Food safety

European food safety policy aims are twofold: to protect human health and consumers’ interests, and to foster the smooth operation of the single European market. The EU thus ensures that control standards are established and adhered to in the areas of feed and food-product hygiene, animal health, plant health and the prevention of food contamination from external substances. The Union also regulates labelling for food and feed products.

Legal basis

Articles 43, 114, 168(4) and 169 of the Treaty on the Functioning of the European Union.

General background

In the wake of a series of human food and animal feed crises (e.g. the BSE outbreak and the dioxin scare), EU food safety policy underwent deep reform in the early 2000s. The ‘Farm to Fork’ approach was defined, guaranteeing a high level of safety at all stages of the production and distribution process for all food products marketed within the EU, whether produced within the EU or imported from third countries. This body of legislation forms a complex and integrated system of rules covering all the links in the food chain.


a.General legislation

The general principles of current food law entered into force in 2002 with Regulation (EC) No 178/2002. This framework regulation also established the European Food Safety Authority (EFSA), tasked with assessing and informing on all risks related to the food chain. The regulation takes into account the ‘precautionary principle’ (5.4.1), sets out a risk assessment approach, and establishes general provisions for imposing traceability of food and feed. It also establishes the Rapid Alert System for Food and Feed (RASFF), allowing Member States and the Commission to exchange information rapidly and to coordinate their responses to health threats caused by food or feed.

b.Hygiene of foodstuffs

In April 2004, as part of the ‘Farm to Fork’ approach, a new legislative framework known as the Hygiene Package was adopted (Regulation (EC) No 852/2004 on the hygiene of foodstuffs, Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal origin, and Regulation (EC) No 854/2004 putting in place a Community framework for official controls on products of animal origin intended for human consumption, which also lays down specific rules for fresh meat, bivalve molluscs, milk and milk products). The package places the responsibility for foodstuffs hygiene directly with the various players in the food chain through a self-regulating system using the HACCP method (‘hazard analysis and critical control points’), monitored by means of official controls that must be conducted by the competent authorities, as laid down in Regulation No 854/2004 as amended by Regulation No 882/2004.

c.Food contamination

1.Safe food

Council Regulation (EEC) No 315/93 was adopted in order to ensure that no foodstuffs containing unacceptable quantities of contaminant substances may be marketed. The limits currently applying to the most important contaminants are set out in Commission Regulation (EC) No 1881/2006, which establishes maximum levels for contaminants in food (e.g. nitrates, mycotoxins, heavy metals and dioxins) and requires their regular review.

2.Maximum residue limits

Residues in foodstuffs could originate in pesticides or veterinary medical treatments and biocidal products used. Residues of pesticides are regulated by Regulation (EC) No 396/2005, which, replacing previous legislative acts, sets the rules for all agricultural products. Maximum residue limits and regulated substances are updated periodically by specific Commission regulations. As far as residues in animals are concerned, the authorised substances and their corresponding maximum residue limits are listed in Regulation (EC) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin.

3.Contamination caused by materials in contact with food

The rules on materials in contact with food are set out in Regulation (EC) No 1935/2004. This framework regulation lays down the general requirements for all relevant materials and articles; specific EU measures containing more detailed provisions may be adopted for the 17 food contact materials and articles (FCMs) listed in Annex I thereto. In relation to plastics, for example, Regulation (EU) No 321/2011 introduced restrictions on Bisphenol A, used in plastic infant feeding bottles. Only four materials are currently subject to specific EU measures. For the other materials, Member States may adopt national provisions. The Commission’s Joint Research Centre is currently carrying out a study to provide a comprehensive overview of the current situation concerning FCMs for which no specific measures are in place at EU level.

d.Food labelling

1.Legislation on food labelling

The legal framework concerning foodstuff labelling is designed to guarantee consumers access to complete information on the content and composition of products in order to protect their health and best interests. On 13 December 2014, a new regulation (Regulation (EU) No 1169/2011) came into force which combines two directives into one piece of legislation. These are: Council Directive 2000/13/EC on labelling, presentation and advertising of foodstuffs; and Council Directive 90/496/EC on nutrition labelling for foodstuffs as amended by Commission Directive 2003/120/EC.

The main novelty is the requirement for producers to indicate the presence of allergens in non-packaged foods, e.g. in restaurants and canteens, the origin of unprocessed meat (for certain types of meat other than beef, which already has to be labelled for origin), and the presence of food imitations, such as vegetable products replacing cheese or meat. Specific provisions on nutrition information on processed foods will enter into force on 13 December 2016. Commission Regulation (EU) No 1337/2013 sets out the modalities requiring (with some exceptions) the indication of the place of rearing and place of slaughter of pre-packaged fresh, chilled and frozen meat of swine, sheep, goats and poultry. The new rules have been applicable since 1 April 2015.

2.Health and nutritional claims, and food for specific groups

Regulation (EC) No 1924/2006 governs nutrition and health claims made about food. Directive 2009/39/EC establishes a framework with general rules for ‘dietetic foods’, including food for infants and young children, and sets out requirements for their composition, marketing and labelling to ensure product safety. In June 2013, Parliament adopted a new regulation on ‘Food for Specific Groups’ (FSG) (Regulation (EU) 609/2013), abolishing the concept of a broad category of ‘dietetic’ food in favour of rules for specific groups: food for infants and young children, food for special medical purposes, and total diet replacement for weight control. The legislation will enter into force in July 2016.

e.Food additives and flavourings

1.Food Improvement Agents Package (FIAP)

Food additives are substances not normally consumed in their own right which are added intentionally to foodstuffs to perform certain technological functions (for example colourings, sweeteners or preservatives). In 2008, a new legislative package of four regulations ((EC) No 1331/2008, 1332/2008, 1333/2008 and 1334/2008) was adopted concerning the authorisation procedure, conditions of use and labelling of food additives, food enzymes and food flavourings.

2.Food supplements and addition of vitamins and minerals

Directive 2002/46/EC establishes harmonised rules for the labelling of food supplements and introduces specific rules on vitamins and minerals in food supplements. Regulation (EC) No 1925/2006 harmonises the provisions laid down in Member States for the addition to foods of vitamins, minerals and certain other substances.

f.Animal and plant health

EU rules include general provisions on the surveillance, notification and treatment of infectious diseases and their vectors, in the form of, respectively, Directive 2003/99/EC of the European Parliament and the Council, Council Directive 82/894/EEC and Council Directive 92/119/EEC. The current legislative framework for the organisation of official controls has been established through Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law and animal health and welfare rules.

In May 2013, the Commission presented a new legislative package that includes proposals on animal health, plant health, plant reproductive material and official controls. The package provides a more risk-based approach to the protection of health, aiming to increase the efficiency of official controls in order to avoid food crises and cases of fraud as much as possible. The new EU Animal Health Law (Regulation (EU) 2016/429 on transmissible diseases) was adopted in March 2016. The entry into force of the new plant health regime is expected by the end of 2016, while the new regulation on official controls is still under negotiation.

g.Legislation on animal feed and feed labelling.

Regulation (EC) No 183/2005 governs animal feed hygiene. Regulation (EC) No 767/2009, adopted in July 2009, brings together most legislation on the labelling and marketing of feed. Directive 2002/32/EC on undesirable substances in animal feed includes maximum limits for heavy metals and prohibits the dilution of contaminated feed materials. Directive 2002/70/EC establishes requirements for determining levels of dioxins and dioxin-like PCBs in feedstuffs. Both veterinary medicines (which are governed by, in particular, Directive 2001/82/EC and Regulation (EC) No 726/2004) and medicated feed (Directive 90/167/EEC) are currently under revision.

h.Novel foods

Regulation (EC) No 258/97 stipulated that novel foods (i.e. those not consumed to a significant degree before the regulation’s entry into force) had to undergo a safety assessment before being marketed in the EU. It was subsequently incorporated into Regulation (EC) No 1852/2001. In 2008, the Commission presented a proposal to update the legislation on novel foods but, owing to a disagreement between Parliament and the Council over how to regulate food from cloned animals, no new legislation entered into force. In December 2013, the Commission presented a new proposal. In 2015, Parliament and the Council finally reached an agreement, with the new Regulation (EU) 2015/2283 entering into force on 31 December 2015. Until specific legislation on food from cloned animals enters into force, such food falls under the scope of this regulation and should therefore be labelled appropriately.

i.Genetically modified organisms (GMOs)

A GMO is ‘an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination’. Directive 2001/18/EC on the deliberate release into the environment of GMOs regulates their cultivation and commercialisation and, along with Regulations (EC) No 1829/2003 and (EC) No 1830/2003, defines the Union’s regulatory framework (including mandatory labelling of food made from or containing GMOs) in this area. With the authorisation of the cultivation of the Amflora potato in March 2010, the Commission ended the moratorium on new cultivation of GMOs that had been in force since 1998. In January 2015, new legislation (Directive (EU) 2015/412) was adopted, amending Directive 2001/18/EC, to allow Member States to restrict or ban the cultivation of crops containing genetically modified organisms (GMOs) on their own territory, even if this is allowed at EU level. The legislation was originally tabled in 2010 but was then deadlocked for four years owing to disagreement between pro- and anti-GMO Member States. In April 2015, the Commission proposed complementary legislation amending Regulation (EC) No 1829/2003 as regards the possibility for Member States to restrict or prohibit the use of genetically modified food and feed on their own territory. The proposal was rejected by Parliament in October 2015, because of, inter alia, the lack of an impact assessment, the issue of compatibility of measures taken by Member States with the internal market and WTO rules, and the practicability of the proposal. The Council has not yet taken any formal decision.

Role of the European Parliament

In response to crises such as the BSE outbreak in 1996 and the epidemic of foot and mouth disease in 2002, temporary committees were set up to investigate alleged shortcomings in the implementation of European law. Parliament is also particularly vigilant with regard to threats to consumer health related to cloned animals and nanomaterials. In order to ensure greater transparency throughout the food chain and to better inform European consumers, Parliament, in a resolution adopted in May 2016[1], reiterated its call on the Commission — as already expressed in the past[2] — to present legislative proposals for the mandatory indication of the origin of, in particular, meat used as an ingredient in processed foods. This should also restore consumer confidence in the wake of the horsemeat scandal in 2013 and other food fraud cases.

[1]European Parliament resolution of 12 May 2016 on mandatory indication of the country of origin or place of provenance of certain foods - Texts adopted, P8_TA(2016)0225.

[2]European Parliament resolution of 11 February 2015 on country of origin labelling for meat in processed food — Texts adopted, P8_TA(2015)0034.

Nora Hahnkamper-Vandenbulcke