G/SPS/GEN/1252  
 
14 June 2013  
(13-3099)  Page: 1/5  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
HEALTHIER ANIMALS AND PLANTS AND A SAFER AGRI-FOOD CHAIN 
A MODERNISED LEGAL FRAMEWORK FOR A MORE COMPETITIVE EUROPEAN UNION 
COMMUNICATION FROM THE EUROPEAN UNION 
The following communication, received on 13 June 2013, is being circulated at the request of the 
Delegation of the European Union. 
 
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  Following the information found in notification s G/SPS/N/EU/43, G/SPS/N/EU/44, G/SPS/N/EU/45 
and G/SPS/N/EU/46 of 17 and 21 May 2013, the Eu ropean Union would like to provide all WTO 
Members with further information on the four important legislative proposals contained therein: the so-called "smarter rules for safer food" packag e. These deal respectively with animal health, 
plant health, plant reproductive material and official controls. 
1  INTRODUCTION 1.1.  Ensuring a high level of health for humans, animals and plants is one of the objectives 
enshrined in the EU founding treaties. Over time, the European Union has built up a 
comprehensive body of law designed to prevent an d manage risks to animal and plant health and 
the safety of the food chain. This legislative framework has proven, overall, to be effective in both preventing and countering risks. 
1.2.  However, the global market increasingly exposes the European Union to new challenges. New 
diseases and pests appear, production methods an d techniques radically change, globalisation and 
increased exchanges have an impact on the spread  of hazards and risks and last, but by no means 
least, consumers' expectations related to their food and the environment are steadily growing. 
1.3.  Simplification, modernisation, consistency and convergence with international 
standards  – these are the major driving principles of  the proposed pieces of legislation. By 
revising the legislative framework currently in place, the European Union aims at increasing 
effectiveness, consistency and legal clarity; providing greater certainty and predictability, and ultimately, ensuring that measures are risk-based in order to better meet the needs of citizens and 
businesses in an ever-changing environment. The idea is to better foster productivity in the 
EU agri-food sector, to ensure the smooth function ing and accessibility of the EU market and to 
reinforce its competitiveness on a global scale. 
1.4.  The proposed package aims to consolidate, an d in so doing, to also cut back the current EU 
legislative framework in this area – consisting of almost 70 pieces of legislation – to only four 
basic, science and risk-based rules concerning: 
 animal health requirements: the Animal He alth Law – notified under G/SPS/N/EU/45; 
 protective measures against pests of plants: the Plant Health Law – notified under 
G/SPS/N/EU/44; 
 rules governing the production and placing on the market of plant reproductive material: 
the Plant Reproductive Material Law – notified under G/SPS/N/EU/46;  G/SPS/GEN/1252 
 
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   rules governing official controls and other official activities performed to ensure compliance 
with the entire set of agri-food chain rules: th e Regulation on Official Controls – notified 
under G/SPS/N/EU/43. 
1.5.  The last two proposals have also been notified under the WTO Agreement on Technical 
Barriers to Trade. 
1.6.  Trading partners are invited to carefully study these important legislative proposals which 
complement the existing EU framework for ensuring a safe agri-food chain. Partners are invited to 
submit comments during the extended comment period of 120 days. These comments will be 
carefully considered by the European Union and integrated, where relevant, into the legislative framework. 
2  THE CONTENT OF THE PROPOSALS 
2.1  The Animal Health Law (G/SPS/N/EU/45) 
2.1.  The proposed legislation seeks to help auth orities and operators direct their resources where 
they are most needed in order to prevent and control animal disease.  
2.1.1  Simplification 
2.2.  The legislation seeks to reduce the administrative burden  by introducing a more coherent 
framework for the prevention and control of animal diseases, including for vaccination – 
simplifying requirements where possible. The new legislation will also clarify the animal health 
responsibilities  of operators, veterinarians, competent authorities and others. Detailed provisions 
– such as specific disease control measures, identification and registration rules for certain species and specific measures on intra-EU movement for particular species – are to be dealt with by 
means of implementing legislation (still to be developed) allowing more flexibility and speed in the 
legislative process to react to rapidly changing  scenarios and/or emergencies. The proposed 
regulation also encourages the use of new technologies  for animal health activities such as 
monitoring pathogens, electronic identification  and registration of animals and electronic 
certification. 
2.1.2  Increased flexibility through the use of a risk-based approach 
2.3.  Criteria for listing animal diseases  will be introduced on a scientific and evidential basis 
and will be systematically categorised. This will allow the European Union to better focus on the main and most dangerous diseases, according lower priority to those diseases which pose less risk. Wider use of " compartmentalisation " will be permitted (i.e. where some farms are considered 
safe even during disease outbreaks), allowing a more risk-based approach to animal disease 
control and potentially fewer trade restrictions. 
2.1.3  Imports and exports 
2.4.  Broad convergence with OIE standards  will be sought whilst ensuring a firm commitment 
to high standards of animal health in the European Union. This is expected to significantly reduce the risk of trade disruption. No practical change s in the current framework – which functions well – 
are envisaged for imports into the European Union. This is particularly the case regarding the 
requirements for third countries sending animals, germinal products, products of animal origin and other materials that could transmit animal diseases into the EU territory. 
2.2  The Plant Health Law (G/SPS/N/EU/44) 
2.5.  The proposed legislation covers all organisms directly harmful to plants, i.e. insects, mites, 
nematodes, pathogenic micro-organisms and parasitic plants (now called pests). It covers both quarantine pests  and quality pests . Criteria for deciding on the appropriate assignment of pests 
are provided in the Annexes that set out prin ciples and measures for the management of 
phytosanitary risks. G/SPS/GEN/1252 
 
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  2.6.  The geographical scope of the Plant Health Law is limited to the territories of the EU 
member States , excluding overseas countries and territories and also outermost regions, where 
certain pests against which the European Union needs to be protected are indigenous. 
2.2.1  Reinforced early action against outbreaks 
2.7.  The proposed legislation obliges EU member States to carry out surveillance  in their 
territory for the presence of pests in areas wher e they were not previously known to occur. If 
pests are detected, EU member States will be expected to carry out eradication measures, 
including the demarcation of a restricted area(s) 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. Implementing acts – which provide clear guidance on how the legislation is 
to be put into practice – may be adopted at a later date to cover (control) quarantine pests that 
cannot be eradicated from the EU territory. 
2.2.2  Reinforcement and modernisation of the internal market provisions 
2.8.  Where plant material is to be moved within the European Union, the proposed regulation 
provides for the mandatory use of a plant passport , attesting compliance with the legislation on 
quarantine and quality pests. The simplified and standardised passport 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 also contain data carriers (barcodes, etc.) instead of the current lot number. Where planting materials require a 
plant passport and also a certification label under EU law on plant reproductive material, the two 
labels can now be combined in a single document, reducing the administrative burden on 
operators. Plant passports will be required for all nursery stock, but not for sale to non-professional, final users.  
2.2.3  Imports and exports 
2.9.  Precautionary measures are foreseen for new, high-risk planting material imported into 
the European Unio n, based on a preliminary risk assessment, for up to a maximum period of 
four years. During this time a full risk assessment shall be performed and the appropriateness of 
permanent measures assessed. Insofar as passengers bring regulated plants into the 
EU territory in their luggage , they must now fully comply with the relevant requirements and 
prohibitions. 
2.10.  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 third country's rules so allow, 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 an EU member State which is not the country of origin. The pre-export certificate is meant to replace the informal guidance document currently in use. 
2.3  The Plant Reproductive Material Law (G/SPS/N/EU/46) 
2.11.  The proposed regulation deals with specific types of plant reproductive material, such as 
agricultural crops, fruit plants, ornamental plants , vegetables and forest reproductive material. It 
replaces 12 existing Directives and seeks to fulfil the over-riding aim to conserve genetic 
resources and biodiversity  and to take into account the challenges of climate change and of 
particular forms of farming such as organic production. The objective of the legislation is to continue to supply farmers and breeders with high quality and healthy material. In order to take 
into account the needs of producers, the regulation will not apply to plant reproductive material 
intended for testing and scientific purposes and intending for breeding (selection) purposes. In addition, it will not apply to material intended to or maintained in gene banks, organisations and 
networks of ex-situ  and in-situ  or on farm conservation of genetic resources. Furthermore, plant 
reproductive material exchanged in kind between two persons other than professional operators is excluded from the scope of the regulation. G/SPS/GEN/1252 
 
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  2.3.1  Simplification and modernisation 
2.12.  The proposed legislation introduces harmonised and simplified basic rules  applicable to 
all types of plant reproductive material (such as freedom from harmful organisms and defects) while maintaining stricter rules for key plants marketed throughout the European Union (i.e. listed 
plant species which have to undergo tests for distinctness, uniformity and stability).  
2.13.  Operators and competent authorities are given considerable freedom in completing 
registration and certification tasks. The principle of cost recovery  for variety registration (and 
for certification via the Regulation on Official Controls) is introduced. The current obligation to 
notify a variety and include it in the Common Catalogues before marketing it throughout the European Union will be abolished to speed up innovation. Registering a plant variety in one EU member State will, as a result of the new rules,  become sufficient. The Community Plant Variety 
Office (CPVO) will have a greater role in variety registration, managing the EU Plant Variety 
Database and the option of registering a variet y directly with the CPVO. The CPVO will also 
continue to harmonise testing protocols for new varieties and carry out audits to ensure high levels 
of quality in the registration process. 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. 
2.14.  The process of certifying plant reproductive material  lots before marketing will also be 
made more flexible. Certification by the operator  under the official supervision of the competent 
authority will be extended to all listed species and marketing categories of plant reproductive material. 
2.3.2  Horizontal coordination with other EU policy objectives 
2.15.  The requirements for traditional and conservation varieties  and other material have 
been considerably reduced. No variety testing and certification is required which will considerably 
improve market access. In addition, the rules have  been amended to cater for the possibility to 
authorise for marketing less homogenous material  (e.g. populations). Testing protocols for the 
agricultural sustainability criteria (e.g. disease and drought resistance) for variety registration will 
be harmonised for the first time while EU member States may continue to manage testing of new 
varieties for value for cultivation and use, based on their agro-ecological conditions. 
2.3.3  Imports and exports 2.16.  The EU equivalence system will be maintained as a basic condition for imports  from third 
countries while exports  shall take place in line with the legal or administrative procedures in place 
in importing countries. Where a bilateral or mult ilateral agreement between the European Union 
and the third country exists, export from the European Union shall comply with the agreement. In 
its absence, an agreement conducted between the professional operators shall apply. 
2.4  The Regulation on Official Controls (G/SPS/N/EU/43) 2.17.  By virtue of the new regulation, official controls, currently governed by Regulation (EC) 
No 882/2004, will be extended to controls on plant health, plant reproductive material and animal 
by-products which have until now been governed by sector-specific provisions. The current set of rules applicable to controls on residues of veterinary medicines will be repealed to allow this area to be regulated in a more risk-based manner, with a view to protect health, under the same 
legislative framework. 
2.4.1  More effective enforcement mechanisms 2.18.  The toolkit  offered to national enforcers is simplified and will be more effective . For 
each of the sectors covered by the "revision package", EU member States will be asked to 
designate a single authority responsible for: 
• coordinating and ensuring the coherence of a multi-annual control plan and to act as a 
contact point in relation to official controls; G/SPS/GEN/1252 
 
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  • the electronic handling and processing of Common Health Entry Documents for all animals 
and goods subject to controls at the EU border which will be introduced; 
• ensuring that transitional measures and temporary or permanent derogations are provided 
for, as appropriate, while upholding the requirement for all official laboratories to be 
accredited against ISO standard 17025. 
2.19.  The proposal also aims at improving the use of the rules on "administrative 
assistance" , i.e. the mechanism which allows cooperation between national control authorities on 
cross-border enforcement issues, where violations of  EU rules need to be pursued not only in the 
EU member State in which the violation was detect ed but also in the EU member State where it 
originates. A new EU-wide mechanism for the rapid exchange of information related to serious and widespread violations will also enable authorities to address fraudulent practices more effectively. 
2.4.2  Financing of official controls 
2.20.  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. A number of improvements to the current set of ru les 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. Micro- enterprises will be exempted from the payment 
of the fees. 
2.4.3  Imports 
2.21.  This revision will have a significant impact on the legal framework governing official 
controls on products from third countries . It provides a set of common rules for all control 
activities to be performed at EU borders on an imals and goods from third countries which require 
increased attention for health reasons. In this context, it introduces single Border Control Posts 
(BCPs)  designed to replace the current Border Inspection Posts (for animals and derived 
products), Designated Points of Entry  (for feed and food products of plant origin) and Points of 
Entry  (for plants and plant products). A uniform set of rules will apply to the controls carried out 
at the BCPs and a Common Health Entry Document  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.
1 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 in terms of the risk pose d by different categories of products. Provision is 
made for adopting further rules for specific sectors by means of implementing legislation. 
3  CONCLUSION 
3.1.  The agri-food industry is the second larg est economic sector in the European Union worth 
€750 billion a year. It is also one of the larges t employers, employing over 48 million people. 
EU consumers enjoy great diversity, reliability of supply and amongst the highest food safety 
standards in the world. This comprehensive revi ew of the legislative framework will deliver 
"smarter rules for safer food" for the benefit of  citizens and businesses alike. It will allow 
EU operators to source new markets for their products, well known for their quality and safety. 
Equally, it will allow operators in third countries the opportunity to seek new export markets within 
the European Union – all within a coherent, predic table, simple and yet well-regulated framework. 
 
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1 The Common Veterinary Entry Document (CVED) in the area of veterinary controls, the Common Entry 
Document (CED) for non-veterinary controls, and the ph ytosanitary certificate currently in use in the plant 
health sector.