Chapter 12- Food Safety, Veterinary and Phytosanitary

Chapter 12 covers comprehensive rules in field of food safety, veterinary and phytosanitary. The majority of EU acquis is within the scope of this chapter.

This chapter has three main titles;

Food Safety

Food safety includes rules for food information to consumers and consumer protection, hygiene and presentation rules, mechanisms for guarantee of food safety and rules for controls as well as hygiene rules for processing and placing on the market of food, particularly products of animal origin.


Veterinary legislation covers intra-community trade of live animals and animal products, control and eradication of animal diseases, technical and administrative rules for products from third countries and control rules for production of products of animal origin. In addition there are detailed rules concerning the notification of animal diseases, administrative structure and mechanism in regard to animal identification and monitoring movements of animals. This detailed legislation determining the detailed rules, requires importation of live animals and animal products via border inspection posts specifically equiped for this purpose.


Phytosanitary field covers rules on controls of harmful organism on plant and products of plant origin, use of plant passport in trade of plants for planting purposes, procedures of authorisation of plant protection products, internal and external quarantine measures, residues of plant protection products in products of plant origin, quality of seed and seedling and marketing of these products.

Negotiation discussions for Chapter 12 began with explanatory meetings and bilateral meetings in 2006. Explanatory meeting was held between 9-15 March 2006, bilateral meeting was held between 24-28 April 2006.

During explanatory meeting, EU acquis was presented to Turkish delegation. Turkish legislation and their implementations were explained to the representatives of EU during bileteral meeting. After these meetings, EU prepared screening report which consists of state of play in Turkey, differences of legislation and implementation and actions. This report guided for works at following process. Then, opening benchmarks were delivered Turkish side in the scope of this report.

Chapter 12 was opened to negotiations at 9th Intergovernmental Accession Conference held in Brussels, 30 June 2010 after Turkey's preparations for meeting of opening benchmarks. As Turkish agricultural products including processed products are found safe by EU in regard to health, quality and standard, it is expected that Turkish agricultural products will gain easy access to the market and competitiveness in regionally and globally, the level of consumers' confidence and awareness will increase with harmonising acquis of this chapter.​

General Food Law

In 2002, the European Parliament and the Council adopted Regulation (EC) No 178/2002 laying down the general principles and requirements of food law (General Food Law Regulation).

The General Food Law Regulation is the foundation of food and feed law. It sets out an overarching and coherent framework for the development of food and feed legislation both at Union and national levels. To this end, it lays down general principles, requirements and procedures that underpin decision making in matters of food and feed safety, covering all stages of food and feed production and distribution.

It also sets up an independent agency responsible for scientific advice and support, the European Food Safety Authority (EFSA). Moreover, it creates the main procedures and tools for the management of emergencies and crises as well as the Rapid Alert System for Food and Feed (RASFF).

The General Food Law Regulation ensures protection of human life and consumers' interests in relation to food, while ensuring the effective functioning of the internal market.

Official Controls

European Commission announced a set of actions for developing legislation on food and feed controls in "White Paper on Food Safety" dated 12 January 2000. In this context, Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules was adopted by the European Parliament and of the Council of 29 April 2004

Financing of official controls- The Articles 26-29 of 882/2004

Fees or charges paid by the food or feed businesses are the financial resources for organising official controls by the Member States.

The Member States finance the official controls with appropriate means including through general taxation or by establishing fees or charges. But the Member Mtates should ensure collecting of mandatory fees in some sectors having intensive official controls (meat, milk, fishery, import etc.). These areas are listed in the Annex IV and Annex V of the Regulation.


Additional controls on imported foodstuffs of non animal origin

Commission Regulation (EC) No 669/2009 amending Decision 2006/504/EC was adopted on July 2009 for ensuring to counter more effectively to emerging risk linked to feed or food of non-animal origin.

The Member States must have designated points of entry in order to meet minimum requirements of the Regulation. Additional control mechanism is a systematic mechanism which consists of documentary and physical checks on all consignments including laboratory analysis of which frequency is based on determined risk.

This regulation lists feed and food of non-animal origin subject to import controls. Listed products are required further controls at designated points of entry according to information collected from different sources ( RASSF notifications, reports of FVO etc.).​

Novel Foods and Novel Food Ingredients

European Commission defines foods and food ingredients which were not used for human consumption to a significant degree in the Community before 15 May 1997 as novel foods and novel food ingredients. They must be safe for consumers and properly labelled to not mislead consumers.


There are additional requirements for novel food and novel foods ingredients in addition to EU general labelling requirements. If it is needed, labels of novel foods and novel food ingredients indicate any characteristic information (intended use, nutritional value, composition), possible effects on health of certain sections of the population and the presence of a material causing ethical concerns.

Safeguard measures

If a Member State considers a risk to human health or the environment deriving from novel food and novel food ingredient, Member State can suspend placing it on the market or restrict temporarily in its territory. The Commission informed by the Member States can expand the measure for all Member States or recall from the market.​


Food HygieneBy the White paper on food safety Commission outlines the rules about food safety and hygiene for EU and according to these rules food operators are primarily responsible for food safety. New legislations simplifies, unifies and harmonize the previous detailed requirements set by Council Directives about food hygiene and production and marketing products of animal origin.. TSE/BSE                                                                                   Transmissible Spongiform Encephalopathies (TSE) refer a group of diseases occurring in man and animals and  characterized by degenerative brain tissue that give the brain a "spongy" appearance and potentially lethal. In this group of diseases Creutzfeldt Jakob Disease (CJD) and Kuru Disease in humans, BSE in cattle and Scrapie Disease in small ruminants, Chronic Wasting Disease in deer and etc are present.   EU Rules about Animal By-Products (ABP) ABP’s may spread animal diseases and/or chemical contaminants and if not adequately removed can harm human and animal health. EU rules set appropriate measures for transfer, process and disposal of these by-products. ABP’s are categorised according to risk categories defined in EU regulation 1069/2009.Food-borne DiseasesZoonoses such as brusellosis, salmonellosis and listeriosis can directly infect humans from contaminated food. Because of this fact the animal health is overwhelmingly important. EU legislation about animal health covers zoonotic animal diseases which transmitted from animals to humans (64/432/EEC, 91/68/EEC). Specific measures against zoonoses are present in veterinary public health legislation. As an example, brusellosis and tuberculosis status of milk production establishments are laid down in 92/46/EEC Council Directive and Cysticercus and Trichinella like parasites detection standards in meat are laid down in meat hygiene legislation (853/2004/EC, 854/2004/EC and 2075/2005/EC).Microbiological CriteriaMicrobiological criteria are used to determine food quality and safety. For food the Community microbiological criteria have been updated and important new criteria have been laid down. EU legislation for Microbiological Criteria for food is 2073/2005/EC, applicaple since 1 January 2006. Antimicrobial Resistance (AMR)When micro-organisms became resistant to one or more antimicrobial agents such as antibiotics they develop antimicrobial resistance (AMR)..Because of widespread use of existing antimicrobials and slow introduction of new antimicrobial in use, AMR became a serious health problem.


Genetically Modified Food and FeedIn recent times, genetic modification of living cells and organisms has become possible by using techniques of modern biotechnology. The genetic material is modified artificially to give it a new property (e.g. a plant's resistance to a disease, insect or drought, a plant's tolerance to a herbicide, improving a food's quality or nutritional value, increased yield). Such organisms are called "genetically modified organisms" (GMOs). Food and feed which contain or consist of such GMOs, or are produced from GMOs, are called "genetically modified (GM) food or feed".The European Union has established a legal framework to use modern biotechnology and to ensure the development of GMOs takes place in safe conditions.Genetically Modified Food and Feed  in the EU The European Union has a comprehensive legal framework in place for the authorization, traceability and labelling of GMOs. Regulation (EC) No 1829/2003 on genetically modified food and feed covers food, food ingredients, and feed containing, consisting of or produced from GMOs.  Directive 2001/18/EC is the other legislation in this are which lays down the deliberate release into the environment of genetically modified organisms for uses other than food and feed.In 2010, the Commission submitted a proposal to amend the GMO legislation to extend the grounds on which Member States could restrict or prohibit the cultivation of EU authorized GMOs on their territory. The proposed amendment has now been adopted into EU law as Directive (EU) 2015/412. Labelling of GM Food and FeedTraceability and labelling of genetically modified organisms and food and feed products produced from genetically modified organisms are laid down in the regulation (EC) 1830/2003. All the products covered by this Regulation are subject to compulsory labelling. The specific requirements of this Regulation are applied in addition to the  general labelling rules applicable to food and feed.

Food Labelling

EU food labelling rules, adopted by the European Parliament and the Council in 2011, ensure that consumers receive clearer, more comprehensive and accurate information on food content, and help the consumers to make informed choices about what they eat as of 13 December 2014. The obligation to provide nutrition information will apply from 13 December 2016.Regulation (EU) No 1169/2011 on the provision of information to consumers replaces and combines into one piece of legislation previous labelling rules which are deriving from 2000/13/EC regarding labelling, presentation and advertising of foodstuffs and Directive 90/496/EEC on nutrition labelling of foodstuffs and other legislative acts for specific categories of foods.

Health and Nutrition Claims

In December 2006, the Regulation on nutrition and health claims made on foods was adopted by the Council and Parliament. For the first time, this Regulation lays down harmonised rules across the European Union for the use of nutrition claims such as “low fat”, “high fibre” or health claims such as “reducing blood cholesterol”. Health ClaimsA health claim is any statement about a relationship between food and health. The Commission draws up lists of health claims including the different types of authorised and rejected health claims in the EU.Nutrition Claims Nutrition claim means any claim which states, suggests or implies that a food has particular beneficial nutritional properties. Nutrition claims are only permitted if they are listed in the Annex of Regulation (EC) No 1924/2006, lastly amended by Regulation (EU) No 1047/2012.

EU Plant Health Policy

EU plant health policy includes harmful organisms, plant protection materials, plant property rights and seed and propagation.

Harmful Organisms

Fundamental principles of EU plant health policy are to take protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community.

EU plant health regime is regulated with Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community. Since 2013, studies on preparing a new plant health regulation have been carried out.

Procedures on registering the producers within the Community is laid down in the Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Member States of harmful organisms of plants or plant products and Commission Directive 92/90/EEC of 3 November 1992 establishing obligations to which producers and importers of plants, plant products or other objects are subject and establishing details for their registration.

If the results of the checks are satisfactory, instead of a phytosanitary certificate a passport and the rules applicable to intra-Community movement apply. The passport may be replaced in certain circumstances (change of plant health status, division into batches, etc.) and subject to certain conditions.

Plant passport system which is a prerequisite of the EU Single Market depends on registration of the producers, permissions for arrangement, record keeping and issuing of plant passports and control regime. Plant passports take the place of the plant health certificates in the internal market but at the same time it requires for the producers, traders and plant protection agencies to take more responsibility on the prevention of entrance of harmful organisms and their spread.

Related EU legislations are; "Commission Directive 92/105/EEC of 3 December 1992: establishing a degree of standardization for plant passports to be used for the movement of certain plants, plant products or other objects within the Community, and establishing the detailed procedures related to the issuing of such plant passports and the conditions and detailed procedures for their replacement" and "Commission Directive 2005/17/EC of March 2005 amending certain provisions of Directive 92/105/EEC concerning plant passports".

Another issue that is involved in the plant health regime is the Protected Areas issue. These areas are the areas where within the Community, by the request of a Member Country where special measures could be taken against one or more of the harmful organisms that is mentioned in the Council Directive 2000/29/EC. These areas are the ones that these particular harmful organisms don't exist but because of the environmental conditions that is suitable for the settle of these said organisms. In some cases, harmful organism can exist in the protected area but eradication practices are can be ongoing.

Plant Protection Products

There are two main subjects in the European Union, related to plant protection products. First of these is issuing of a marketing authorization and introducing to market, second one is maximum residue limits

First one of these legislations that has been introduced in 2009 is Regulation (EC) No 1107/2009 of The European Parliament and of The Council of 21 October 2009 concerning the placing of plant protection production on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. When the regulation examined, it will be understood that it went into effect in 14 December 2009 and Member Countries have to apply it by the 14 June 2011. This Regulation harmonizes the rules related to introduction of plant protection products to market Scope of this regulation is plant protection products and their active substances. This regulation sets out the rules for approval criteria of the active substances.

Classification, labelling and packaging conditions for the plant protection products are defined in 1999/45/EC related to dangerous preparations.

In the Directive 2009/128/EC of the European Parliament and of the Council, the frame for the sustainable use of pesticides is defined. But application of this Directive in the Member States is started in 25 November 2011. If the basis subject of the Directive is examined, it will be understood that the goal is to ensure a sustainable use of pesticides in order to reduce the risks on human health and environment.

Plant Variety Rights

The system regarding to plant variety rights are established by Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights. This system allows all intellectual property rights to be valid in whole of the Union that is given for all plant types. For the industrial property rights that will be given for new plant varieties, a single and exclusive mode of Community plant variety rights system is defined. This system is managed by Community Plant Variety Office (CPVO). Community plant variety right is defined in Regulation as an asset right. This right can be propounded and protected in every Member Country but it became necessary to determine which Member Country's law will be applied when these rights are subject to legal transactions. In this frame, Regulation provided some binding rules. Community plant variety right will be accepted as an intellectual property right in the Member State where the right owner has a domicile or a central enterprise during the registry of right or if the right owner does not have a domicile or a central enterprise during this period, in the Member State where its representative's domicile or central enterprise exists when Community plant variety right is subjected to a legal transaction.

Seed and Seedling Quality

European seed industry is in a fundamental supplier position for food and feed chain. Applying a certification system in order to provide a guarantee about the seed that is bought, variety purity and characteristic, providing seed guarantee with regard to germination capacity and specific purity, plant health for the users are the reasons why a Directive has been constituted related to seed and seedling quality.

Legislation in the EU related to seed and seedling quality consist regulations for; field crops, vegetables, vine, fruit, forest and ornamental plants, types that are conserved and common catalogues. The minimum quality standards for the seeds that are going to be sold are defined by the EU Directives. But there is no standards set in the EU Directives for any disease originating from the seeds. However, Member States has the rights to apply additional cautions or more strict cautions and therefore defining standards for diseases originating from the seeds. ​

EU Veterinary Policy


Import of Products (Council Directive 97/78/EC)

This Directive applies to products imported from third countries, particularly:

  • Foodstuffs of animal origin
  • Animal feed
  • Plant products which increase the risk of spreading of infectious or contagious animal diseases
  • By-products not intended for human consumption

According to this Directive, all consigments from third countries should be subject to veterinary controls before being placed on the EU market. These controls are carried out by the competent authority present at border inspection posts under the supervision of an official veterinarian.These controls consist of:

  • Document control: Verification of veterinary certificates and documents accompanying the consignment.
  • Identification control: Controls carried out to verify that the information provided in the accompanying certificate and documents match the information regarding the product.
  • Physical control: Controls carried out to verify that the products (packaging, temperature, sampling and laboratory test results) meet the requirements of EU legislation.

In situations which pose a serious threat to animal health or public health, the Commission may suspend the import or adopt special rules concerning the whole or a certain area of a country.

Controls on Live Animal Imports (Council Directive 91/496/EEC)

This Directive lays down the rules on external border controls and intra-Community movement of live animals coming from third Countries.

Veterinary Controls

According to this Directive, all live animal consignments coming from third countries should be subject to veterinary controls before being placed on the EU market. These controls are carried out by the competent authority present at border inspection posts under the supervision of an official veterinarian.

These controls consist of:

  • Document control: Verification of certificates and veterinary documents accompanying each animal consignment.
  • Identification control: Verification by comparing the information provided in the documents or certificates and the animal, and if present, the location of body markings by inspection
  • Physical control: Checking the live animal and if appropriate, carrying out additional controls during the quarantine period, including sampling and laboratory tests, if available.

Transit of Animals Coming from Third Countries

Council Directive 91/496/EEC lays down the conditions of animal transport from one third country to another. If necessary, the competent authority may decide to place the animals under quarantine, re-export them or send them to a slaughterhouse.

Intra-Community Trade and Import of Certain Animals and Their Semen, Ova and Embryos (Council Directive 92/65/EEC)

Council Directive 92/65/EEC lays down the animal health conditions necessary for the trade and import of live animals, semen, ova and embryos which are not specified under a specific Community legislation.

The Directive lays down the necessary health conditions for the trade of zoo animals, ungulates and birds, camels, bees, rabbits (lagomorphs), mink, foxes, etc. which are not covered by a specific directive and pet cats, dogs and ferrets.

TRACES System (Commission Decision 2003/623/EC)

Trade Control and Expert System (TRACES) has established a single and central database in order to trace the movements of animals and products of animal origin within the EU or coming from outside.


  • Electronical transmission of information
  • Central management of legal reference data
  • Ability to work with other information systems
  • Multilingual interface

By being involved in the TRACES system, the establishments can be registered by their competent authority.

Animal Health and Public Health: Other Products of Animal Origin (92/118/EEC)

Council Directive 92/118/EEC covers certain products of animal origin, particularly animal intestines not intended for human consumption, processed animal proteins intended for human consumption, blood and blood products of ungulates and poultry, poultry meat and farmed game.

The Council should authorise the trade or import of any new products of animal origin, afterwards an assessment should be made by the Commission and if appropriate, the opinion of European Food Safety Authority (EFSA) should be sought. This assessment is not only made for the animal species from which the product was derived, but is also made for other species which may carry the disease, become a source of disease or pose a risk to human health.

Placing on the Market of Purebred Animals (92/65/EEC)

Council Directive 92/65/EEC lays down the rules on the marketing of purebred animals other than cattle, swine, sheep, goat and horses and their semen, ova and embryos.
The following conditions should be met for placing on the market:

  • Criteria necessary for the approval of breeder organizations or associations
  • Criteria necessary for pedigree registration
  • Criteria necessary for the reproduction of purebred animals or the use of their semen, ova and embryos
  • Certificate necessary for placing on the market