 |
 | Item from Issue 7 eNewsletter |  |
<- back to Issue 7 eNewsletter
<- back to eNewsletter index
EU Hygiene Package strengthens consumer protection
Introduction Click here to view diagram
The ‘Hygiene Package’ is a term that refers to a group of European Regulations that came into force across the EU on 1st January 2006, which represent a significant reorganisation of the regulatory framework for food hygiene and safety. This package builds on the general food law basis established by Regulation (EC) 178/2002 to realise the broad strategy outlined in the Commission’s White Paper on Food Safety in 2000
In general terms, the new regulations provide a holistic approach to safety assurance across the entire food chain from primary production inputs, through to point of supply to the final consumer. A salient underlying theme is that responsibility for food safety assurance rests with the food business operator (FBO). In this regard, the role of Competent Authorities such as the Department of Agriculture and Food (DAF), Department of Communications, Marine and Natural Resources (DCMNR), the Health Service Executive (HSE), and the various Local Authorities (LAs) is to verify compliance by the FBO.
General Food Law Regulation 178/2002
This regulation lays down general principles and requirements of food law. Food may only be placed on the market if it is safe; and FBOs are required to have systems in place to remove food from the market if it is unsafe. This regulation ascribes a risk-based approach to food safety assurance. Traceabilility of food becomes a requirement of all FBOs with direct relevance to withdrawals or recalls of unsafe food. This regulation also established the European Food Safety Authority; and created requirements for a Rapid Alert System for Food and Feed, to permit prompt action in dealing with issues affecting food distributed across different Member States. In Ireland, the RASFF function is coordinated by the FSAI.
‘Hygiene 1’ Regulation 852/2004
This regulation lays down basic hygiene requirements for all food business operations throughout the food chain. An approach to food safety assurance based upon HACCP principles is required from all FBOs after primary production, with provision for adaptation according to the size and nature of the operation. Compliance with temperature controls and microbiological criteria is required where appropriate. This regulation requires establishments involved in a food business operation to be registered with a Competent Authority. Sector specific hygiene requirements are stipulated in the annexes of this regulation. Whilst this regulation pertains to all FBOs, it represents the extent of requirements for retail food business operations.
‘Hygiene 2’ Regulation 853/2004
This regulation provides additional requirements regarding hygiene and safety assurance for FBOs involved in production and placing on the market of foods of animal origin, such as slaughterhouses, cutting plants or meat wholesalers. With the exception of retail activity, food of animal origin may only be placed on the market from establishments that have been approved according to the requirements of this regulation. In Ireland, DAF, DCMNR, HSE, and the various LA’s are responsible for approval. Establishments are required to meet the sector-specific structural and operational requirements described in the annexes prior to approval. Approved establishments are issued with an approval number, which forms part of a health mark they apply to carcasses, or an identification mark incorporated in their packaging and documentation systems. Products from approved plants may be traded throughout the European community without restrictions provided it is accompanied by appropriate commercial documentation. The FSAI maintains the Irish central register of approved establishments, while the European Commission provides links to the register of each member state.
‘Hygiene 3’ Regulation 854/2005
This regulation provides additional official control requirements for establishments producing foods of animal origin, e.g. meat, milk and fish. Whilst regulation 853/2004 describes the obligations of FBOs at these establishments, this regulation prescribes the nature of official controls required at such establishments. Sector-specific requirements are described in the various annexes, e.g. ante- and post-mortem examination at slaughterhouses and game handling establishments; monitoring of shellfish production areas and hygiene assurance for fishery products; and inspection of dairy production holdings and raw milk.
‘Hygiene 4’ Directive 2002/99 and ‘Hygiene 5’ Directive 2004/41
Directive 2002/99 represents a legislative consolidation of animal health rules for production of food of animal origin. Directive 2004/41 repealed previous food hygiene and safety legislation now superceded by the Regulations 852, 853 and 854 of 2004.
Microbiological Criteria Regulation 2073/2005
This regulation creates a requirement for all FBOs to have sampling in place to demonstrate their compliance with prescribed microbiological criteria, in a manner commensurate to the nature and size of their business. The regulation separates process hygiene criteria from food safety criteria. Trends in quantitative counts of indicator microorganisms are required as indices of acceptable production hygiene. Unsatisfactory results require improvements in process hygiene. Food safety criteria are stipulated for various products, with maximal quantitative loads or quantitative presence of indicator pathogens such as or Listeria or Salmonella stipulated during the shelf-life of the products. Unsatisfactory food safety results require withdrawal and/or recall of affected batches.
Trichinella Regulation Regulation 2075/2005
Regulation 2075/2005 creates a requirement for all pigs slaughtered for human consumption to be screened for trichinellossis. This regulation creates provision for member states to have substantially reduced sampling, where justified with evidence of freedom from, or negligible levels of Trichinella.
Implementing Measures Regulation 2074/2005
and Transitional Arrangements Regulation 2076/2005
Regulation 2074/2005 provides a set of implementing measures some of which develop and clarify various requirements of the primary regulations, e.g. information flow between slaughterhouses and holding of provenance. Regulation 2076/2005 defines the period from 1st January 2006 to 31st Dec 2009 as a transitional period during which various exemptions from the provisions of the hygiene package are permissible.
Official Controls Regulation 882/2004
Regulation 882/2004 stipulates the obligations of Member States to carry out official controls to verify compliance of FBOs with the requirements of the food and feed regulations. Official controls should be carried out regularly, on a risk basis with appropriate frequency; and should utilise approaches such as monitoring, surveillance, verification, audit, inspection, sampling, and analysis. Official controls for food and feed from third countries are also stipulated. Member states can collect fees from the FBOs to recover costs associated with official controls.
National Legislation
In Ireland, official agencies have been endowed with enforcement powers, e.g. right of entry and prosecution, by transposition of these regulations onto the Irish Statute Books.
The Hygiene package framework recognises that for some food business operations, a generic EU-wide approach would not be appropriate, and provision is made for national rules taking into account local national considerations.
Implementation and effects to date
The approach to implementing the hygiene package by Irish Competent Authorities has been pragmatic and reasoned. Much of the change has, in fact, been in the structure of the regulatory framework, and many of the requirements for FBOs have remained relatively consistent with pre-existing regulatory requirements. Thus, the changes for FBOs on the ground have generally been evolutionary rather than revolutionary. The shift in responsibility onto the FBO, with consequent alteration of the role of the supervising Competent Authority, requires a significant, proactive, and necessarily gradual alteration of attitude by all concerned.
Further Information
Micheál O’ Mahony
Chief Specialist, Veterinary Public Health
Food Safety Authority of Ireland
Abbey Court
Lower Abbey Street
Dublin 1
Tel: 01 8171300
email: momahony@fsai.ie
<- back to Issue 7 eNewsletter
<- back to eNewsletter index
|
HOME
SITE MAP
