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Kommissionen vedtager meddelelse om forsigtighedsprincippet

Commission Européenne - IP/00/96   02/02/2000

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IP/00/96

Bruxelles, den 2. februar 2000

Kommissionen vedtager meddelelse om forsigtighedsprincippet

Europa-Kommissionen har i dag vedtaget en meddelelse om brugen af forsigtighedsprincippet. Formålet med meddelelsen er at oplyse alle interesserede parter om, hvordan Kommissionen har til hensigt at anvende princippet og fastlægge retningslinjer for anvendelsen heraf. Formålet er også at give et input til den løbende debat af dette emne både på EU-plan og internationalt plan. I meddelelsen understreges det, at forsigtighedsprincippet er en del af en struktureret strategi for risikoanalyse, og at det er relevant for risikostyring. Det dækker tilfælde, hvor de videnskabelige beviser er utilstrækkelige, ufyldestgørende eller usikre, og den foreløbige videnskabelige vurdering tyder på, at der er grund til at formode, at de mulige skader på miljøet samt på mennesker, dyr og planters sundhed ikke stemmer overens med det høje beskyttelsesniveau, som EU har valgt. Dagens meddelelse supplerer hvidbogen om fødevaresikkerhed, som blev vedtaget for nylig, og den aftale om Cartagena-protokollen om biosikkerhed, som blev indgået i Montreal i weekenden.

I meddelelsen beskrives også de forholdsregler, som kan træffes ifølge forsigtighedsprincippet. Når man finder, at indgreb er nødvendige, skal foranstaltningerne være proportionale med det valgte beskyttelsesniveau, kunne anvendes ikke-diskriminerende og stemme overens med lignende allerede trufne foranstaltninger. De skal også baseres på en undersøgelse af potentielle fordele og omkostninger ved at gribe ind eller ikke at gribe ind og revideres i lyset af nye videnskabelige data, og skal altså opretholdes, så længe de videnskabelige data er utilstrækkelige, unøjagtige eller foreløbige, og så længe risikoen formodes at være så høj, at samfundet ikke bør udsættes for den. Sluttelig skal de gøre det muligt at tillægge ansvar - eller bevisbyrde - i forbindelse med frembringelse af de videnskabelige resultater, der er nødvendige for en omfattende risikovurdering. Disse retningslinjer beskytter mod uhensigtsmæssig anvendelse af forsigtighedsprincippet som en skjult form for protektionisme.

Dagens meddelelse blev forelagt Kommissionen af kommissær for erhvervspolitik og informationssamfundet, Erkki Liikanen, kommissær for sundhed og forbrugerbeskyttelse, David Byrne, og miljøkommissær, Margot Wallström. Det er en opfølgning på Kommissionens formand, Romano Prodis tale til Europa-Parlamentet den 5. oktober 1999.

I meddelelsen erindres der om, at et antal tilfælde af nyere dato har undergravet offentlighedens og forbrugernes tillid, fordi de beslutninger, som blev truffet eller ikke blev truffet, ikke blev støttet af fyldestgørende videnskabelige beviser, og lovligheden af sådanne beslutninger var tvivlsom.

Kommissionen har til stadighed tilstræbt at opnå et højt beskyttelsesniveau, blandt andet med hensyn til miljøets, menneskenes, dyrenes og planternes sundhed. Det er Kommissionens politik at træffe beslutninger med henblik på at opnå et højt beskyttelsesniveau på et godt og tilstrækkeligt videnskabeligt grundlag. Når der er grund til at formode, at mulige farer kan påvirke miljøet samt menneskers, dyrs og planters sundhed, og når på samme tid manglen på videnskabelige oplysninger udelukker en detaljeret videnskabelig evaluering, har forsigtighedsprincippet dog været den politisk accepterede strategi for risikostyring på adskillige områder. Selv om forsigtighedsprincippet kun eksplicit nævnes i EF-traktaten inden for miljøområdet, mener Kommissionen, at dette princips anvendelsesområde er langt større end miljøområdet, og at det også dækker beskyttelsen af menneskers, dyrs og planters sundhed.

I meddelelsen gøres det klart, at forsigtighedsprincippet hverken er en politisering af videnskaben eller en accept af begrebet "nulrisiko", men at det giver et grundlag for indgreb, når videnskaben ikke kan give et klart svar. I meddelelsen gøres det også klart, at fastlæggelsen af, hvad der er et acceptabelt risikoniveau i EU, er et politisk spørgsmål. Den giver en begrundet og struktureret ramme for indgreb i tilfælde af videnskabelig usikkerhed og viser, at forsigtighedsprincippet ikke retfærdiggør, at man ignorerer videnskabelige beviser og træffer protektionistiske beslutninger.

De horisontale retningslinjer, som er fastlagt i denne meddelelse, vil i fremtiden være et nyttigt grundlag for at træffe politiske beslutninger på dette område og bidrage til, at der træffes lovlige beslutninger, når videnskaben ikke er i stand at vurdere risikoen på fyldestgørende vis, i stedet for beslutninger, som er baseret på en irrationel angst eller opfattelse. Det er således et af formålene med meddelelsen at give en klar beskrivelse af de situationer, hvor forsigtighedsprincippet kan anvendes, og fastlægge omfanget af de foranstaltninger, der træffes i denne sammenhæng. Den vil derfor bidrage til at sikre et velfungerende indre marked, og at der findes en høj grad af beskyttelse og forudsigelighed for forbrugerne og økonomiske beslutningstagere i og uden for EU.

Annex

COMMUNICATION FROM THE COMMISSION

on the precautionary principle

SUMMARY

    The issue of when and how to use the precautionary principle, both within the European Union and internationally, is giving rise to much debate, and to mixed, and sometimes contradictory views. Thus, decision-makers are constantly faced with the dilemma of balancing the freedom and rights of individuals, industry and organisations with the need to reduce the risk of adverse effects to the environment, human, animal or plant health. Therefore, finding the correct balance so that the proportionate, non-discriminatory, transparent and coherent actions can be taken, requires a structured decision-making process with detailed scientific and other objective information.

    The Communication's fourfold aim is to:

    • outline the Commission's approach to using the precautionary principle,

    • establish Commission guidelines for applying it,

    • build a common understanding of how to assess, appraise, manage and communicate risks that science is not yet able to evaluate fully, and

    • avoid unwarranted recourse to the precautionary principle, as a disguised form of protectionism.

    • It also seeks to provide an input to the ongoing debate on this issue, both within the Community and internationally.

    3.  The precautionary principle is not defined in the Treaty, which prescribes it only once - to protect the environment. But in practice, its scope is much wider, and specifically where preliminary objective scientific evaluation, indicates that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of protection chosen for the Community.

      The Commission considers that the Community, like other WTO members, has the right to establish the level of protection - particularly of the environment, human, animal and plant health, - that it deems appropriate. Applying the precautionary principle is a key tenet of its policy, and the choices it makes to this end will continue to affect the views it defends internationally, on how this principle should be applied.

      4.  The precautionary principle should be considered within a structured approach to the analysis of risk which comprises three elements: risk assessment, risk management, risk communication. The precautionary principle is particularly relevant to the management of risk.

      The precautionary principle, which is essentially used by decision-makers in the management of risk, should not be confused with the element of caution that scientists apply in their assessment of scientific data.

      Recourse to the precautionary principle presupposes that potentially dangerous effects deriving from a phenomenon, product or process have been identified, and that scientific evaluation does not allow the risk to be determined with sufficient certainty.

      The implementation of an approach based on the precautionary principle should start with a scientific evaluation, as complete as possible, and where possible, identifying at each stage the degree of scientific uncertainty.

      5.  Decision-makers need to be aware of the degree of uncertainty attached to the results of the evaluation of the available scientific information. Judging what is an "acceptable" level of risk for society is an eminently political responsibility. Decision-makers faced with an unacceptable risk, scientific uncertainty and public concerns have a duty to find answers. Therefore, all these factors have to be taken into consideration.

      In some cases, the right answer may be not to act or at least not to introduce a binding legal measure. A wide range of initiatives is available in the case of action, going from a legally binding measure to a research project or a recommendation.

      The decision-making procedure should be transparent and should involve as early as possible and to the extent reasonably possible all interested parties.

      6.  Where action is deemed necessary, measures based on the precautionary principle should be, inter alia:

      • proportional to the chosen level of protection,

      • non-discriminatory in their application,

      • consistent with similar measures already taken,

      • based on an examination of the potential benefits and costs of action or lack of action (including, where appropriate and feasible, an economic cost/benefit analysis),

      • subject to review, in the light of new scientific data, and

      • capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment.

      Proportionality means tailoring measures to the chosen level of protection. Risk can rarely be reduced to zero, but incomplete risk assessments may greatly reduce the range of options open to risk managers. A total ban may not be a proportional response to a potential risk in all cases. However, in certain cases, it is the sole possible response to a given risk.

      Non-discrimination means that comparable situations should not be treated differently, and that different situations should not be treated in the same way, unless there are objective grounds for doing so.

      Consistency means that measures should be of comparable scope and nature to those already taken in equivalent areas in which all scientific data are available.

      Examining costs and benefits entails comparing the overall cost to the Community of action and lack of action, in both the short and long term. This is not simply an economic cost-benefit analysis: its scope is much broader, and includes non-economic considerations, such as the efficacy of possible options and their acceptability to the public. In the conduct of such an examination, account should be taken of the general principle and the case law of the Court that the protection of health takes precedence over economic considerations.

      Subject to review in the light of new scientific data, means measures based on the precautionary principle should be maintained so long as scientific information is incomplete or inconclusive, and the risk is still considered too high to be imposed on society, in view of chosen level of protection. Measures should be periodically reviewed in the light of scientific progress, and amended as necessary.

      Assigning responsibility for producing scientific evidence is already a common consequence of these measures. Countries that impose a prior approval (marketing authorisation) requirement on products that they deem dangerous a priori reverse the burden of proving injury, by treating them as dangerous unless and until businesses do the scientific work necessary to demonstrate that they are safe.

      Where there is no prior authorisation procedure, it may be up to the user or to public authorities to demonstrate the nature of a danger and the level of risk of a product or process. In such cases, a specific precautionary measure might be taken to place the burden of proof upon the producer, manufacturer or importer, but this cannot be made a general rule.


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