General Principles of Food Law
Regulation (EC) No 178/2002 (OJ L31, p1, 1/02/2002) of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.
- Regulation (EC) No 1642/2003 (OJ L245, p4, 29/09/2003) of 22 July 2003
- Commission Regulation (EC) No 575/2006 (OJ L100, p3, 08/04/2006) of 7 April 2006 as regards the number and names of the permanent Scientific Panels of the European Food Safety Authority
- Commission Regulation (EC) No 202/2008 (OJ L60, p17, 05/03/2008) of 4 March 2008 as regards the number and names of the Scientific Panels of the European Food Safety Authority
- Regulation (EC) No 596/2009 (OJ L188, p14, 18/07/2009) of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Four
- Regulation (EU) No 652/2014 (OJ L189, p1, 27/06/2014) of the European Parliament and of the Council of 15 May 2014 laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations (EC) No 178/2002, (EC) No 882/2004 and (EC) No 396/2005 of the European Parliament and of the Council, Directive 2009/128/EC of the European Parliament and of the Council and Regulation (EC) No 1107/2009 of the European Parliament and of the Council and repealing Council Decisions 66/399/EEC, 76/894/EEC and 2009/470/EC
- Commission Regulation (EU) 2017/228 (OJ L35, p10, 10/02/2017) of 9 February 2017 amending Regulation (EC) No 178/2002 as regards the names and the areas of competence of the scientific panels of the European Food Safety Authority
- Regulation (EU) 2017/745 (OJ L117, p1, 05/05/2017) of the European parliament and of the council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
- Regulation (EU) 2019/1243 (OJ L198, p241, 25/07/2019) of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union.
- Consolidated Version of Regulation (EC) No 178/2002 (as at 26 July 2019)
- Regulation (EU) 2019/1381 (OJ L231, p1, 06.09.2019) of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC.
Commission Regulation (EC) No 2230/2004 (OJ L379, p64, 24/12/2004) of 23 December 2004 laying down detailed rules for the implementation of European Parliament and Council Regulation (EC) No 178/2002 with regard to the network of organisations operating in the fields within the European Food Safety Authority’s mission
Commission Implementing Regulation (EU) No 931/2011 (OJ L 242, p2, 20/09/2011) of 19 September 2011 on the traceability requirements set by Regulation (EC) No 178/2002 of the European Parliament and of the Council for food of animal origin
Commission Implementing Decision (EU) 2019/300 of 19 February 2019 establishing a general plan for crisis management in the field of the safety of food and feed OJ L 50, 21.2.2019, p. 55–65
For food businesses supervised by the Health Services Executive (HSE)
European Communities (General Food Law) Regulations 2007 (S.I. No. 747 of 2007)
- European Communities (General Food Law) (Amendment) Regulations 2010 ( S.I. 498 of 2010)
- European Communities (General Food Law) (Amendment) Regulations 2011 ( S.I. 500 of 2011 )
- European Communities (GeneralFood Law) (Amendment) Regulations 2012 (S.I. 473 of 2012)
- European Communities (General Food Law) (Amendment) Regulations 2013 (S.I. No. 383 of 2013)
For food businesses supervised by the Department of Agriculture, Food and Marine (DAFM), the Sea-Fisheries Protection Authority (SFPA) or Local Authorities
European Communities (Food and Feed Hygiene) Regulations 2009 (S.I. 432 of 2009)
- European Communities (Food and Feed Hygiene) (Amendment)Regulations 2010 ( S.I. No. 312 of 2010 )
- European Communities (Food and Feed Hygiene) (Amendment) Regulations 2012 (S.I. No. 164 of 2012)
- European Communities (Food and Feed Hygiene) (Amendment) (No 2) Regulations 2012 (S.I. No 362 of 2012)
- European Communities (Food and Feed Hygiene)(Amendment) Regulations 2015 (S.I. No 68 of 2015)
- European Communities (Food and Feed Hygiene)(Amendment) (No. 2) Regulations 2015 (S.I. No. 306 of 2015)
Regulation (EC) 178/2002 establishes the common basis for food law in Member States and includes common definitions, general provisions and specific requirements. This Regulation also established the European Food Safety Authority (EFSA) and laid down the procedures in matters of food safety. The objective of the Regulation is to ensure a high level of protection for consumers whilst also taking into account the protection of animal health and welfare, plant health and the environment.
Regulation (EC) 178/2002 is given effect in Irish legislation by:
- S.I. No. 432 of 2009 in so are as it relates to the work of the Department of Agriculture, Fisheries and Food, Local Authorities and the Sea Fisheries Protection Authority
- S.I. No. 747 of 2007 in so far as it relates to food and the work carried out by envirnomental health officers of the Health Service Executive (HSE)
The Regulation sets out the general requirements of food law which include food safety requirements, responsibilities of both food and feed business operators and Member States. The Regulation establishes the principle that the primary responsibility for ensuring compliance with food law, rests with the food business operator.
Food business’ is defined in the Regulation as meaning any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of production, processing and distribution of food. 'Food business operator’ means the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control. The European Commission has published a poster on the Key Obligations of a Food Business Operators.
Regulation (EC) No 178/2002 defines food as any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. ‘Food’ includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment. It includes water after the point of compliance as defined in Article 6 of Directive 98/83/EC and without prejudice to the requirements of Directive 2009/54/EC and 98/83/EC.
‘Food’ shall not include:
- live animals unless they are prepared for placing on the market for human consumption;
- plants prior to harvesting;
- medicinal products within the meaning of Council Directives 65/65/EEC1 and 92/73/EEC;
- cosmetics within the meaning of Council Directive 76/ 768/EEC;
- tobacco and tobacco products within the meaning of Council Directive 89/622/EEC;
- narcotic or psychotropic substances within the meaning of the United Nations Single Convention on Narcotic Drugs, 1961, and the United Nations Convention on Psychotropic Substances, 1971;
- residues and contaminants.
Article 14 of Regulation (EC) No 178/2002 sets out food safety requirements. It requires that food must not be placed on the market if it is unsafe.
Food shall be deemed to be unsafe if it is considered to be:
- injurious to health;
- unfit for human consumption.
In determining whether any food is unsafe, regard shall be had:
- to the normal conditions of use of the food by the consumer and at each stage of production, processing and distribution, and
- to the information provided to the consumer, including information on the label, or other information generally available to the consumer concerning the avoidance of specific adverse health effects from a particular food or category of foods.
In determining whether any food is injurious to health, regard shall be had:
- not only to the probable immediate and/or short-term and/or long-term effects of that food on the health of a person consuming it, but also on subsequent generations;
- to the probable cumulative toxic effects;
- to the particular health sensitivities of a specific category of consumers where the food is intended for that category of consumers.
In determining whether any food is unfit for human consumption, regard shall be had to whether the food is unacceptable for human consumption according to its intended use, for reasons of contamination, whether by extraneous matter or otherwise, or through putrefaction, deterioration or decay.
Where any food which is unsafe is part of a batch, lot or consignment of food of the same class or description, it shall be presumed that all the food in that batch, lot or consignment is also unsafe, unless following a detailed assessment there is no evidence that the rest of the batch, lot or consignment is unsafe.
Regulation (EC) No 178/2002 contains general provisions for traceability (Article 18) which require that the traceability of food, feed, food-producing animals and any other substance intended to be, or expected to be, incorporated into a food or feed must be established at all stages of production, processing and distribution. This Article has been applicable since 1st January 2005.
Food business operators must be able to identify any person from whom they have been supplied with a food, a food-producing animal, or any substance intended to be, or expected to be, incorporated into a food. To this end, such operators shall have in place systems and procedures which allow for this information to be made available to the competent authorities on demand.
Food business operators must have in place systems and procedures to identify the other businesses to which their products have been supplied. This information must be made available to the competent authorities on demand. Food which is placed on the market or is likely to be placed on the market in the European Community must be adequately labelled or identified to facilitate its traceability, through relevant documentation or information in accordance with the relevant requirements of more specific provisions.
The European Commission has published a Factsheet on Traceability
Regulation (EU) No. 931/2011 sets out the traceability requirements of Regulation (EC) No 178/2002 in respect of food of animal origin. The Regulation applies to food defined as ‘unprocessed and processed products’ in Article 2(1) of Regulation (EC) No 852/2004. It does not apply to food which contain products of plant origin together with processed products of animal origin.
This Regulation places an obligation on food business operators to ensure that the following information concerning consignments of food of animal origin is made available to the food business operator to whom the food is supplied and, upon request, to the competent authority:
(a) an accurate description of the food;
(b) the volume or quantity of the food;
(c) the name and address of the food business operator from which the food has been dispatched;
(d) the name and address of the consignor (owner) if different from the food business operator from which the food has been dispatched;
(e) the name and address of the food business operator to whom the food is dispatched;
(f) the name and address of the consignee (owner), if different from the food business operator to whom the food is dispatched;
(g) a reference identifying the lot, batch or consignment, as appropriate; and
(h) the date of dispatch.
The information (a to h) must be updated on a daily basis and as a minimum be kept at least until it can be reasonably assumed that the food has been consumed.
Other principles established by the Regulation (EC) No 178/2002 include:
The Regulation establishes the principle of risk analysis and its three inter-related components i.e. risk assessment, risk management and risk communication in relation to food safety. Risk assessment shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner. Risk management shall take into account the results of risk assessment, and the opinions of EFSA as well other factors which may be legitimate to the matter under consideration.
Regulation (EC) No 178/2002 formally establishes the Precautionary Principle as an option where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures based on the precautionary principle may be made. In 2000, the European Commission issued a Communication on the Precautionary Principle. The objective of the Communication is to outline the Commission's approach to using the precautionary principle and to establish Commission guidelines for applying it.
The Regulation establishes a framework for the greater involvement of stakeholders in the development of food law and establishes that there should be open and transparent public consultation, directly or through representative bodies, during the preparation, evaluation and revision of food law (except where the urgency of the matter does not allow it).
Regulation (EC) No 178/2002 provides for different procedures in matters of food safety:
- the Rapid Alert System for Food and Feed (RASFF)
- the adoption of emergency measures
- crisis management
Rapid Alert System for Food and Feed (RASFF)
The Regulation gives legal effect to RASFF. The system deals with the obligatory notification of any direct or indirect risk to human health, animal health or the environment within a network consisting of national competent authorities, EFSA and the European Commission. The Regulation also confers special powers on the European Commission for taking emergency measures. Such measures can be taken where it is evident that feed or food originating in the EU, or imported from a third country, is likely to constitute a serious risk to human health, animal health or the environment, and that such a risk cannot be contained satisfactorily by means of measures taken by the Member States.
Where it is evident that food or feed originating in the EU or imported from a third country is likely to constitute a serious risk to human health, animal health or the environment, and when such a risk cannot be contained satisfactorily by means of measures taken by the Member States concerned, the Commission can on its own initiative or at the request of a Member State (and following the procedure set out in the Regulation), immediately adopt certain measures set out in the Regulation. Depending on the gravity of the situation, emergency measures can take the form of the suspension of the marketing or use of the feed or food in question to subjecting the use and marketing of the feed or food to special conditions
Article 55 of Regulation (EC) No 178/2002 provides that the Commission is to draw up in close collaboration with the European Food Safety Authority (‘EFSA’) and EU Member States, a general plan for crisis management in the field of safety of food and feed.
Decision (EU) 2019/300 establishes the general plan for crisis management in the field of the safety of food and feed in accordance with Article 55 of Regulation (EC) No 178/2002. The plan covers the following two types of situations:
(a) Situations requiring enhanced EU coordination; and
(b) Situations requiring the setting up of a crisis unit bringing together the EU Commission as well as relevant Member States and EU agencies.
The plan also sets out the practical procedures necessary for enhanced preparedness and for the management of incidents at EU level, including a communication strategy in accordance with the principle of transparency. The plan applies to situations involving direct or indirect risks to public health deriving from food and feed, in particular in relation to any hazard in food and feed of biological, chemical and physical nature, which are not likely to be prevented, eliminated or reduced to an acceptable level by provisions in place or cannot adequately be managed solely by way of application of emergency measures set out in Article 53 or 54 of Regulation (EC) No 178/2002.
General Food Law - Implementation Guidelines
The Commission has published a Guidance Document on the Implementation of Articles 11, 12, 16, 17, 18, 19 and 20 of Regulation EC/178/2002 on General Food Law. The document aims to assist all players in the food chain to better understand the requirements of the Regulation and to apply it correctly and in a uniform way.
The following issues are addressed in the document:
- Imports and exports (Articles 11 and 12)
- Withdrawal, recall and notification for food and feed (Articles 19 and 20) in relation to food and feed safety requirements (Articles 14 and 15)
- Responsibilities (Article 17)
- Traceability (Article 18)
The Health Acts contain enabling powers for the making of Regulations to prevent danger to the public health arising from the manufacture, distribution, importation or sale of food and for the making of compositional standards for foods which are of special importance to the public health. The Acts also give powers of entry to enforcement officers and prescribe the penalties for breaches of the Act or Regulations made under them .
Last reviewed: 11/12/2019