully apparent.
If the national legislation substantiates
the precautionary principle by
adopting technical provisions that lay
down emission limit values for certain
substances, the competent authority is
generally not allowed to require the
compliance with higher or lower
emission values in the authorisation.
A deviation from the adopted
emission values is only permitted in
atypical situations. In atypical
situation the application of the
precautionary principle is restricted by
the principle of proportionality.
Substances
at issue
Classification
of substances
Elements of PP
BSE
BSE
Nitrogen
dioxide and
sulphur
dioxide.
However,
this ruling
applies to
all
substances
falling
under the
Federal
Immission
Control Act
(transpositi
on of IPPC
Directive )
Emission
limit
values
substantiate
the
precautionary
principle and are
binding for the
competent
authorities
and
courts.
Other sectors
Case
Date
Parties
Legislation
Regulatory
issue
Object
at
risk
of
potential
neg. effect
Conclusion of the court
Substances
at issue
Federal
Immission
Control Act and
Technical
Guideline
for
Clean Air (TALuft)
Authorisation to
produce
UVstabilisers
included
emission limit
values for nButylamin
Human health
and
environment
Technical provisions to reduce
emissions must be proportionate to the
risk potential of the substance. From
this the court concluded that under
certain bagatelle thresholds the
adoption of emission limit values is
prohibited.
NButylamin.
However
the
conclusions
of
this
judgement
are
applicable
on
all
measures
that must
be
interpreted
in the light
of
the
precautiona
ry principle
Electricity
supply
and
public health
Secretary
of
State
should
issue
regulations
restricting
electromagnetic
fields
from
electric cables
being laid as
part
of
the
precautionary
principle
and
Article 130r of
EC Treaty.
Instead, the Court of Appeal held that
The Precautionary Principle had no
distinct legal effect in the UK and
Article 130r of EC Treaty did not
impose such an obligation on the
Secretary of State to issue regulations.
An application
was made for a
new
landfill
site. It was
argued
that
planning
Richards J. agreed with the decision in
Duddridge that the principle was not
directly effective at a national level.
He came to the conclusion that the
transposing regulations were merely
“illuminated” by the principle and that
C - ECJ
T - CFI
Federal
Administrative
Court
of
Germany (DE)
2012.1999
R. v Secretary
of State for
Trade
and
Industry
ex
parte Duddridge
and
Others,
Queen's Bench
Division
(Crown Office
List),
The
Times, 26 Oct
1995 (UK)
04/10/94
QBD
R.
v.
Leicestershire
CC ex parte
Blackfordby
and Boothorpe
Action Group
15/03/00
Admn
the
authorisat
ion
for
this
installati
on
Operator
of
an
installati
on
to
produce
UVstabiliser
s
for
coatings
and
plastics
versus
the
competen
t
authority
that
issued
the
authorisat
ion
for
this
installati
on
Waste
Classification
of substances
Elements of PP
Technical
guidelines (here
TA-Luft),
that
substantiate
the
precautionary
principle, must be
interpreted in a
way
that
the
measures
provided for in
these guidelines,
e.g. emission limit
values, must be
sufficient to cover
the potential risk
of the substance.
However,
these
measures
must
also be restricted
to what is strictly
necessary
(principle
of
proportionality).
PP did not lead
the Court to view
that
a
development
should not be
permitted
on
precautionary
grounds relating
to health.
Secretary of State
is not obliged to
adopt
the
precautionary
principle unless
required by an EU
rules or decisions.
The PP in itself
could not be used
to
challenge
national rules or
decisions.
Transposing
regulations were
merely
“illuminated” by
the PP and they
placed no further
Other sectors
Case
Date
Parties
Legislation
C - ECJ
T - CFI
[2001] Env LR
35 (UK)
R
(on
the
application of
Murray)
v.
Derbyshire
County Council,
CO/1493/2000,
6 October 2000,
The Times 8
Nov 2000. (UK)
06/10/00
Admn
Planning
R
(on
the
application of
Amvac
Chemical UK
Limited)
v
Secretary
of
State
for
Environment,
Food
and
Rural
Affairs,
Secretary
of
State
for
Transport,
Local
Government
and
the
Regions, Food
Standards
Agency [2001]
EWHC Admin
1011. (UK)
03/12/01
Admn
Pesticides
Regulatory
issue
permission
should
never
have
been
given, one of
the
reasons
being that the
precautionary
principle should
have prevented
it on the basis
that the impact
of the site on
local
people
was not fully
known.
Concerning an
application for
judicial review
against
a
decision by the
local authority
to grant an
extension for a
landfill
site.
One of the
grounds made
in
the
application was
a failure of the
council to “give
effect to the
precautionary
principle”
An
action
brought by a
pesticide
manufacturer
which sought to
challenge
a
government
decision
to
suspend
regulatory
approvals for a
chemical used
in
pesticides. One
of the grounds,
upon
which
permission for
judicial review
was
granted
was that the
Government
had purported
to follow the
precautionary
principle, but in
Object
at
risk
of
potential
neg. effect
Conclusion of the court
Substances
at issue
Classification
of substances
Elements of PP
they placed no further responsibility
on the responsible authority.
responsibility on
the
responsible
authority.
Justice
Kay
held
that
the
Precautionary Principle was reflected
in both the Waste Framework
Directive and the regulations that
transposed the directive into domestic
law. He refused to consider the
principle as one that was justiciable in
isolation, but saw it as an integral part
of national and EC legislation. Thus, it
was held that by following the
procedure in both the Waste
Framework
Directive
and
the
implementing
legislation,
the
inspector in the case had complied
with the requirements of Article 174
of the EC Treaty
PP considered an
integral part of
national and EC
legislation.
Crane J considered the decision in R
v. Derbyshire County Council and
said “I am prepared to accept that on
a substantive challenge to a
regulatory decision, it may in some
cases be relevant to take into account
the precautionary principle and, more
important its limitations.”
The
decision
suggested that the
courts might be
encouraged
to
give
greater
weight to the PP
in relation to
particular
regulatory
challenges
He also stated that where there are
threats of serious or irreversible
damage, lack of scientific certainty
should not be posed as a reason for
postponing cost-effective measures to
prevent environmental degradation.
However, the application was rejected
on the basis that “There is –at least so
far – no settled, specific or
identifiable mechanism of risk
assessment in the field of pesticide
approval that the Claimant is entitled
to rely on as part of the precautionary
principle, viewed as a separate basis
for challenging a decision.”
Other sectors
Case
Date
Parties
Legislation
Regulatory
issue
C - ECJ
T - CFI
Object
at
risk
of
potential
neg. effect
Conclusion of the court
Substances
at issue
Classification
of substances
Elements of PP
Other sectors
fact had failed
to do so.
Council of State
(FR)
15-122010
Monsant
o versus
the
Ministry
of
Agricultu
re
French register
of varieties of
crops
Inclusion of 17
types of GMOs
to the official
register of
varieties of
crops
(catalogue
officiel
des
espèces
et
variétés
de
plantes
cultivées)
Human
Health and
Environment
The Minsitry of Agriculture could not
invoke the precautionary principle for
the non-inclusion of 17 types of
GMOs to the official register of crops
because it did not base its decision on
the ground of precise elements from
scientific analyses or studies related to
the risks of these GMOs varieties for
human health and the environment.
17 different
types
of
GMOs corn
Council of State
Decision
313547
(FR)
19-032008
Associati
on
of
producers
of corn
(Associat
ion
generale
des
producte
urs
de
Mais)
versus
the
Ministry
of
Agricultu
re
Directive
2001/18/EC
Application of
the
safeguard
clause
under
Directive
2001/18/EC for
OGM
corn
MON 810.
Environment
The Ministry of Agriculture correctly
applied the precautionary principle. It
based its decision to prohibit the
cultivation of OGM corn MON 810
on the ground that the High Authority
on GMOS has provided new facts and
information related to the potential
impact on the environment of the
cultivation of GMOS.
OGM corn
MON 810
Neither the text of the permit nor the
documents referred to in the permit,
on which it is based, make clear that
research as to the potential
consequences of the introduction of
the GM trees into the environment
was carried out with due care.
Notably, it is unclear whether the
various aspects of the steps laid down
in Annex II of Dir. 2001/18 were
taken into account. Research thus
cannot be said to be complete, and all
risks were not investigated and
weighed. Violation of 2 provisions of
GALA demanding gathering all
necessary factual information and
demanding a consistent reasoning.
The Minister should have carried out
hth-, gusen
nptIIgen
The Ministry of
Agriculture
prohibited the
cultivation of
OGM
corn
MON 810
Council of State
of
the
Netherlands,
case
nr.
200304253/1.
(NL)
2004-0728
Greenpea
ce
Netherlan
ds
v
Minister
of
Environ
ment
Dutch decree on
GMO’s based
on
the
Environmentall
y
dangerous
substances Act,
Dir.
2001/18,
General
Administrative
Law
Ac
(GALA)
Permit for field
tests with GM
apple trees
Human health
and
environment
Council of State
2001-04-
Van
Clear
Permit
Environment
der
Act
for
-
The non-inclusion
of
17
types
GMO’s corn by
the Ministry of
Agriculture shall
be
based
on
‘serious indices’
that justify their
reasonable doubts
on the safety of
these types of
GMOS
with
respect to public
health and the
environment and
on the benefit they
can bring with
regard to the
potential risks.
New facts and
new data on the
potential risks to
the environment
of OGM corn
MON
were
enough to justify
the application of
the precautionary
principle
Gathering
available
information,
consistent
reasoning
-
Due
car
all
/
Case
Date
Parties
Legislation
Regulatory
issue
26
EndtLouwerse
et al. v
Minister
of
Transport
, Public
Works
and
Water
Manage
ment
(Ontgrondingen
wet), General
Administrative
Law
Ac
(GALA)
extraction
of
shells in and
around
the
Wadden Sea, a
protected nature
area
Supreme Adm
Court
of
Sweden, case
3846-04;
Rå
2005 Ref. 2
(SE)
2005-0223
Monsant
o v KemI
Dir 97/57;
Dir
2001/99;
Dir 91/414; 14
kap.
14
§
miljöbalken
(1998:808);
KemI issued a
limited
authorisation
instead of a full
one.
Human health
and
environment
Environmental
Appeal Court of
Sweden, case
M7485-04;
MÖD 2005:55
(SE)
2005-1012
Miljönä
mnden i
Landskro
na
kommun
v
Svenska
UMTSnät AB
1 kap. 1 §, 9
kap. 1 § 3 samt
26 kap. 3 § 3 st.
och
21
§
miljöbalken
(1998:808)
A municipality
wanted
locations
of
masts but did
not get these as
they did not
present
an
environmental
risk.
Human health
and
the
environment
C - ECJ
T - CFI
of
the
Netherlands,
case
no.
E01.99.0192 to
E01.99.0197
(NL)
Object
at
risk
of
potential
neg. effect
(protected
nature area)
Conclusion of the court
Substances
at issue
Elements of PP
consistent
reasoning
additional investigations before taking
its decisions in order to obtain a better
understanding of the uncertainties and
flaws that had come to light in the
EIA. The decisions were prepared
without the required due care and
were quashed because they violated
the GALA.
KemI should have substantiated its
decision to limit the authorisation,
notably by conducting an individual
assessment of the substance (the
active substance features on Annex I
Dir 91/414 so an individual
assessment should be carried out).
Instead, its decision was based on the
unsubstantiated general opinion that
pesticides containing glyfoste entail
risks, and on the unsubstantiated
assumption that it will be improperly
handled.
It
is
thus
also
disproportionate, as labelling could
avert risks as well.
Even if an activity is not proven
dangerous for the environment it can
be classified as environmentally
hazardous if there is a risk of impact.
Masts can also cause mental concerns
among local residents, which is
enough for the masts to be considered
to bring harm to the environment
pursuant to Chapter 9. 1 § 3
Environmental Code.
Classification
of substances
glyfosate
UMTS,
radiation
Risk assessment
as far as possible;
proportionality
Other sectors