Annexes to COM(2013)264 - Healthier Animals and Plants and a Safer Agri-Food Chain - A modernised legal framework for a more competitive EU - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2013)264 - Healthier Animals and Plants and a Safer Agri-Food Chain - A modernised legal framework for a more competitive EU. |
|---|---|
| document | COM(2013)264  |
| date | May 6, 2013 |
Exports of plants, plant products and other objects to third countries are also covered by the proposed Regulation. Exports are governed either in accordance with the relevant EU requirements, or, if the non-EU country’s rules so allow or that country so agrees, in accordance with the requirements of that country. The proposal also provides for the introduction of a pre-export certificate, for cases where plant material is exported from a Member State which is not the Member State of origin. The pre-export certificate is meant to replace the informal guidance document currently in use.
Enhanced prevention on import and reinforced early action against outbreaks
Prevention is enhanced by empowering the Commission to adopt precautionary measures concerning new, high-risk planting material imported from non-EU countries, based on a preliminary risk assessment, for a time limit of four years. This time span is considered necessary to perform a full risk assessment and rule on the appropriateness of permanent measures. The proposed Regulation provides that when passengers bring regulated plants into the EU territory in their luggage they must now comply fully with the relevant requirements and prohibitions.
Furthermore, the proposed Regulation obliges Member States to carry out surveillance in their territory for the presence of pests in areas where they were not previously known to occur. If pests are detected, Member States will be expected to carry out eradication measures, including the demarcation of a restricted area consisting of an infested zone surrounded by a buffer zone. In addition, enhanced levels of preparedness and surveillance are required for quarantine pests identified as priority pests. Surveillance and eradication obligations will not apply to quality pests.
The proposed Regulation empowers the Commission to adopt implementing acts to contain (control) quarantine pests that cannot be eradicated from the EU territory.
Reinforcement and modernisation of the internal market provisions
Where plant material is to be moved within the EU, the proposed Regulation provides for the mandatory use of a plant passport, attesting compliance with the legislation on quarantine and quality pests. The passport, simplified and standardised under the Commission’s proposal, is to be issued by operators, under the supervision of the competent authorities. Operators will have to store the information necessary to trace infested consignments, but the passport can contain data carriers (barcodes, etc.) instead of the current lot number. Where planting material requires both, a plant passport and a certification label under EU law on plant reproductive material, the two labels can now be combined in a single document, thus reducing the administrative burden on operators. Plant passports will be required for all nursery stock, but not for sales to final non-professional users.
4.3. The Plant Reproductive Material Law
In 2007, Member States in the Council asked that the existing legislation on marketing plant reproductive material be made simpler. Following an external evaluation[3] in 2007-2008, an Action Plan[4] was adopted in 2009. The Commission’s proposal for a Regulation on the marketing of plant reproductive material (referred to here as the Plant Reproductive Material Law, builds on extensive consultations of Member States, stakeholders and the Community Plant Variety Office (CPVO).
4.3.1. Main changes
The major principles behind the revision were simplification, modernisation, cost reduction, greater efficiency and increased flexibility for operators, ensuring an appropriate level of harmonisation across the EU and horizontal coordination with other, mostly environmental EU policy objectives.
Simplification and modernisation
These objectives have been achieved by replacing the 12 directives currently dealing with specific types of plant reproductive material, such as agricultural crops, fruit plants, ornamental plants, vegetables and forest reproductive material, with one regulation. It introduces harmonised basic rules to all types of plant reproductive material (such as freedom from harmful organisms and defects) while maintaining stricter rules for important plants marketed throughout the EU, e.g. listed plant species, the varieties of which have to undergo tests for distinctness, uniformity and stability and certification and inspections for marketing. In addition, the scope of the law is extended to exports and to supply for industrial processes.
Flexibility, cost reduction and efficiency gains
The aim of significantly reducing the overall administrative burden and cost has been achieved by giving operators and competent authorities considerable freedom in completing registration and certification tasks and by introducing the principle of cost recovery for variety registration (and for certification via the Regulation on Official Controls). However, micro-enterprises will be exempted and fees could be reduced for varieties with an officially recognised description and for registration of heterogenous material, in the interest of conserving genetic resources and biodiversity.
The new legislation fosters flexibility in variety registration by allowing most registration tasks for new varieties to be performed by operators under official supervision if the operator requests this.
The current obligation to notify the Commission of a variety and include it in the Common Catalogues before marketing throughout the EU will be abolished to speed up innovation, i.e. market access for new plant varieties. Registering a plant variety in one Member State will be sufficient.
The CPVO will have a greater role in variety registration. The CPVO will manage the EU Plant Variety Database instead of the Commission and the option of registering a variety directly with the CPVO will be introduced. To ensure the quality of the registration process, national variety examination centres will be audited by the CPVO. The CPVO will also continue to harmonise testing protocols for new varieties. In addition, a ‘one-key, several doors’ approach will enable a new variety to be registered for marketing purposes and granted plant variety rights under a single procedure.
The process of certifying plant reproductive material lots before marketing will also be made more flexible. The option of certification by the operator under the official supervision of a Member State competent authority will be extended to all listed species and to all marketing categories of plant reproductive material.
Horizontal coordination with other EU policy objectives
In order to improve biodiversity and conservation of plant genetic resources on farm, the requirements for traditional and conservation varieties and other material, e.g. heterogenous and niche market material, have been considerably reduced. No variety testing and certification are required. This will considerably improve market access for such material. Traditional and conservation varieties can be registered at low cost on the basis of historical data by using a variety description recognised by the competent authority. In addition, the rules have been amended to cater for the possibility to authorise for marketing of heterogenous material (e.g. populations) and niche market material in small quantities by micro-enterprises.
Testing protocols for the agricultural sustainability criteria (e.g. for disease and drought resistance) for variety registration will be harmonised for the first time to steer plant breeding in a more sustainable direction. However, the Member States may continue to manage testing of new varieties for value for cultivation and use, based on their agro-ecological conditions.
4.4. The Regulation on Official Controls
The proposal to amend the general framework for official controls laid down in Regulation (EC) No 882/2004 incorporates the outcome of a number of evaluations which have dealt with the different aspects of that framework.
Options for revision were extensively discussed with Member States within the Working Group on the General Application of Regulation 882/2004 and at the preparatory stages of two studies (in 2009 and 2011) carried out on the state of application of the rules governing the financing of official controls. Stakeholders were consulted in the Advisory Group on Food Chain and Animal Health and Plant Health.
4.4.1. Main changes
Consolidation of the integrated approach, with sector-specific flexibility
One major novelty is the broadening of the scope of the rules on official controls, and in particular, their extension to relevant controls on plant health, plant reproductive materials and animal by-products, which until now have been governed by sectorial provisions not fully consistent with the approach laid down in Regulation (EC) No 882/2004. The current detailed set of rules applicable to official controls on residues of veterinary medicines will be repealed to allow this area to be regulated in a more risk-based, but still health-protective way, under the same legislative framework.
This revision will have a significant impact on the legal framework governing official controls on products from non-EU countries. It provides a set of common rules for all control activities to be performed at EU borders on animals and goods from non-EU countries which require increased attention for health reasons. In this context, it introduces Border Control Posts (BCPs) designed to replace the current Border Inspection Posts (BIPs — for animals and derived products), Designated Points of Entry (DPEs — for feed and food products of plant origin) and Points of Entry (plants and plant products). A uniform set of rules will apply to controls carried out at the BCPs and a Common Health Entry Document (CHED) will be used for prior notification of the arrival of consignments and to record official controls and decisions (replacing the standard documents currently in use in each sector)[5]. While documentary controls will remain systematic for all regulated goods and for animals, common criteria will ensure that identity and physical controls do not exceed what is required having regard to the risk posed by different categories of products.
Provision is made for adopting further rules for specific sectors by means of delegated and implementing acts.
More effective enforcement mechanisms
A number of changes will ensure that the toolkit offered by Regulation (EC) No 882/2004 to national enforcers is made simpler to use and more effective:
– for each of the sectors covered by the package, each Member State will be asked to designate a single authority responsible for coordinating preparation and ensuring the coherence of a multi-annual control plan and to act as a contact point for the Commission and other Member States in relation to official controls;
– electronic handling and processing of the CHED for all animals and goods subject to controls at the border will be introduced;
– while the requirement for all official laboratories to be accredited against ISO standard 17025 is reaffirmed, transitional measures and temporary or permanent derogations are provided for as appropriate.
The proposal also aims at improving the usability of the rules on ‘administrative assistance’, i.e. the mechanisms which allow cooperation between national control authorities on cross-border enforcement issues, where violations of EU rules need to be pursued not only in the Member State in which the violation was detected but also in the Member State where it originates. A new EU wide mechanism for the rapid exchange of information related to serious and widespread violations will enable Member States to address fraudulent practices more effectively.
Financing of official controls
Allocating appropriate resources to official controls is essential to prevent major disruptions to the EU’s system of official controls in the agri-food chain and to guarantee its capacity to anticipate and respond to health emergencies as effectively as possible.
The proposal builds on the current system of mandatory fees (at present only charged to certain operators and/or for certain controls). It strengthens the principle according to which competent authorities should be able to charge businesses in order to recover the costs they incur in carrying out their official control duties along the agri-food chain and in certain related areas (e.g. veterinary and phytosanitary controls, controls on plant reproductive material).
A number of improvements to the current set of rules are proposed with a view to ensuring a consistent and steady stream of resources to the competent authorities and to eliminating the known shortcomings of the existing system:
– mandatory fees will be charged to all registered food and feed businesses and to operators in the plant and plant reproductive material sectors so as to spread the cost of controls across the entire chain;
– fees will enable the competent authorities to fully recover the costs incurred, so as to make their revenues less dependent on national budgetary policies and reduce the risk of under-resourcing as a result of funds being reallocated to competing priorities;
– more equity and fairness will be achieved by ensuring that the methods used to calculate the fees and the list of costs covered are fully transparent, and by requiring Member States to reward consistent compliance by operators (e.g. with reduced fee rates);
– as a rule, micro-enterprises will be exempted from the payment of the fees.
4.5. Management of expenditure
The main objective of the Commission’s proposal on management of expenditure is to accompany proposed changes in the relevant policy areas and to seek alignment with the EU’s Multiannual Financial Framework, while allowing the use of reserves in the agricultural sector under certain circumstances, for example in response to crises.
Regarding plant health, in order to protect the EU against the introduction and spread of pests, survey programmes for the presence of pests will be funded as well as phytosanitary support measures for the outermost regions of Member States. The new framework will also allow funding of initiatives designed to update legislation in order to keep up with technological and scientific development and to ensure efficient and effective enforcement. In case of emergency measures, Union co-financing will be possible as of the entry into force of the Plant Health Law for compensation to growers for the lost value of plant material subject to destruction.
5. Conclusion
The proposed legislative package is the result of a major revision of the most relevant components of EU legislation governing the production and placing on the market of food, the safety of the food and feed chain, and the health of plants and animals.
The revision in question has involved experts from the Member States, and all concerned stakeholders, since 2004 in the case of the animal health legislation and for more than three years in the other areas. It was carried out to assess the fitness for purpose of the vast range of rules which the EU has produced over time to deliver the Treaty objectives of ensuring a high level of health for humans, animals and plants during the various processes along the path from farm to fork (from primary production to the consumption and disposal of food). Production methods and techniques have changed, globalisation and increased exchanges are having an impact on the spread of hazards and risks, new hazards and risks have arisen, and consumers’ expectations and education have evolved with all that.
This comprehensive revision has resulted in the proposed changes to the animal health legislation, to the legislation governing plant health and plant reproductive material and to the rules on official controls and other official activities along the agri-food chain. These changes aim to deliver a more effective and modern legal framework for those issues, to increase the flexibility and proportionality of rules established in some cases more than 40 years ago and, overall, to better meet the needs of citizens and businesses.
[1] http://ec.europa.eu/food/animal/diseases/strategy/index_en.htm.
[2] COM(2008) 545 final, http://ec.europa.eu/food/animal/diseases/strategy/documents_en.htm.
[3] FCEC (2008), Evaluation of the Community acquis on the marketing of seed and plant propagating material (S&PM). Final Report.
[4] SEC(2009) 1272 final.
[5] I.e. the Common Veterinary Entry Document (CVED) in the area of veterinary controls, the Common Entry Document (CED) for non-veterinary controls, and the phytosanitary certificate currently in use in the plant health sector.