The European Commission recently published a package of measures to strengthen the enforcement of health and safety standards for the entire EU agri-food chain. Following European Parliament and Council approval, the legislative package would condense existing EU food safety laws into five pieces of legislation to facilitate compliance with controls, inspections and testing. The package intends to harmonise the existing regulatory scheme on official controls, animal health, and control of pests on plants and plant reproductive material (including seeds).


The legislative package proposed by the European Commission consists of five Regulations that aim to harmonise and simplify the animal and plant health sectors of the agri-food chain in the EU. These five Regulations will cover:

  • animal health;
  • plant health;
  • plant reproductive material;
  • official controls, and;
  • expenditure for the entire agri-food chain under the Common Financial Framework.

A modernised and more risk-based approach to the protection of health is proposed, as well as more efficient control tools.

The new rules should enable Member States to strengthen enforcement of EU food safety legislation and to carry out sufficient controls.

Special consideration is given to SME's and very small companies which would be exempted from the most costly and burdensome elements of the proposed legislation.

On 13 June 2013, the European Commission organized a full day conference on the entire legislative package to explain the proposed rules further and gather feedback from stakeholders.

Main elements of the package

  1. Animal health

The proposal for a Regulation on animal health constitutes a follow-up to the Animal Health Strategy communicated by the European Commission in 2007 and is based on the OIE (World Organization for Animal Health) codes on standard setting for terrestrial and aquatic animal health. It aims to improve standards in general and to provide a common system to detect and control disease and tackle safety risks in a coordinated fashion. The proposal:

  • covers transmissible diseases in kept and wild animals thus extending the scope beyond food producing animals only;
  • takes a risk-based approach to the prioritisation and listing of diseases for EU intervention that are likely to have a significant impact on public health, agricultural or aquaculture production, and society in general;
  • differentiates with respect to the registration and approval requirements for establishments and the keeping of animals and animal products;
  • defines the primary responsibility of operators (animal keepers) for animal health who are now, for example, required to acquire basic knowledge of animal health; and
  • details more explicit rules for the regulatory framework for vaccination.

A stronger intervention system to tackle disease outbreaks or the control and prevention of such incidents should enable operators, traders and veterinary authorities in all EU Member States to benefit from a strengthened surveillance and emergency response system at national and EU level. This implies that EU Member States will have to regulate accordingly and adopt more detailed legislation where necessary.

  1. Plant health

In the area of plant health, the European Commission proposes to upgrade the existing plant health regime in response to the emergence of new plant pests that are related to the globalisation of trade and climate change. The proposed Regulation introduces:

  • precautionary measures to restrict high-risk trade from non-EU countries including better traceability data. The Commission may adopt implementing acts, including a temporary prohibition of introduction into the Union, to address emerging risks from certain plants for planting coming from certain third countries and which require stricter precautionary measures;
  • a requirement for EU countries to carry out surveys in their territory for outbreaks of new and dangerous pests;
  • a requirement for professional operators to be registered;
  • stronger action against pests of prime priority at EU level. Pests with higher priority will be subject to stringent obligations concerning preparation and eradication, supplemented by EU financial support for corrective action if necessary;
  • harmonised plant passports for plants transported between professionals within the EU. Instead of a lot number, the plant passport may use a chip, barcode or hologram linking it to the internal traceability systems of professional operators. Operators may apply for the passport and the certification label under the proposed Plant Reproductive Material Regulation in the same application (see below). Exemptions for SME's and sales to final non-professional consumers are provided for;
  • financial compensation for growers hit by quarantined pests (including a special arrangement for micro-enterprises); and
  • upgraded standards for pest-free 'protected zones', to bring them into line with the International Plant Protection Convention.

EU co-financing will be made available for surveillance and, in certain cases, for financial compensation for direct losses of professional operators as a result of damage during the eradication of pests.

Member State authorities should also provide compensation to anyone affected by their right to property when the competent authorities of Member States need to be granted access to private premises for official controls.

  1. Plant reproductive material (and seeds)

Current rules on plant reproductive material (PRM) are covered by twelve individual EU Directives which will now be consolidated into one EU Regulation. The proposed Regulation would provide for:

  • a single procedure for the registration of a new variety/material and for the granting of plant certification labels. This will require the keeping of a national register which may be audited by the EU register;
  • a single registration application for operators which will be aligned with registration under the Plant Health proposal referred to above under 2.;
  • light registration rules for old traditional varieties and for heterogeneous material including an exemption from testing and other requirements of the legislation;
  • the reduction of administrative burdens on micro-enterprises who can market any type of material as 'niche market material' without registration and are also exempted from registration fees; and
  • an EU equivalence scheme for trade in exports will apply so that exports would take place in line with legislation, standards, code of practice or any other legal or administrative procedure in place in the importing third country.

The following categories would be entirely exempted from the proposal:

  • exchanges between non-professional operators;
  • conservation by gene banks;
  • PRM kept for testing and scientific purposes;
  • private seed growers and private gardens.
  1. Official controls

The responsibility for enforcing food chain legislation currently lies primarily with EU Member States. Triggered by the recent horse meat scandal, the European Commission aims to strengthen these controls through:

  • sufficiently dissuasive financial penalties and the application of appropriate criminal and/or administrative penalties on operators who fail to cooperate during an official control;
  • the performance of regular mandatory unannounced official controls (including inspections and testing) directed at combating food fraud which Member States would need to include in their control plans;
  • the accreditation of all official laboratories, including those in the plant health sector which were not previously designated;
  • coordinated testing programmes in specific cases that are imposed, not only recommended, by the European Commission, in particular concerning fraud;
  • mandatory fees charged by the official authorities on almost all operators for official control activities in order to verify compliance with agri-food chain rules, attainment of certificates of compliance, border controls and emergency measures. These fees would be calculated on the basis of actual costs or set at a flat rate level with a reduction for compliance. Member States would decide at what level (local, regional, national) the fees are to be established and collected, depending on how their competent authorities are organised;
  • measures that ensure full cost recovery is achieved for the inspection activities;
  • Common Health Entry Document's which shall be required for all animals and goods entering the Union;
  • closer cooperation between competent authorities, customs authorities and other authorities involved in the handling of animals and goods arriving from third countries;
  • designation of national reference laboratories; and
  • designation of the single competent authority responsible for the national control plan.

Micro-enterprises, companies who employ fewer than 10 persons and whose annual turnover or balance sheet does not exceed EUR 2 million, would be exempted from paying fees. SMEs are not mentioned and thus would have to pay mandatory fees where they do not qualify as micro-enterprises.

For more details, see our update of 8 April 2013 "EU to propose tighter official food and feed controls and sanctions?"

  1. Common Financial Framework for food and feed

A new Regulation on the expenditure for the entire agri-food chain would provide common rules for EU funding priorities related to the enforcement of the new package. The Regulation would be adopted following agreement on the Multiannual Financial Framework (MFF) 2014-2020 for the EU. Final agreement with the European Parliament is still needed for the new MFF to enter into force in January 2014. The rules which are yet to be established by the European Commission would provide the basis for the implementation of EU funded measures and would aim to ensure that cost-effective solutions are found.

Next steps

These proposals are still at an early stage of the legislative procedure. They will be examined by the European Council and the European Parliament, and both institutions can provide input through amendments before voting on whether the various proposals should pass. The legislative process is likely to take at least 18 - 24 months from the moment the proposal is put forward. The Commission does not expect adoption of the entire package before 2016.


If adopted, the new rules would have huge impact on the entire agri-food chain within and outside the EU.

Although, at the recent stakeholder consultation organized by the European Commission, the package was largely welcomed and generally regarded as an opportunity to simplify the rules currently in place, concerns were raised on a number of issues. For example, many aspects of the new legislation are yet to be drafted and implemented via delegated acts. Stakeholders, therefore, expressed concern over the lack of transparency and information on how the general aspects presented will be implemented and thus play out in practice. Stakeholders are also calling for smooth transition measures should an outbreak of a particular disease for example occur during the transition period for implementation of the package. Farmer representatives expressed concern over the likely burden and costs resulting from inspections.

It seems that EU Member States and third countries will also need to agree on the different pest categories that exist since plants or plant diseases that may be considered as a pest in the EU, may not be considered as such by a third country.

As regards funding of controls, stakeholders appear divided between those that see controls as a burden and cost to the industry, which should be carried by the authorities within their mission of public interest to ensure food safety, and those that perceive it as a possibility for industry to increase trust in their products and prove that they comply with applicable requirements.

The proposed Regulations would provide for transition periods enabling food business operators to transition to the new rules. The proposals on animal health, plant health and on plant reproductive material contain a transitional period of three years after their publication in the Official Journal of the European Communities. Official controls however, are proposed to come into effect one year following official publication of the new Regulation

Operators affected by these measures would have an interest in monitoring the process closely and where necessary have their voice heard as modifications may be introduced by the Council and the European Parliament over the next 18-24 months.