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General Principles of Food Law

EU Legislation

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.

Amended by

 Consolidated Version of Regulation (EC) No 178/2002   ( as at 30 June 2014)

Implemented by

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

 

National Legislation

For food businesses supervised by the Health Services Executive (HSE)
 

European Communities (General Food Law) Regulations 2007 (S.I. No. 747 of 2007)

Amended by:

  • 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)

Amended by:  

  • 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)

 

General principles

 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:

  • feed;
  • 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.

Unsafe food

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.


Traceability

 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:

Risk Analysis

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.

 

Precautionary Principle

 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.

Emergency measures

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

Crisis Management

 Regulation (EC) No 178/2002  provides for the drawing up of a general plan for crisis management in the field of food and feed safety. It also provides for the creation of a crisis unit . This crisis unit will be set up by the Commission and EFSA shall participate in the unit and provide scientific and technical assistance if necessary.

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)

National Legislation

Sale of Food & Drugs Acts 1875-1936 comprising:

  • Sale of Food & Drugs Act, 1875
  • Sale of Food & Drugs (Amendment) Act, 1879 (62 & 63 Vict. c.51)
  • Sale of Food & Drugs (Amendment) Act, 1899 (7 Edw. 7. c.21)
  • Margarine Act, 1887
  • Butter and Margarine Act, 1907
  • Sale of Food & Drugs (Milk) Act, 1935 (No. 3 of 1935)
  • Sale of Food & Drugs (Milk) Act, 1936 (No. 44 of 1936)
  • Sale of Food & Drugs (Milk) Act, 1935 (Section 2, Appointed Day) Order, 1936 (S.I. No. 78 of 1936)
  • Sale of Food & Drugs (Milk Sampling) Regulations, 1936  (S.I. No. 312 of 1936)
  • Sale of Food & Drugs (Milk Sampling) (Amendment) Regulations, 1941  (S.I. No. 246 of 1941)

These Acts protect the consumer against adulteration and fraud. The principal sections of the 1875 Act make it an offence to mix, colour, stain or powder any article of food with any ingredient or material so as to render the article injurious to health, with intent to sell the article in that state, or to sell to the prejudice of the purchaser any article of food which is not of the nature, substance and quality of the article demanded. It also makes it an offence to sell to the prejudice of the purchaser any article of food which is not of the nature, substance and quality of the article demanded by said purchaser.

While the sale of Food and Drugs Acts remains on the Statute Book many of the provisions have been overtaken by more specific legislation. For instance, the Acts laid down qualified standards for certain spirit drinks. These standards have however, been overtaken by absolute standards set by EU Directive and transposed into national legislation by the Minster for Agriculture, Food and the Marine in Regulations dealing with the description of spirit drinks.

Health Acts

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 thereunder.

Last reviewed: 13/7/2016

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