Agenda Item 4

OSPAR 99/4/NGO... -E

English only

OSPAR CONVENTION FOR THE PROTECTION OF THE MARINE ENVIRONMENT OF THE NORTH-EAST ATLANTIC

MEETING OF THE OSPAR COMMISSION

KINGSTON UPON HULL: 21-24 JUNE 1999

________________________________________________________________________

 

Implementation of OSPAR strategy and Sintra statement with regard to hazardous substances needs action on EU level by OSPAR contracting parties

Presented by

Seas At Risk

Background

1. Reference is made to the OSPAR strategy with regard to hazardous substances and to the Sintra Statement.

2. Cross reference is made to documents HOD(1) 98/4/NGO.2 and HOD(2) 98/7/NGO.2 where Seas At Risk explains the discrepancy between the draft Water Framework Directive and the OSPAR objective with regard to hazardous substances.

3. Seas At Risk expresses concerns arising from the slow progress made by OSPAR in implementing the new objective with regard to hazardous substances, and from the lack of effort made by most contracting parties to implement the objective at national and international level, and especially at the level of the EU.

4. OSPAR’s attention is drawn to the attached comparison between the OSPAR objective, the EU Water Framework Directive and EU Chemicals Legislation (see annex). This paper was produced in cooperation with other international environmental NGOs.

Action requested

OSPAR is invited to consider the attached with a view to taking appropriate action.

 

Implementation of OSPAR strategy and Sintra statement with regard to hazardous substances needs action at EU level by OSPAR contracting parties

1. Seas At Risk is concerned that in the last year no significant progress has been made on OSPAR’s current priority list of hazardous substances despite the fact that the list consists primarily of substances which we have know for some time are hazardous. In light of this we would like to take the opportunity to urge OSPAR to revise the current operations of its working groups and of work delegated to lead countries to provide an effective, flexible and strong decision-making process capable of reaching the OSPAR objective.

2. Seas At Risk welcomes the progress made by the ad-hoc working group on the dynamic selection and prioritisation scheme (DYNAMEC) although we note that a significant part of the progress (e.g., the concept for assessment of risk) is due to work carried out by the European Chemical Bureau (ECB) (on assessment of risk) and by Denmark and the Netherlands (on the initial selection procedure).

3. Seas At Risk acknowledges the work being done by the ECB to adapt the current EU risk assessment procedure to the requirements of the OSPAR objective, but we see no consequent and consistent effort by OSPAR contracting parties and their national ministers to implement the requirements of the OSPAR objective in all relevant EU legislation.

4. Even with an appropriate revision of the operations of OSPAR’s working groups the OSPAR objective with regard to hazardous substances will not be reached by OSPAR work alone. It is clear that fulfillment of the objective requires implementation at a national and international level and we trust that ministers having agreed to "make every endeavour to move towards the target of cessation of discharges, emissions and losses of hazardous substances by the year 2020" and to "invite …other international organisations to join us in these efforts to achieve this target", are aware of this fact.

5. At present Seas At Risk sees no sign of this promised strength of will within either the EU chemical policy review process or the negotiations for the EU water framework directive (see annex). With twelve of the fifteen EU member states also contracting parties to OSPAR it is difficult to see why the same ministers who adopted the Sintra statement protecting the marine environment are not willing to agree on an equivalent degree of protection for European rivers, which are after all the main source of marine pollution.

6. Seas At Risk urges OSPAR contracting parties to take a consistent approach and work for full implementation of the OSPAR objective at national and international level, and especially at EU level.


 

 

ANNEX

THE WATER FRAMEWORK DIRECTIVE AND THE REGULATION OF HAZARDOUS CHEMICALS

 

Contents

Part A: Background and Summary

Part B: Detailed Analysis of Council and EP Positions

B 1 Objectives and the underlying concept of risk

B 2 Implementation of the Precautionary Principle

B 3 Risk Management and concrete legal measures

Part C: Synopsis Table

 

PART A: BACKGROUND AND SUMMARY

The scope of the Water Framework Directive

For many years, environmental organisations have been demanding that Europe's waters - both inland fresh waters and the seas -be efficiently protected from the potential adverse effects of hazardous substances. The Water Framework Directive (WFD) whose objective it is to protect and enhance the quality and ecological status of European waters is the obvious tool to establish the respective rules as binding EU law. The directive should therefore reflect the following principles:

    • protection of all waters against pollution not accepting the long term occurrence of hazardous substances in the environment;
    • a concrete date for the cessation of discharges, emissions and losses of hazardous substances into the environment analogous to the OSPAR 2020 goal;
    • precautionary action as the rule, i.e. to base the identification of hazardous substances on their intrinsic chemical, physical and biological properties and not to wait for adverse effects to occur before taking action;
    • creation of uniform economic conditions for manufacturers and commercial users of chemicals throughout the European Union.

OSPAR 1998 - leading the way

In June 1998, Europe took an important step towards precautionary control of hazardous substances. In their meeting in Sintra in Portugal, the contracting parties to the Oslo and Paris Convention represented by their environmental ministers agreed 'to move towards the target of the cessation of discharges, emissions and losses of hazardous substances by the year 2020', 'with the ultimate aim of achieving concentrations in the marine environment near background values for naturally occurring substances and close to zero for man-made synthetic substances'.

At the same time the term 'hazardous substances' was clearly and unambiguously defined. It means substances which are toxic, persistent and bioaccumulative plus substances which - though not necessarily meeting all these criteria - give rise to an equivalent level of concern, for instance highly persistent and bioaccumulative substances with no or unknown toxic properties. The term 'toxic' also covers inter alia endocrine disrupting effects and toxic effects which cannot be quantified, but may be caused by very small concentrations.

OSPAR´s Sintra Statement (excerpt)

We agree to prevent pollution of the maritime area by continuously reducing discharges, emissions and losses of hazardous substances (that is, substances which are toxic, persistent and liable to bioaccumulate or which give rise to an equivalent level of concern), with the ultimate aim of achieving concentrations in the environment near background values for naturally occurring substances and close to zero for man-made synthetic substances.

We shall make every endeavour to move towards the target of cessation of discharges, emissions and losses of hazardous substances by the year 2020.

We emphasize the importance of the precautionary principle in this work.

The missing link - OSPAR and WFD

OSPAR's Sintra statement can be said to fully reflect the concerns and recommendations of Europe's environmental NGOs about hazardous substances. Its objective should be adopted and elaborated by the EU Water Framework Directive in order to protect all inland ground and surface waters from hazardous substances, as well as to help achieve the objective for the marine environment.

Incorporating the OSPAR objectives into binding EU legislation is not merely an option, it is an obligation. By signing the Sintra statement, the European Commission as contracting party to OSPARCOM and the European Council represented by 12 of the 15 EU environment ministers have taken on a political and moral responsibility to implement the OSPAR objective in EU legislation.

However, the principles laid down by OSPAR are reflected neither by the directive originally proposed by the Commission nor by the text amended by the Council and adopted as Common Position in March 1999. It is difficult to conceive why the same ministers who have adopted the Sintra statement protecting the marine environment are not willing to agree on an equivalent degree of protection for European rivers, the main sources of marine pollution.

European Parliament's demands WFD to reflect OSPAR

It is highly welcome that the European Parliament has fully adopted the Sintra principles in its first reading of the Water Framework Directive in February 1999. The Parliament requests that

    • the cessation of discharges, emissions and losses of hazardous substances by 31 December 2020 be made a legally binding goal of the Directive (Article 1);
    • hazardous substances be identified on the basis of their chemical, physical and biological properties in analogy to the OSPAR definition of hazardous substances (Article 2);
    • a target list of hazardous substances be established (Article 21(5a)). This target list is to indicate the totality of hazardous substances to be regulated by 2020 (mirroring the requirements of the OSPAR objective);
    • for data-deficient potentially hazardous substances the producer, trader and/or professional user shall supply the standard data set of chemical, physical and biological properties; if the standard data set has not been supplied by 31 December 2003, the substance shall be regarded as hazardous and added to the target list (Article 21(5b)).

In short, the amendments brought forward by the European Parliament are deemed an equivalent transcription of OSPAR rules into EU legislation.

PART B: Detailed Analysis of Council and

European Parliament positions

The following analysis aims to facilitate the comparison of Council and Parliament positions on the legal regime of hazardous substances under the Water Framework Directive. The crucial article in the WFD in this context is Article 21 ('Strategies against pollution of water') in which objectives, timetables and the target group of substances for Community-wide measures are laid down.

The analysis looks at the following core concepts of hazardous chemicals regulations:

    1. Objectives and the underlying concept of 'risk'
    2. Implementation of the precautionary principle
    3. Risk management and concrete legal measures

The Parliament's First Reading and the Council's Common Position are analysed for each of the above aspects and compared with existing Community chemicals law. In summary, the Council position differs only slightly from the current inefficient legislation, whereas Parliament's approach can be said to fully reflect OSPAR principles.

Finally, to further facilitate the comparison, the results are summarised in Table 1 at the end of the text.

B 1 Objectives and the underlying concept of 'risk'

B 1.1 Parliament aims to implement OSPAR objective in WFD

The amendments passed by Parliament in its first reading on 11 February 1999 implement the OSPAR objective including its deadline (2020) as a purpose of the Directive in Article 1 in a legally binding way ('The overall perspective of this Directive is to establish a framework for the protection of inland surface water, transitional water, coastal waters and groundwater which phases out discharges, emissions and losses of hazardous substances into the aquatic environment by the year 2020'). The legal definition suggested by the EP for hazardous substances (Article 2) is identical with OSPAR wording.

Furthermore, the Parliament requests a new procedure establishing 'a target list of substances which are potentially hazardous on the basis of their chemical, physical and biological properties' (new Article 21(5a)). These substances are thus subject to regulation aiming at the cessation of discharges, emissions and losses by 2020. The deadline for the establishment of the target list is 30 June 1999.

The EP further suggests a new paragraph 21(5b) dealing with substances for which the necessary data set does not exist. Such substances will automatically be included in a list of 'data-deficient potentially hazardous substances'. Article 21(5b) concludes: 'Potentially hazardous substances for which no standard data set has been supplied by 31 December 2003 shall be regarded as hazardous substances and added to the target list.'

B 1.2 Council version in contradiction to OSPAR objectives

The Council Common Position introduces the concept of 'risk assessment' into the Water Framework Directive. Legal action is limited to chemicals 'presenting an unacceptable risk to or via the aquatic environment' (Article 21(1)). Before any measures can be taken, an unacceptable risk has to be proven using a substance-by-substance risk assessment procedure.

The Council Common Position clearly ignores the objective agreed under OSPAR and in contrast accepts the general occurrence of hazardous substances in the environment. Specifically, it fails to define the target group of substances that need regulation. There is no definition and actually no mention of the term 'hazardous substances' in the Council text. Therefore, the need to reduce pollution by hazardous substances is not a general legal requirement as under OSPAR, but would have to be proven and justified for each single substance. Clearly, the Council Common Position of the Water Framework Directive will not result in a reduction of pollution from hazardous substances. Furthermore, no deadline analogous to the OSPAR 2020 goal has been set by the Council.

The number of substances to be acted upon in the first six year period of the Directive's implementation has been arbitrarily limited to 30 substances ('for practical reasons'). After six years, this first priority list of 30 is to be 'reviewed'. However, many regulators and industry apparently regard these 30 substances as the total group to be assessed for legal action, with only a few single substances to be added later. It is obvious that this approach is inadequate to deal with the much larger number of potentially hazardous substances in the environment.

In summary, regarding hazardous substances, there is little difference between the existing insufficient EU chemicals legislation (see B 1.3) and the Council Common Position on the Water Framework Directive.

B 1.3 Existing Chemicals legislation in conflict with OSPAR objective

The existing chemicals legislation was originally designed to establish a common market for the movement of goods, including chemical substances. Protection goals with regard e.g. to human health and the environment were introduced later. They are generally limited to preventing 'unacceptable risks' to humans and selected ecosystems by assessing the possible effects of chemical substances.

In comparison with OSPAR this view is out-dated and insufficient and fails to take into account the revisions of the Treaty that have taken place since that legislation was adopted. It is based on

    • the general long-term acceptance of hazardous substances in the environment, i.e. lacking perspective to cease the occurrence of these substances in the environment and in violation of the Treaty principle of prevention at source. No restriction applies unless the "risk" posed by substances is proven.
    • an understanding of risk which is solely based on the assessment of a limited number of observable effects which can be linked to a single substance. Scientific knowledge about the limitation of this approach is ignored (e.g. combined effects, lack of correlation between concentration and effect, long-term effects, endocrine disrupting effects and other non-quantifiable effects, unknown effects).
    • The procedure laid down in Regulation (EEC) No. 793/93 on risk assessment of existing chemicals has proven over the years to be ineffective in protecting the environment. Not only is it cumbersome and time-consuming, when taking account of economic factors, it only stresses the costs for industry. Even if a public health or environment risk is identified, an additional analysis is undertaken to justify regulatory action ('unacceptable risk'.)

B 2 Implementation of the Precautionary Principle

B 2.1 Parliament's precautionary approach to select substances for action

According to the European Parliament's amendments, the target list containing the totality of substances with a potential need for regulation shall be established by an additional procedure (Article 21(5a)) and be based on the chemical, physical and biological properties of substances. This initial selection shall be improved and accelerated by obliging industry to provide data by a certain deadline, after which substances without a database will be automatically classified as 'hazardous'. [A similar approach was suggested by the EU Environment Council in Chester in 1998, where a deadline for classification was proposed, but not adopted].

Legislative action shall concentrate first on the substances from the target list posing the highest relative risk. These should be selected by the priority setting procedure outlined in Article 21(2) of the Directive. However, the EP asks for further sets of hazardous substances to be dealt with every three years thereby establishing a dynamic process to treat all hazardous substances until 2020 (instead of the doubtful six-yearly review process proposed by the Council).

In this context, the prioritisation procedure developed by the Commission ('Combined monitoring-based and modeling-based priority setting scheme' COMMPS) is regarded as useful. Applied to the relative ranking of hazardous substances (based both on intrinsic properties and on predicted exposure), it can become an efficient tool for the dynamic selection of priority substances. However, it should be kept in mind that according to the Parliament concept, COMMPS is NOT a tool to identify target substances, but merely a tool to prioritise substances on the target list for action.

B 2.2 Council's focus on risk assessment

By introducing the term 'unacceptable risk' in the opening paragraph of Article 21 of the Water Framework Directive, the Council makes risk assessment a precondition for Community-wide regulatory measures on chemicals. Thus, the current philosophy of EU chemicals legislation is fully taken over into the Water Framework Directive (see B 2.3). Although the WFD is meant to be not a product Directive but an environmental Directive, it puts the burdon of proof entirely on the environment rather than on pollutants.

It is highly welcome that the selection method for the creation of the priority list established by Council in Article 21(2) includes elements which deviate from the path of the usual full EU risk assessment (Regulation (EEC) No. 793/93). However, these positive elements are superseded by the introduction of the term 'unacceptable risk' in Article 21(1) which calls for a risk assessment to be applied. In other words: The tools listed in Article 21(2) are only meant for establishing a priority list, but a risk assessment will be performed before any measures regarding these priority substances are taken.

The proposed procedure will turn out to be ineffective

    • because a very small number of substances will be regulated at all (short priority list of only 30 substances, burden of proof wholly on the environment);
    • because only few of the selected priority list substances will be deemed to pose an 'unacceptable risk' after risk assessment.

It is difficult to understand why the Council keeps ignoring the precautionary principle in the field of chemicals policy while insisting on it in international forums. For instance, in the Commission's WTO beef hormones appeal, the Legal Service argued that 'the EC considers that it is for those applying for authorisation to establish that a substance is safe [their emphasis], and that 'the precautionary principle is already, in the view of the EC and its Member States, a general customary rule of international law or at least a general principle of law.‘ They also put commercial interests (in trade terms) below human health, saying 'it is not sufficient to lay down basic trading rights without demonstrating at the same time how its system can successfully take account of human rights, health and other global concerns.‘

The Water Framework Directive is the obvious opportunity to apply those principles to the protection of the Community's waters against pollution from hazardous substances.

B 2.3 Existing chemicals legislation ignores precautionary principle

The currently used risk assessment for existing substances in the EU (Regulation (EEC) No. 793/93) is based solely on proven scientific knowledge about selected effects (see above, B 1.3). The burden of proof is on the environment because a risk is only identified when environmental effects are scientifically proven. Under existing chemicals legislation, there is no way to regulate substances without a full risk assessment, and no way to identify a risk other than by the existing procedure.

The risk assessment procedure includes an evaluation of economic costs for industry deriving from eventual restrictive measures. So even if a risk is identified by the assessment procedure, measures will not be taken in case costs for industry are deemed unacceptable.

The current risk assessment for existing substances has proven to be an extremely ineffective process and as such unable to deal with the large number of potentially dangerous substances. Within six years only 20 substances have been assessed, four of them addressed by draft control recommendations. No restrictions or reduction measures have been taken on the basis of this risk assessment procedure so far.

B 3 Risk Management and concrete legal measures

B 3.1 Parliament aims to cease releases by 2020

Again, Parliament has taken on board OSPAR objectives: It wants to regulate a new lot of hazardous substances selected from the target list every three years. Community-wide uniform measures would be taken with the objective to put an end to discharges, emissions and losses into the aquatic environment by the year 2020. Within the 20 years until then, step by step, all hazardous substances would be assessed and regulated.

B 3.2 Doubtful link between risk assessment and legal measures

In contrast to the European Parliament's approach, there is no direct link in the Council Common Position between selection priorities and legal measures. Because of the reference to 'unacceptable risk' in Article 21(1), a substance identified for action will have to undergo a risk assessment procedure relying heavily on non-environmental factors such as industry cost and competitiveness . Binding reduction measures will not necessarily follow even if a risk has been scientifically proven.

In addition, Article 21(5) states that in its proposals for the substances concerned the Commission 'shall identify the cost-effective and proportionate level and combination of product controls and emission limit values for process controls.' This marks another crucial difference between Parliament and Council concepts of the kind of measures to be taken. While the Council intends to reduce releases of hazardous substances to an acceptable risk (according to chemicals legislation), Parliament aims at the cessation of releases by 2020 (analogous to OSPAR).

Finally, even for substances deemed to pose an unacceptable risk, the Council has given itself up to seven years to adopt these measures (Article 21(6a)).

B 3.3 Chemicals legislation: Identification of risk does not lead to risk management

In general, the scope of the risk management to reduce concentrations to an acceptable risk is insufficient and in stark contrast to the OSPAR objective (cessation of discharges, emissions and losses of hazardous substances to reach the long-term aim of zero-concentrations).

The existing chemicals legislation does not even ensure the achievement of the limited aim it sets for itself. For the very limited number of substances which have undergone a full risk assessment, risk reduction recommendations did not lead to any Commission or Council measures so far. It can be justly stated that a direct link between risk assessment and risk management is absent from current EU chemicals law.

.

PART C: Synopsis of Parliament and Council Positions on the regulation of hazardous chemicals in the Water Framework Directive

 

 

European Parliament's position (first reading)

Council Common Position

Current EU chemicals legislation

Legally binding goals regarding chemical pollution

cessation of discharges, emissions and losses of hazardous substances

control of a limited number of substances posing an unacceptable risk to the environment (normally only reduction measures, not elimination)

full risk assessment following EU regulation 793/93 (has led to not one single substance to be regulated in 6 years)

Deadline to achieve goal

by 31 Dec. 2020, with specific interim goals

none

none

Target group

all hazardous substances, identified by their intrinsic properties

no overall target group, need for regulation to be proven and justified for each single substance

no overall target group, need for regulation to be proven and justified for each single substance

Selection of substances to be

acted upon

  1. establishment of a target list of all hazardous substances as defined in Art. 2
  2. substances on target list to be ranked according to their relative risk based on potential exposure and intrinsic hazard (using COMMPS as a tool to rank substances)
  3. action starting from top of list, all substances to be acted upon by 2020

 

  1. arbitrary number of 30 substances in first six years, questionable if further substances will be regulated afterwards
  2. COMMPS procedure for selection of 30 substances according to hazard and proven exposure
  3. before measures are taken, substances to undergo risk assessment (see Art. 21(1)), taking into account inter alia economic effects (Regulation (EEC) No. 793/93)

no action without full risk assessment according to Regulation (EEC) N0. 793/93,

this implies taking account inter alia of economic effects

Mechanism to enforce submission of hazard data by industry

  1. establishment of a second list of data-deficient potentially hazardous substances
  2. standard data set to be supplied by 31 December 2003, otherwise inclusion on target list and normal procedure for hazardous substances

no mechanism to enforce data submission, hence effectively an incentive for manufacturers/users not to supply such data

no mechanism to enforce data submission, hence effectively an incentive for manufacturers/users not to supply such data

Risk management (link between identification of risk and legal measures)

reliable link because of binding goal to cease releases of hazardous substances by 2020;

no reference to risk assessment

link exists, yet likely to be ineffective due to strong reference to risk assessment and without deadline

none