Explanatory Memorandum to COM(2005)362-1 - Animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals - Main contents
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| dossier | COM(2005)362-1 - Animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain ... |
|---|---|
| source | COM(2005)362  |
| date | 23-08-2005 |
Grounds for and objectives of the proposal
The purpose of this proposal is to update, recast and consolidate the animal health rules in relation to the trade in aquaculture products, including disease prevention and control, in order to improve the competitiveness of EU aquaculture producers.
Aquaculture is a very important industry in the Community, particularly in rural and coastal areas. In 2004, EU aquaculture produced fish, molluscs and crustaceans worth more than €2,5 billion. However, financial losses due to disease (mortalities, reduced growth and reduced quality) are estimated to be 20 % of the production value. The proposal aims to introduce modern and targeted legislation that reduces these costs; if they could be reduced by only 20%, the result would be an added value of €100 million per year.
The existing legislation was developed two decades ago when the EU had only 12 Member States. It was primarily designed to protect the main EU aquaculture at that time, namely salmonid (trout and salmon) and oyster farming. The legislation now needs to be updated to reflect the broader range of aquaculture practises and species that are found in the expanded EU, and to take account of the significant developments within the industry, the experience gained through 15 years of application of the existing legislation, as well as scientific advances in this field. The rules must also be updated to bring EU rules in line with international agreements and standards (like WTO/SPS and OIE).
This proposal corresponds to the Commission legislative Working Programme project 2004/SANCO/0025
General context
This proposal will repeal the existing primary legislation (Council Directives 91/67/EEC, 93/53/EEC and 95/70/EC) and replace those three Directives with one new Directive. This much needed revision and consolidation will update the legislation to reflect the EU aquaculture industry in the 21st century, and simplify and modernise existing rules to provide more flexibility, and delegate more operational responsibility to Member States so that, for example, effective local or regional approaches can be taken to prevent and contain diseases.
Existing provisions in the area covered by the proposal
- Council Directive 91/67/EEC of 28 January 1991 concerning the animal health conditions governing the placing on the market of aquaculture animals and products;
- Council Directive 93/53/EEC of 24 June 1993 introducing minimum Community measures for the control of certain fish diseases;
- Council Directive 95/70/EC of 22 December 1995 introducing minimum Community measures for the control of certain diseases affecting bivalve molluscs.
The general principles laid down in the three Directives in question will be maintained.
In addition, there are 13 implementing Decisions which have been adopted pursuant to those Directives. The implementing Decisions will remain in force until they are repealed by a specific Decision, or replaced by a Decision adopted pursuant to this proposal.
Consistency with other policies
The aquaculture industry falls under the Common Fisheries Policy (CFP). The main interaction between this proposal and the legislation related to the CFP concerns the financial support (see also Com (2004) 497 - final). It is proposed that the same principle applied for terrestrial animal diseases, namely that a financial contributions from the Community should be made available where Community law requires a slaughter/eradication policy to be carried out, should also be applied to aquatic animal diseases.
The proposal upholds the principle laid down in existing legislation that the animal health provisions shall apply without prejudice to national or international provisions on the conservation of species or the introduction of non-native species. More stringent rules may therefore be applied where this is necessary for the protection of species from an environmental or conservation point of view. The proposal would therefore not conflict with Council Directive 92/43/EEC on the conservation of natural habitats and of wild fauna and flora. Furthermore, major change in policy to concentrate more on, - allowing Member States to allocate more resources to - disease prevention, should reduce the environmental impact of the aquaculture industry by reducing outbreaks of disease.
Public health concerns are not dealt with in this proposal, as it is regulated by the 'hygiene package'. None of the diseases or pathogens covered by this proposal is known to have zoonotic potential.
The welfare of farmed fish falls within the scope of the existing general provisions of Community legislation concerning the protection of animals kept for farming purposes. Scientific advice from the European Food Safety Authority, in addition to Council of Europe recommendations concerning the welfare of fish (within the scope of the European Convention for the protection of animals kept for farming purposes) will influence future policy initiatives in this area.
The present animal health provisions relating to third countries will in principle remain unchanged.
Consultation of interested parties
Consultation methods, main sectors targeted and general profile of respondents.
Written consultations took place in 2000 and 2001 via the Advisory Committee on Fisheries and Aquaculture (ACFA). In this Committee the following organisations are represented: Federation of European Aquaculture Producers (FEAP), European Mollusc Producers Association (EMPA/AEPM), Comité des Organisations Professionnelles Agricoles de l'UE (COPA/COGECA), Organisation of the workers unions (ETF), NGO for consumer and NGO for environment. The Commission’s services have regularly reported on developments in the project in the ACFA Working Group 2 (Aquaculture).
Bilateral meetings have been held with FEAP and EMPA/AEPM during 2003, 2004 and 2005.
Stakeholder consultations were held in September and December 2004. There have been several technical working group meetings with representatives from the Member States and EFTA/EEA states.
Summary of responses and how they have been taken into account.
The main comments from the Member States and stakeholders have been taken into account in the framing of the proposal.
For the stakeholders, it is essential that the Directive contains a mechanism that will enable farms to maintain and, where possible improve, their health status, and also to encourage farms to make their health status known as a means of facilitating safe trade. An appropriate categorisation of health status will be the only way to prevent a degradation of the aquatic animal health status in the Community. The concept of categorisation has been introduced in the proposal.
The aquaculture industry's need for economic compensation for disease eradication and control measures is also of importance to stakeholders, and is acknowledged by the Commission and the Member States. This acknowledgement is further discussed in a proposal for a Council Regulation - European Fisheries Fund (COM(2004) 497).
Where the requests from the stakeholders have not been taken into account, it has been due to the international commitments of the Community or due to the need for cross-compliance with other Community legislation, in particular the WTO/SPS agreement and the EU Food Law.
Collection and use of expertise
Scientific/expertise domains concerned.
Aquatic animal health.
Methodology used.
Main organisations/experts consulted.
The scientific platform for the proposal was established by a working group of experts on aquatic animal health from EU and EFTA/EEA Member States. In addition experts from the industry were consulted.
Level of scientific certainty: high.
Advice received and used.
Means used to make the expert advice publicly available.
Advice from expert working group meetings and stakeholder consultation meetings has not been made publicly available. However, the advice has been discussed with competent authorities and stakeholders in meetings.
Impact assessment
The main provisions for placing on the market an import remains largely unchanged. However, some existing trade barriers have been removed without jeopardising the health status of aquaculture animals. The general disease control provisions will remain unchanged, with some minor adjustments. All diseases considered exotic to the Community will be subject to eradication provisions in order to maintain the Community’s free status. Under the present legislation such measures are applied for fish disease but not for mollusc diseases. The importation provisions are harmonised with the relevant provisions of Council Directive 2002/99/EC (the most recent Directive laying down animal health import provisions).
Positive impacts will arise from an updated Community legislative framework which takes into account current scientific knowledge and the structure of today's aquaculture industry in the Community.
There will be positive shift in focus away from preventing the spread disease and towards the occurrence of disease. Significant resources are now being used to maintain disease-free status in farms and zones that have been declared disease-free. The proposal would allow the Member State to re-allocate some of these resources to disease preventive activities.
The proposal implements the philosophy that the best solution is often found closest to the problem, and delegates more operational responsibility to the Member States.
By introducing general risk-based animal health surveillance, a better overview of the disease situation can be achieved. At the same time the risk of spreading diseases to farms or areas where the disease has not yet been found is reduced.
The proposal takes into account the potential for exchange of disease agents between farmed and wild aquatic animals.
The new legislation will be consistent with the International Aquatic Animal Health Code of the World Organisation for Animal Health (OIE), and will reduce existing trade barriers between third countries, including developing countries, and the Community.
The negative impact will be limited, as the proposal will to a large extent be founded on the existing legislation. Some new elements and requirements will have an administrative and economic impact on the Member States and on the industry.
The proposal for authorisation of aquaculture production business will cause extra work for the competent authorities in the Member States. However, since all mollusc farms and the majority of fish farms are already registered, the authorisation requirement is achievable for the Member States.
The introduction of a general risk-based animal health surveillance in all farms or farming areas, is an extension of the requirements in the present mollusc legislation, under which all Member States must have a monitoring and sampling program.
Contents
- LEGAL ELEMENTS OF THE PROPOSAL
- This proposal corresponds to the Commission legislative Working Programme project 2004/SANCO/0025
- This proposal will replace
- 2. CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT
- The opinions have been considered in the draft proposal
- Yes
- Positive impacts
- Negative impacts
- The proposal includes
- Article 37 of the Treaty
- 4. BUDGET IMPLICATIONS
- 5. ADDITIONAL INFORMATION
Summary of the proposed action
- General requirements directed towards the aquaculture production business and processing establishments, such as authorisations, and provisions related to their operation;
- Animal health provisions for placing on the market of aquaculture animals and products thereof;
- Animal health provisions for introduction of aquaculture animals into the Community from third countries;
- Provisions for notification and control of certain diseases in aquatic animal;
- Provisions for declaration of disease-free status;
- Requirements directed towards the competent authorities of the Member States, and laboratories;
- Technical requirements and guidelines laid down in Annexes.
Legal basis
Subsidiarity principle
The proposal falls within the exclusive competence of the Community. The subsidiarity principle therefore does not apply.
Proportionality principle
The proposal complies with the proportionality principle for the following reason(s).
For the sake of the completion of the internal market, the animal health provisions applicable to the placing on the market of aquaculture animals should be fully harmonised.
Some of the diseases subject to harmonised trade provisions are widespread in parts of the Community. It is however not realistic to enforce the same level of control measures in Member States that are free of these diseases, as in Member States where these diseases are widespread.
The introduction of the principle of compartmentalisation will allow for more flexibility.
The administrative and economic burden imposed will result in a higher health status, reduction of losses due to diseases and more open trade. Increased financial burden on the Community budget will be limited to the financial contribution in relation to the control and eradication of diseases which are subject to compulsory eradication measures.
Choice of instruments
Proposed instruments: Directive.
Other means would not be adequate for the following reason(s).
Experience since 1964 with harmonised veterinary legislation in the Community, and in particular since 1991 with specific aquatic animal health legislation, have shown that a Directive gives sufficient flexibility for the Member States to apply Community veterinary legislation in the framework of national legislation and administration.
The economic impact on Community budget is expected to be limited, and will mainly be in two areas:
(a) Economic compensation in relation to disease control.
The proposal should not affect the future development of the Community policy on animal health and the veterinary fund.
Council Decision 90/424/EEC on expenditure in the veterinary field already allows for financial support in relation to outbreaks of Infectious Haematopoietic Necrosis (IHN) and Infectious Salmon Anaemia (ISA), under Regulation (EC) No 2792/1999 solely.
It is proposed that financial contribution for aquatic animal disease control from the Community should be eligible through the European Fisheries Fund (Article 32 of COM (2004) 497).
In the proposal, compulsory slaughter/eradication will only be required under Community rules in relation to outbreaks of diseases that are considered exotic to the Community. With respect to non-exotic diseases it is proposed that the Member States may decide whether an outbreak should be subject to eradication measures or containment measures. Community funding under European Fisheries Fund may be made available for control measures of such diseases if the Member State so decides.
If an exotic disease did occur in the Community, it would have no financial impact on Community budget. The same would occur in case of compensation for eradication of non-exotic diseases, since the allocation of funds for the eradication are made within the Operational Programmes, whose budget is fixed by the Council at the beginning of the programming period.
In the interest of Member States, it would be convenient to assess the financial impact of eradication on their Operational Programmes. However, the costs related to such eradication measures are difficult to estimate, as there is limited experience in the Community of stamping out policy involving economic compensation in aquaculture. In the court case following the outbreaks of ISA in the UK and Ireland, one company owning five of the thirteen infected farms claimed total losses in the region of € 20-25 million. Sweden paid out compensation under national legislation totalling of 1,5 mill SEK (€165 000) over a period of three years in relation to four cases of VHS in 1998.
It is therefore difficult to estimate the impact of the proposal on the European Fisheries Fund, as this will depend on the size of the farm(s) affected, the value of the animals kept at the farm(s), etc. However, the figures above can give an indication.
(b) Implementation of primary legislation and adoption and management of secondary legislation
Once the Council has adopted the proposal, it will be necessary to draw up, adopt and maintain secondary legislation. It will be necessary to arrange a number of working group meetings with Member States and stakeholders, the latter normally without any additional cost for the Community budget. The number of working groups is impossible to determine, as this will depend on the complexity of the items, and the views of the Member States.
After the act’s entry into force, FVO inspections of Member States' implementation will be necessary in 2008 and 2009 (13 or 14 inspections per year). Such inspections should as far as possible be combined with public health inspections for 'fishery products' and 'live bivalve mollusc' pursuant to Article 11 of Regulation (EC) No 854/2004. It should be possible to reduce the number of missions in subsequent years.
Simplification
The proposal provides for simplification of legislation, simplification of administrative procedures for public authorities (EU or national).
Three directives will be merged into one.
Most of the current provisions in Council Directive 93/53/ECC on the control of fish diseases are duplicated in Council Directive 95/70/EC on the control of mollusc diseases.
Delegating the power to declare individual compartments and zones free of disease to the Member States will lead to a simplification of administrative procedures in the Member States and in the Commission services.
Repeal of existing legislation
The adoption of the proposal will lead to the repeal of the three existing Directives.
European Economic Area
The proposed act is of EEA relevance and should therefore be extended to the EEA.