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 (C-333/08)

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 (C-446/08)

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 two-fold 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 non-discriminatory 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 C-390/07)

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 (C-333/08)

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 98/4851 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 regmeasures 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”.

ulatory

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 principle2. 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. 5 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’).

recent study6 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 low-dose 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 790/20098 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. 8 Commission Regulation (EC) No 790/2009 added the nickel carbonates to the REACH Annex XVII list of substances restricted for use in consumer products.

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 cost-

efficient 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 anti-bacterial, 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 nano- 10 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

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'Stellungnahme - Lebensmittelzusatzstoffe Und Das Vorsorgeprinzip', Lebensmittelchemie : Zeitschrift

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DEFRA, Gui

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

nvironment of the European Commission under Study Contract No. ENV.D.3/SER/2010/0083rl, as ackground for a consultation workshop that will take place on 5 May 2011 in Brussels.

he 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; ienke.vanderburgt@milieu.be

Eb

T

n

; web address: www.milieu.be.

3

troduction to the study and the objective of the workshop

his 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

ilieu Ltd, together with the Asser Institute and PACE. The overall aim of the study is to provide pecific 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 clude 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

ecisions on a day-to-day basis. The aim of the discussions was to link the information gathered to

opportunity for innovative thinking on how to apply the precautionary principle in practice. The main issues discussed considered relevant for further

eveloping the guidelines are summarised below. A list of participants is attached to this document

• 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'.

In

T

Ms

in

ddate 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

d(Annex I).

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 ufficient. It is important that this difference is reflected in the final report.

regulation do not start with a blank sheet: the Communication (COM 2000(1)) lays down a clear set

f principles. Rather than establishing a new set of principles; these guidelines shall function as a

cipants indicated that the ECJ has not really picked up on this Communication, and did ot really flesh it out. Actions of the EU institutions and Member States have not been tested against

• The seriousness of the potential impact on human health and/or the environment

Workshop participants noted that application of PP posed particular problems in the case of merging risks linked to certain substances. Though more science was becoming available

concerning potential impacts from endocrine disruptors, other serious risks, such as immune toxicity r neurotoxicity were still quite speculative because of the lack of scientific data.

hemical regulations (such as REACH) aim to achieve a high level of protection. Some participants

• Focus on individual substances versus also considering the alternatives

s

• The 2000 Communication as starting point

Several participants noted that the proposed guidelines on the application of the PP in chemicals

onew vehicle to move the application of the principle forward.

Some partinthe principles laid down in COM(2000)1 by the ECJ.

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

e

o

• Elements: avoidance of risk versus a high level of protection

Cconsidered that this is not the purpose of the PP; rather it aims to avoid “severe irreversible situations”.

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 egulation only deals with individual risk, whereas the PP is societal and rair ses such questions as how

e benefits and costs are distributed. How to bridge the gap between this societal point of view and the actual impact should be addressed.

ome 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

potential risk should be taken also depends on the benefits. The underlying reasoning should

practice, especially when a hazard is at stake. However, there will never 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

• Impact of regulatory costs on PP decisions

d when looking at the whole amework 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

In some situations a trade-off between risks is found. It is important to point out that countries apply lations come at a

th

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.

S

aconsider why additional risks are taken if alternatives are available.

It was considered essential that information is continuously added on the substance under iscussion as a systematicd

be that much information

necessary to keep looking at the full picture.

Several experts mentioned that a coherent policy can only be establishefr

qualitative and quantitative in order to guide a regulator in taking decisions on a substance (or set of substances).

the PP in different ways. There are few simple decisions to prohibit use as all regu

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

ne of the main discussion points concerned when a regulator can decide that there is enough

avoid situations of uncertainties. An important element of legislation is d create legal certainty: there is an intrinsic difficulty for the regulator in dealing with

ncertainty. However, a back and forth between scientists and decision makers should be avoided. In

Moreover, some experts pointed to different types of uncertainties, in other words, not all types of ncertainties are the same or have the same potential impact. The assessment could further

Even with a lack of data, past experience on, e.g. genetic hazard relating to a chemicals properties tc. can provide a good indication of potential hazard. The use of past experience in the process of

rtainty. It can be important to identify when there is enough information to say that it is in a situation of prevention.

articipants shared examples of guidance on dealing with scientific uncertainty prepared by authorities in France and the UK.

risk assessment, a cut-off point needs to be established at a certain moment, espite existing uncertainties. An example mentioned by one of the experts is the family of

Community. Such findings could serve as cut-off points there is no need to establish evidence of

Oinformation 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 that it shouluscience – and the consequential decision-making processes - it should be generally accepted that uncertainty is the ‘name of the game’.

ucharacterize 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.

eassessment 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 unce

P

• Cut-off point

In the process ofdbrominated 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

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.

held by industry. An example mentioned was hosphates: 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.

ader ublic’ in decisions on particular chemicals. It was agreed that there is a difference between

involving the public and asking their opinion.

• 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 p

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 brop

7

Ann

Name Affiliation E-mail address

ex 1: list of participants

Philippe Hubert FR (INERIS) Philippe.Hubert@ineris.fr

Robin Foster UK (International Chemicals

Unit) Robin.Foster@hse.gsi.gov.uk

Hans Meijer NL (Ministry of Infrastructure

and environment) Hans.Meijer@minvrom.nl

JakDro Umwelt, Naturschutz und

Reaktorsicherheit (Chemikalien - Risikobewertung und

t )

ob-Matthias ssard

DE (Bundesministerium für Jakob-Matthias.Drossard@bmu.bund.de

Risikomanagemen

Elizabeth Heister Client Earth ehiester@clientearth.org

David Gee EEA David.Gee@eea.europa.eu

Joakim Zander EFSA Joakim.Zander@eftasurv.int

Robert Lindenthal DG ENTR Robert.lindenthal@ec.europa.eu

Anna Lambers CEFIC ala@cefic.be

Erwin Annys CEFIC ean@cefic.be

Axel Singhofen EP Axel.singhofen@europarl.europa.eu

Penelope Vlandas DG ENV Penelope.vlandas@ec.europa.eu

Christina De Avila DG ENV Cristina.de-avila@ec.europa.eu

Sebastian Gil DG ENV Sebastian.gil@ec.europa.eu

Andrej Kobe DG ENV -

Sten-Olov Sodergard DG CLIMA Sten-Olov.sodergard@ec.europa.eu

Cornelius Rhein DG CLIMA Cornelius.rhein@ec.europa.eu

Wybe Douma T.M.C. Asser Instituut W.Douma@asser.nl

Mark Blainey PACE mark.blainey@pacesprl.eu

Iona Pratt Milieu Ltd. ipratt@fsai.ie

8

Gretta Goldenman Milieu Ltd. g.goldenman@milieu .be

Nienke van der Burgt Milieu Ltd. Nienke.vanderburgt@milieu.be

9

Annex 5: List of re es on the Pre ealth and environment

U case law

(Since 17/06/1997, source: curia.eu)

Case Date Parties C-77/09

levant cas cautionary Principle, h

E

Judgment 2010-12-22 Gowan Comércio C-507/08 Opinion 2010-09-09 Commission v Slovakia

T-532/08 Order 2010-09-07 Norilsk Nickel Harjavalta and Umicore v Commission

T-539/08 Order 2010-09-07 Etimine and Etiproducts v Commission

C-77/09 Opinion 2010-07-15 Gowan Comércio C-343/09 Judgment 2010-07-08 Afton Chemical C-343/09 Opinion 2010-05-06 Afton Chemical C-446/08 Judgment 2010-04-29 Solgar and Others C-453/08 Opinion 2010-04-29 Karanikolas and Others C-379/08 ... Judgment 2010-03-09 ERG and Others C-380/08 C-379/08 Judgment 2010-03-09 ERG and Others C-105/09 ... Opinion 2010-03-04 Terre wallonne C-110/09 C-105/09 Opinion 2010-03-04 Terre wallonne

T-16/04 Judgment 2010-03-02 Arcelor v Parliament and Council

C-209/09 Judgment 2010-02-25 Lahti Energia C-333/08 Judgment 2010-01-28 Commission v France C-446/08 Opinion 2009-12-17 Solgar and Others

C-390/07 Judgment 2009-12-10 Commission v United Kingdom

T-334/07 Judgment 2009-11-19 Denka International v Commission

C-378/08 Opinion 2009-10-22 ERG and Others C-425/08 Judgment 2009-10-15 Enviro Tech (Europe) C-335/07 Judgment 2009-10-06 Commission v Finland C-438/07 Judgment 2009-10-06 Commission v Sweden C-333/08 Opinion 2009-09-08 Commission v France

T-326/07 Judgment 2009-09-03 Cheminova and Others v Commission

C-165/08 Judgment 2009-07-16 Commission v Poland C-558/07 Judgment 2009-07-07 S.P.C.M. and Others C-132/08 Judgment 2009-04-30 Lidl Magyarország C-335/07 Opinion 2009-03-26 Commission v Finland C-558/07 Opinion 2009-03-10 S.P.C.M. and Others C-88/07 Judgment 2009-03-05 Commission v Spain

10

C-552/07 Judgment 2009-02-17 Azelvandre

-127/07

Judgment 2008-12-16 Arcelor Atlantique and Lorraine and Others C

C-121/07 Judgment 2008-12-09 Commission v France C-317/07 Judgment 2008-12-04 Lahti Energia

-75/06T Judgment 2008-09-09 Bayer CropScience and Others ission v Comm

C-452/06 Opinion 0 n 2008-07-1 Syntho

T-48/05 Judgment 2008-07-08 Franchet and Byk vCommission

T-94/98 Judgment

C-188/07

2008-06-26 Alferink and Others v Commission

Judgment 2008-06-24 Commune de Mesquer C-140/07 Opinion 2008-06-19 Hecht-Pharma

C-219/07

ndibel Judgment 2008-06-19

Nationale Raad vanDierenkwekers en Liefhebbers and A

C-76/08 R alta Order 2008-04-24 Commission v M C-14/06 ... Judgment 2008-04-01 Parliament v Commission C-295/06 C-14/06 Judgment n 2008-04-01 Parliament v Commissio

T-411/07 R mary) v Order (Sum 2008-03-18 Aer Lingus GroupCommission

T-411/07 R p v Order 2008-03-18 Aer Lingus GrouCommission

C-448/06 Opinion 2008-01-16 cp-Pharma C-194/05 ) ion v Italy Judgment (Summary 2007-12-18 Commiss C-194/05 Judgment 2007-12-18 Commission v Italy C-195/05 Judgment (Summary) 2007-12-18 Commission v Italy C-195/05 Judgment 2007-12-18 Commission v Italy C-263/05 Judgment (Summary) C-263/05

2007-12-18 Commission v Italy Judgment 2007-12-18 n v Italy Commissio

C-418/04 ) Judgment (Summary 2007-12-13 Commission v Ireland C-418/04 Judgm ent 2007-12-13 Commission v Ireland C-2/07 Opinion 2007-11-29 Abraham and Others T-257/07 R Order 2007-09-28 France v Commission T-257/07 R mary) Order (Sum 2007-09-28 France v Commission

C-439/05 P

P

... Judgment 2007-09-13 Land Oberösterreich v Commission

C-454/05 P C-439/05 Judgment 2007-09-13 Land Oberösterreich v Commission

T-31/07 R rance) sion Order 2007-07-19 Du Pont de Nemours (F

and Others v Commis

T-31/07 R mary) s (France) n Order (Sum 2007-07-19 Du Pont de Nemour

and Others v Commissio

T-229/04 Judgment n 2007-07-11 Sweden v Commissio T-229/04 ) n Judgment (Summary 2007-07-11 Sweden v Commissio

11

C-132/05 Opinion 2007-06-28 Commission v Germany C-173/05 Judgment 2007-06-21 Commission v Italy

C-439/05 P v ... Opinion 2007-05-15 Land Oberösterreich Commission

C-454/05 P P rreich v C-439/05 Opinion 2007-05-15 Land OberösteCommission

C-252/05 Judgment 2007-05-10 Thames Water Utilities C-195/05 Opinion 2007-03-22 Commission v Italy

T-138/03 uncil ion Judgment 2006-12-13 É.R. and Others v Co

and Commiss

T-304/01 v ommission Judgment 2006-12-13 Abad Pérez and Others

Council and C

C-326/05 P ission

C-173/05

Opinion 2006-11-30 Industrias Químicas delVallés v Comm

Opinion 2006-10-05 Commission v Italy C-418/04 Opinion 2006-09-14 Commission v Ireland C-176/05

Opinion 2006-09-07 KVZ retec

C-486/04 Opinion 2006-05-30 Commission v Italy C-504/04 Judgment 2006-01-12 Agrarproduktion Staebelow C-98/03 Judgment 2006-01-10 Commission v Germany C-98/03 Judgment (Summary)

T-369/03

2006-01-10 Commission v Germany

Order 2005-12-14 d Others

C-11/04

Arizona Chemical anv Commission

... Judgment 2005-12-06 i and Cargill Fratelli MartinC-12/04 C-11/04 Judgment 2005-12-06 Fratelli Martini and Cargill

C-194/04 Judgment 2005-12-06 Nederlandse Vereniging Nevedi Diervoederindustrie

C-453/03 Judgment 2005-12-06 ABNA and Others

C-6/04 Judgment 2005-10-20 Commission v United Kingdom

C-6/04 Judgment (Summary) 2005-10-20 Commission v United Kingdom

T-235/04 T-366/03 Judgment 2005-10-05 Land Oberösterreich v Commission

T-366/03 ... Judgment 2005-10-05 Land Oberösterreich v Commission

C-154/04 ... Judgm alth ent 2005-07-12 Alliance for Natural Heand Others

C-155/04 C-154/04 Judgm alth ent 2005-07-12 Alliance for Natural Hee.a.

T-158/03 Judgment (Summary) 2005-06-28 Industrias Químicas del Vallés v Commission

T-158/03 Judgment 2005-06-28 Industrias Químicas del Vallés v Commission

C-86/03 C-270/03

Opinion 2005-06-16 Greece v Commission Judgment 2005-06-09 Commission v Italy

C-6/04 Opinion 2005-06-09 Commission v United

12

Kingdom

C-132/03 Judgment (Summary)

C-132/03

2005-05-26 Codacons and Federconsumatori

Judgment 2005-05-26 Codacons andFederconsumatori

C-176/03 Opinion 2005-05-26 Commission v Council

C-244/03 Judgment 2005-05-24 France v Parliament and Council

C-6/03 Judgment 2005-04-14 Deponiezweckverband Eiterköpfe

C-11/04 ... Opinion l 2005-04-07 Fratelli Martini and Cargil C-12/04 C-11/04 Opinion 2005-04-07 Fratelli Martini and Cargill

C-194/04 Opinion 2005-04-07 Nederlandse Vereniging Diervoederindustrie Nevedi

C-453/03 Opinion 2005-04-07 ABNA and Others

C-244/03 Opinion 2005-03-17 France v Parliament and Council

C-132/03 Opinion 2005-03-03 Codacons and Federconsumatori

T-291/04 R v Order 2005-02-10 Enviro Tech Europe and Enviro Tech InternationalCommission

C-211/03 ... Opinion 2005-02-03 HLH Warenvertrieb C-299/03 C-211/03 Opinion 2005-02-03 HLH Warenvertrieb C-316/03 C-211/03 Opinion 2005-02-03 HLH Warenvertrieb C-317/03 C-211/03 Opinion 2005-02-03 HLH Warenvertrieb C-318/03 C-211/03 Opinion 2005-02-03 HLH Warenvertrieb C-463/01 C-41/02

Judgment 2004-12-14 Commission v Germany Judgm nds ent 2004-12-02 Commission v Netherla

C-41/02 ) Judgment (Summary 2004-12-02 Commission v Netherlands C-457/02 Judgm

2ent 2004-11-11 Niselli

C-277/0 Trading Opinion 2004-09-23 EU-Wood- C-280/02 Judgment 2004-09-23 Commission v France C-41/02 Opinion Netherlands 2004-09-14 Commission v C-1/03 Judgment 2004-09-07 Van de Walle and Others

C-127/02

Judgment 2004-09-07 g

C-434/02

Waddenvereniging and Vogelbeschermingsverenigin

Opinion 2004-09-07 ré Arnold And

T-37/04 R s

T-422/03 RII

Order 2004-07-07 Região autónoma dos Açorev Council

Order 2004-07-02 l v

C-457/02

Enviro Tech Europe and Enviro Tech InternationaCommission

Opinion 2004-06-10 Niselli C-463/01 y Opinion 2004-05-06 Commission v German C-286/02 Judgment 2004-04-01 Bellio F.lli C-286/02 (Summary) Judgment 2004-04-01 Bellio F.lli

13

T-177/02 Judgment 2004-03-10 Vezinhet v

T-177/02

Malagutti-Commission

Judgment (Summary) 2004-03-10 v Malagutti-VezinhetCommission

C-24/00 Judgment 2004-02-05 Commission v France C-95/01 Judgment 2004-02-05 Greenham and Abel

T-422/03 R ech International v Order 2004-02-03 Enviro Tech Europe and Enviro TCommission

C-1/03 Opinion 2004-01-29 Van de Walle and Others

C-127/02 g Opinion 2004-01-29 Waddenvereniging and Vogelbeschermingsverenigin

C-286/02 Opinion

R

2004-01-29 Bellio F.lli

T-369/03 Order s 2004-01-16 Arizona Chemical and Otherv Commission

T-392/02 Judgment 2003-10-21 Solvay Pharmaceuticals vCouncil

C-93/02 P Judgm nal v Council

C-94/02 P

ent 2003-09-30 Biret Internatio

Judgment 2003-09-30 t and Cie Etablissements Birev Council

C-192/01 Judgment 2003-09-23 Commission v Denmark

C-236/01 Judgment ricoltura Italia 2003-09-09 Monsanto Agand Others

C-393/01 Judgment 2003-05-22 France v Commission C-93/02 P uncil Opinion 2003-05-15 Biret International v Co

C-94/02 P & Cie v Opinion 2003-05-15 Etablissements Biret Council

C-182/02 Opinion 2003-05-06 Ligue pour la protection des

R

oiseaux and Others

T-392/02 Order 2003-04-11 Solvay Pharmaceuticals v Council

C-3/00 Judgment 2003-03-20 Denmark v Commission

C-236/01 Opinion 2003-03-13 Monsanto Agricoltura and Others

Italia

0

T-344/0 ... Judgment 2003-02-26 CEVA Santé Animale v Commission

T-345/00 T-344/00 Judgment 2003-02-26 CEVA Santé Animale v Commission

C-393/01 Opinion 2003-01-30 France v Commission

T-147/00 Judgment n C-192/01

2003-01-28 Laboratoires Servier v Commissio

Opinion 2002-12-12 Commission v Denmark T-132/00 T-74/00 Judgment 2002-11-26 Artegodan v Commission T-137/00 T-74/00 Judgm mmission ent 2002-11-26 Artegodan v Co T-141/00 T-74/00 Judgment 2002-11-26 Artegodan v Commission T-74/00 ... Judgment 2002-11-26 Artegodan v Commission T-76/00 T-74/00 Judgment 2002-11-26 Artegodan v Commission

14

T-83/00 T-84/00

T-74/00 Judgment 2002-11-26 Artegodan v Commission T-74/00 Judgm mmission ent 2002-11-26 Artegodan v Co

T-85/00 T-74/00 Judgment 2002-11-26 Artegodan v Commission C-241/01

Judgment 2002-10-22 ers' Union National Farm

C-220/01

T-13/99

Opinion 2002-10-17 Lennox

Judgment 2002-09-11 Pfizer Animal Health v Council

T-70/99 Judgment

1

2002-09-11 Alpharma v Council

C-491/0

C-241/01

Opinion 2002-09-10 British American TobaccoInvestments and Imperial Tobacco

Opinion 2002-07-02 National Farmers' Union C-3/00 Opinion 2002-05-30 Denmark v Commission C-512/99 Opinion C-95/01

2002-05-30 Germany v Commission Opinion 2002-05-16 Greenham and Abel

C-9/00 Judgment 2002-04-18 Palin Granit and Vehmassalon kansanterveystyön kuntayhtymän hallitus

C-382/99 Opinion 2002-03-14 Pays-Bas v Commission C-440/01 P(R) Order 2002-02-14 Commission v Artegodan

C-9/00 Opinion n

2002-01-17 Palin Granit and Vehmassalokansanterve

ystyön

kuntayhtymän hallitus

T-174/00 Judgment 2002-01-11 Biret International v Council

T-210/00 Judgment

P

2002-01-11 Etablissements Biret & Cie v Council

C-248/99 Judgm

macia ion

ent 2002-01-08 France v Monsanto Company(anciennement PharCorporation) and Commiss

C-1/00 Judgment ion v France 0

2001-12-13 Commiss C-121/0 Opinion 2001-12-13 Hahn Avis 2/00 C-1/00

Opinion 2001-12-06 Commission Opinion 2001-09-20

C-248/99 P

Commission v France

Opinion 2001-06-01 any

ssion

France v Monsanto Comp(anciennement Pharmacia Corporation) and Commi

C-248/99 P santo and

Opinion 2001-05-29 France v MonCommission

C-459/00P(R) Order 2001-04-11 Commission v Laborato

pharmaceutiqires

ues Trenker

C-471/00 P(R) Order 2001-04-11 Commission v Cambridge

Healthcare Supplies

C-474/00P(R) Order 2001-04-11 Commission v Bruno

Farmaceutici and Council

C-475/00 P(R) Order 2001-04-11 Commission v Hänseler

C-476/00 Order 2001-04-11 Commission v Schuck

15

P(R)

C-477/00 P(R) Order 2001-04-11

Commission v Laboratórios Roussel and Laboratoires Roussel Diamant

C-478/00 P(R) Order 2001-04-11 Commiss

Roussel ion v Laboratórios

rica

and Roussel Ibe

C-479/00P(R) Order 2001-04-11 Commission v Gerot

Pharmazeutika

C-36/98 Judgment 2001-01-30 Spain v Council C-477/98 Judgment 2000-12-05 Eurostock Meat Marketing

C-352/98 P res pharmaceutiques

Judgment 2000-07-04 LaboratoiBergaderm and Goupil v Commission

C-318/98 Judgment 2000-06-22 Fornasar and Others C-418/97 ... Judgment 2000-06-15 ARCO Chemie Nederland C-6/99 Judgment

8 P

2000-03-21 Greenpeace and Others

C-352/9 Opinion 2000-01-27 Laboratoires pharmaceutiques Bergaderm and Goupil vCommission

C-318/98 Opinion 1999-09-30 Fornasar and Others

T-13/99 R Order 1999-06-30

7

Pfizer Animal Health v Council

C-184/9 y Opinion 1999-06-10 Commission v German

C-94/98 Opinion 1999-05-19 Rhône-Poulenc Rorer and Others

C-293/97 C-284/95

Opinion 1998-10-08 Standley and Others Judgment 1998-07-14 Safety Hi-Tech

C-341/95 Judgment 1998-07-14 Bettati C-67/97 Opinion 1998-06-16

rt 0 EF Surveillan y v Norway

WTO m ities – Be (DS36 and ons)

European Communities - Measures affecting asbestos and asbestos-coEuropean Communities – Biotech (DS291)

les (DS236)

ECHR 21/01

Bluhme

EFTA CouCase E-3/0 TA ce Authorit

European Co mun ef Hormones DS320 on continued suspension of obligatintaining products (DS135)

Japan – App

2009 01 27, TĂ

TAR v. Romenia, Requête no 670

16

Case C - ECJ T - CFI

Date Parties Legislation Regulatory issue

Object at risk of potential neg. effect

Conclusion of the court Substances at issue

Classification of substances

Elements of PP Other sectors

Opinion C-14/10

2011-03-24 (pending)

Nickel Institute

Dir. 2008/58/EC, Dir. 67/548/EEC, Reg. 790/2009, Reg. 1272/2008

Classification Human health, environment

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.

Nickel carbonate com-pounds

Carcinogenicitymutagenicity

C-343/09 2010-07-08

Afton Chemical

Dir. 2009/30/EC

Restrictions Human health, atmospheric pollution

Pending the development of a test methodology and risk assessment, MMT use in fuel can be limited based on contradictory studies.

Methylcyclopentadienyl manganese tricarbonyl, MMT

- Proportionality, legal certainty, equal treatment

Products

C-77/09 2010-12-22

Gowan Dir. 91/414/EEC, Dir. 2006/134/EC

Restrictions on use

Human health 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.

Fenami-rol Potentially endocrine disruptive

Proportionality, no application of PP in manifestly erroneous manner, integration PP in other policy areas

Plant Protection Products

T-539/08 2010-09-07

Etimine a.o. v. Comm.

Dir. 2008/58/EC, Dir. 67/548/EEC, Reg. 790/2009, Reg. 1272/2008

Classification as dangerous substances

Inadmissible. Certain borates

Toxic to reproduction cat. 2

-

T-532/08 2010-09-07

Norilsk Nickel a.o. v. Comm.

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

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.

Nickel carbonate com-pounds

Carcinogenicity, mutagenicity

C-390/07 2009-12-10

Comm. v UK & Ireland

Dir. 91/271/ EEC

Identification of sensitive areas

Water sensitive to eutrophication

The MSS should have subjected certain discharges to more stringent treatment. The Commission has to present “at least a certain amount of

Nutrients in waste water, esp. compounds

- Threshold of proof, cause and effect relationship

Water

Case C - ECJ T - CFI

Date Parties Legislation Regulatory issue

Object at risk of potential neg. effect

Conclusion of the court Substances at issue

Classification of substances

Elements of PP Other sectors

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

T�75/06 2008-09-

09 Bayer CropScience a.o. v. Comm.

Dir. 91/414/EEC

Withdrawal of marketing authorisation; Evaluation procedure

Soil and water/sediment degradation,

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.

Endosulfan POP, PBT Proportionality, time-limits, new formulation,

Plant protection products

Joined cases C-14/06 and C-295/06

2008-04-01

EP v Comm

Dir. 2002/95/EC, Comm. Decision 2005/717/EC

Restriction of use

Environment, human health

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.

Decabromodiphenyl ether (‘DecaBDE’)

Substitution

C-446/08 2010-04-26

Solgar Vitamin’s France a.o.

Dir. 2002/46/EC

Ban Human health, children as vulnerable group

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

Fluoride Proportionality, Food safety

Case C - ECJ T - CFI

Date Parties Legislation Regulatory issue

Object at risk of potential neg. effect

Conclusion of the court Substances at issue

Classification of substances

Elements of PP Other sectors

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 2009-10-

15 Enviro Tech

Dir. 2004/73/EC, Dir. 67/548/EEC

Classification as dangerous substance

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.

n-propyl bromide

highly flammable, toxic for reproduction in category 2

C-333/08 2010-01-28

Comm. v France

Prior authorisation scheme

Human health 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 process-sing aids

Necessity, proportionality, legal certainty

Food safety, free movement of goods

Case C - ECJ T - CFI

Date Parties Legislation Regulatory issue

Object at risk of potential neg. effect

Conclusion of the court Substances at issue

Classification of substances

Elements of PP Other sectors

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.

C-165/08 Comm. v Poland

Dir. 2001/18 Human health, environment

Violation of the applicable directive, no consideration by the ECJ of aspects of the PP invoked by Poland.

C-558/07 2009-07-07

S.P.C.M. Reg. 1907/2006 Monomer substances

Non-discrimination

C-552/07 Azelvandre

Dir. 2001/18 Details of information to be provided.

Human health, environment

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

GMO’s

Case C - ECJ T - CFI

Date Parties Legislation Regulatory issue

Object at risk of potential neg. effect

Conclusion of the court Substances at issue

Classification of substances

Elements of PP Other sectors

paragraphs. C-335/07 Comm.

V Finland

Directive 91/271

Environment 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.

nitrogen Water

T-334/07 2009-11-19

Denka v Comm.

Human health (operators, workers and bystanders)

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.

dichlorvos Potential genotoxic and carcinogenic properties

Proportionality, manifest error of assessment

T-326/07 2009-09-

03 Cheminova v Comm.

Non-inclusion in Annex I to Dir. 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

malathion Proportionality, Equal treatment, sound administration, rights of defence

Case C - ECJ T - CFI

Date Parties Legislation Regulatory issue

Object at risk of potential neg. effect

Conclusion of the court Substances at issue

Classification of substances

Elements of PP Other sectors

the Directive. The PP is designed to prevent potential risks (Case T�229/04 Sweden v Commission [2007] ECR II�2437, paragraph 161). 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.

C-88/07 Comm v Spain

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

Products based on medicinal herbs

Necessity, proportionality

Food safety

Joined cases C-439/05 P and C-454/05 P

2007-09-13

Land Oberöster-reich and Austria v. Comm

Art. 95 EC (now 114 TFEU)

Human health, environment

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.

GMO Products

T-229/04 2007-07-11

Sweden v Comm

Comm. Dir. 2003/112/ECamending Council Dir. 91/414/EEC

Authorization Human health 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

paraquat Plant protection products

Case C - ECJ T - CFI

Date Parties Legislation Regulatory issue

Object at risk of potential neg. effect

Conclusion of the court Substances at issue

Classification of substances

Elements of PP Other sectors

2.4.1.1 of Annex VI, which prohibits any exceeding of the AOEL, has not been fulfilled.

Joined cases C-453/03, C�11/04, C�12/04 and C�194/04

2005-12-06

Abna a.o. Dir. 2002/2/EC Information Human and animal health

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.

diverse Feed saftey

Joined cases T-366/03 and T-235/04

2005-10-05

Austria v Comm

Art. 95 EC (now 114 TFEU)

Human health, environment

See also appeal in Joined cases C-439/05 P and C-454/05 P above.

GMO Goods

T-138/03 2006-12-13

É. R. a.o. v Council and Comm

Art. 288 EC (now 340 TFEU)

Human health When damage is caused by conduct of the Community institutions not shown to be unlawful, the Community can incur non-contractual liability if the

BSE Liability, food safety

Case C - ECJ T - CFI

Date Parties Legislation Regulatory issue

Object at risk of potential neg. effect

Conclusion of the court Substances at issue

Classification of substances

Elements of PP Other sectors

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).

C-132/03 2005-05-26

Codacons and Federconsu-matori

Reg (EC) 1139/98, as amended by Comm.Reg. (EC) 49/2000

Labelling Human health 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.

GMO Food safety

T-177/02 2004-03-10

Malagutti-Vezinhet v Comm.

Council Directive 92/59/EEC on general product safety

Rapid alert Human health 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.

dicofol Goods, food safety, Plant protection substances, Community rapid alert system for food and feed’ (‘RASFF’)

C-236/01 2003-09-09

Monsanto

Reg. 258/97 novel food

Human health 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

GMO Food safety

Case C - ECJ T - CFI

Date Parties Legislation Regulatory issue

Object at risk of potential neg. effect

Conclusion of the court Substances at issue

Classification of substances

Elements of PP Other sectors

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.

C-3/00 2003-03-20

Denmark v Comm

Dir. 95/2/EC, Dir. 89/107/EEC, art. 95 EC (now 114 TFEU)

Restrictions Human health 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.

sulphites, nitrites and nitrates as

food safety

C-1/00 Comm v France

Import ban Human health 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.

BSE Food safety

T-13/99 Pfizer Animal Health

Withdrawal of authorisation

Human health 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).

Virginiamycin (an anti-biotic)

C-473/98 Toolex Restriction on use

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

trichloroethylene

carcinogen Proportionality, substitution

Case C - ECJ T - CFI

Date Parties Legislation Regulatory issue

Object at risk of potential neg. effect

Conclusion of the court Substances at issue

Classification of substances

Elements of PP Other sectors

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.

C-180/96 1998-05-05

UK and Northern Ireland v Commission

Human health 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.

BSE

C-157/96 1998-05-05

The Queen v Ministry of Agriculture, Fisheries and Food and Others

Human health 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.

BSE

Federal Administrative Court of Germany (DE)

26-04-2007

Operator of a thermal waste treatment facility for household waste and industrial waste similar to household waste versus the competent authority that issued

Federal Immission Control Act and Technical Guideline for Clean Air (TA-Luft)

An amendment to the authorisation set more rigid emission limit values for nitrogen dioxide and sulphur dioxide

Human health and the environment

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.

Nitrogen dioxide and sulphur dioxide. However, this ruling applies to all substances falling under the Federal Immission Control Act (transposition of IPPC Directive )

Emission limit values substantiate the precautionary principle and are binding for the competent authorities and courts.

Case C - ECJ T - CFI

Date Parties Legislation Regulatory issue

Object at risk of potential neg. effect

Conclusion of the court Substances at issue

Classification of substances

Elements of PP Other sectors

the authorisation for this installation

Federal Administrative Court of Germany (DE)

20-12.1999

Operator of an installation to produce UV-stabilisers for coatings and plastics versus the competent authority that issued the authorisation for this installation

Federal Immission Control Act and Technical Guideline for Clean Air (TA-Luft)

Authorisation to produce UV-stabilisers included emission limit values for n-Butylamin

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.

N- Butylamin. However the conclusions of this judgement are applicable on all measures that must be interpreted in the light of the precautionary principle

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).

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

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.

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.

R. v. Leicestershire CC ex parte Blackfordby and Boothorpe Action Group

15/03/00 Admn

Waste 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

Transposing regulations were merely “illuminated” by the PP and they placed no further

Case C - ECJ T - CFI

Date Parties Legislation Regulatory issue

Object at risk of potential neg. effect

Conclusion of the court Substances at issue

Classification of substances

Elements of PP Other sectors

[2001] Env LR 35 (UK)

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.

they placed no further responsibility on the responsible authority.

responsibility on the responsible authority.

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 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”

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.

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)

03/12/01Admn

Pesticides 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

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.” 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.”

The decision suggested that the courts might be encouraged to give greater weight to the PP in relation to particular regulatory challenges

Case C - ECJ T - CFI

Date Parties Legislation Regulatory issue

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)

15-12-2010

Monsanto versus the Ministry of Agriculture

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

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.

Council of State Decision 313547 (FR)

19-03-2008

Association of producers of corn (Association generale des producteurs de Mais) versus the Ministry of Agriculture

Directive 2001/18/EC

Application of the safeguard clause under Directive 2001/18/EC for OGM corn MON 810. The Ministry of Agriculture prohibited the cultivation of 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

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

Council of State of the Netherlands, case nr. 200304253/1. (NL)

2004-07-28

Greenpeace Netherlands v Minister of Environment

Dutch decree on GMO’s based on the Environmentally dangerous substances Act, Dir. 2001/18, General Administrative Law Ac (GALA)

Permit for field tests with GM apple trees

Human health and environment

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.

hth-, gus- en nptII-gen

Gathering all available information, consistent reasoning

Council of State 2001-04- Van der Clear Act Permit for Environment The Minister should have carried out - - Due car /

Case C - ECJ T - CFI

Date Parties Legislation Regulatory issue

Object at risk of potential neg. effect

Conclusion of the court Substances at issue

Classification of substances

Elements of PP Other sectors

of the Netherlands, case no. E01.99.0192 to E01.99.0197 (NL)

26 Endt-Louwerse et al. v Minister of Transport, Public Works and Water Management

(Ontgrondingenwet), General Administrative Law Ac (GALA)

extraction of shells in and around the Wadden Sea, a protected nature area

(protected nature area)

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.

consistent reasoning

Supreme Adm Court of Sweden, case 3846-04; Rå 2005 Ref. 2 (SE)

2005-02-23

Monsanto 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

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.

glyfosate Risk assessment as far as possible; proportionality

Environmental Appeal Court of Sweden, case M7485-04; MÖD 2005:55 (SE)

2005-10-12

Miljönämnden i Landskrona kommun v Svenska UMTS-nät 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

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.

UMTS, radiation