Business Start-up Information

The information contained within this factsheet aims to provide general guidelines for those involved in setting up a food business. It outlines initial steps to be followed as well as a brief description of legislation. However, the responsibility lies with the individual food business operator to determine how the Regulations apply in practice to them, as this document is not an interpretation of the law.

A food business is defined as ‘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.’

Three Steps to Your New Food Business

1. Know the Legislation

All food business operators must comply with Regulation 852/2004/EC on the hygiene of foodstuffs.

This Regulation sets out the legal requirements in relation to food hygiene and places primary responsibility for food safety with the food business operator.

It requires the implementation of procedures based on HACCP (Hazard Analysis and Critical Control Points) principles, together with the application of good hygiene practice.

It sets out general requirements for all food business operators in Article 4, as well as more specific requirements, in Annex II. These include, among others, requirements for layout, construction etc. of food premises, transport, equipment, water supply, food waste and personal hygiene.

The Regulation requires that all food business operators must register with or seek approval from a competent authority. Compliance with the Regulation will be assessed by the competent authority and your business may be inspected at any time to check for compliance.

It also places the onus on the proprietor to ensure food handlers are supervised and instructed and/or trained in food hygiene matters commensurate with their work activity.

Food businesses handling food of animal origin

Food businesses handling or processing foods of animal origin may also need to comply with Regulation
853/2004/EC laying down specific rules for foods of animal origin.

These types of businesses must register with, and may also require approval by the Department of Agriculture,
Food and the Marine, the local authority veterinary service, the Sea-Fisheries Protection Authority
or the Health Service Executive depending on the type of business (See Step 2 – Registration or Approval).
Products that come under this legislation must carry a health or identification mark, indicating
the approval number of the establishment and the code for the Member State where the establishment
is located, e.g.

Traceability and recall

Regulation 178/2002/EC requires food businesses to have a traceability system in place that allows them
to trace one step forward and one step back (note: in the case of sale to the final consumer, food business
operators need only trace one step back). In addition, in the event of unsafe food being placed on the market,
the food business must recall or withdraw the food.

Additional legislation

Compliance with additional legislation may be required depending on the type of product, e.g. labelling, additives,
food supplements, marketing standards for eggs, nutrition and health claims, etc.

All of the legislation outlined is available on our website at: http://www.fsai.ie/legislation/food_legislation.html

2. Registration or Approval

A person proposing to operate a food business is legally obliged to register with or seek approval from a
competent authority prior to commencement of trade, and failure to do so is an offence. The competent authority will depend on the nature of the business and whether foods of animal origin, e.g. meat, poultry, fish etc. are handled or processed.

If your business handles and/or processes foods of animal origin, you may need approval from the competent
authority. Details of the approval process are available from the competent authority.

Competent authorities

• Health Service Executive (HSE)
  Typically, the HSE inspects businesses such as restaurants, delis, retailers, mobile food businesses, food stalls, some manufacturing premises and food businesses operating from home.
  • Contact your local HSE office (link opens in a new window) for further information.
• Department of Agriculture, Food and the Marine (DAFM)
  Typically, DAFM inspects establishments involved in animal slaughter and handling and/or processing meat, dairy products, eggs etc.
  • Lo Call DAFM at 1890 200510 or telephone 01 6072000
• Sea-Fisheries Protection Authority (SFPA)
  Typically, the SFPA inspects establishments that handle and/or process fish and fishery products and products of aquaculture.
  • Phone the SFPA on 021 4515100

3. Obtain a Copy of the Relevant National Standards Authority of Ireland (NSAI) Guidelines

The NSAI has published a series of standards that provide guidance to compliance with Regulation 852/2004/EC on the hygiene of foodstuffs.

The NSAI guides may be purchased from:

• National Standards Authority of Ireland, I.L.I. Standard Distributors, 42-44 Northumberland Road, Ballsbridge, Dublin 4.
  Tel: (01) 8576730/8576731 Fax: (01) 8576729

I.S. 340:2007 “Hygiene in the Catering Sector”

Applies to all catering premises where food is prepared and served to customers and includes restaurants,
hotels, canteens, fast food outlets, cafes and licensed premises. Its essential features include:

• Registration, traceability and recall
• The requirements that must be met by caterers to ensure that the storage, preparation, handling and where applicable, transportation and distribution of food is carried out in a hygienic way
• Maintenance of the cold chain
• Application of HACCP principles

I.S. 341:2007 “Hygiene in Food Retailing and Wholesaling”

This applies to food businesses that operate in the food retail sector and includes independent and multiple
retailers, service stations and other retailers of food to consumers. It contains information on:

• Registration
• Traceability
• Personnel hygiene requirements
• Premises and equipment requirements
• Control of food safety hazards

I.S. 22000:2005 “Food Safety Management incorporating HACCP”

Specifies requirements for a food safety management system that combines the following generally recognised
key elements to ensure food safety along the food chain up to the point of final consumption:

• Interactive communication
• System management
• Prerequisite programmes
• HACCP principles

Other useful FSAI publications

The FSAI has produced a number of publications which are useful for new businesses:

• Guidance Note No. 10 – Product Recall and Traceability (Revision 3)
• Guidance Note No. 11 – Assessment of HACCP Compliance (Revision 2)
• Guidance Note No. 16 – Food Stalls (Revision 2)
• Guidance Note No. 18 – Validation of Product Shelf-Life (Revision 2)
• Guidance Note No. 26 – Guidance for Food Business Operators on the Implementation of legislation on Microbiological Criteria for Foodstuffs
• Guidance Note No. 27 – Enforcement of Commission Regulation (EC) No 2073/2005 on Microbiological Criteria for Foodstuffs
• Guidance Note No. 28 – Food Allergen Information for Non-Prepacked Foods in Ireland
• Safe Catering Pack (an aid to the implementation of HACCP) - €60 (plus €10 post & packaging)
• Food Safety Training – A legal requirement for everyone in the food industry
• Guide to Food Safety Training Level 1 & 2 (Induction and additional skills) and Level 3 (For managers)
• Starting a Food Business in the Home
• Guide to Food Law for Artisan and Small Food Producers Starting a New Business
• Country Markets’ Guide to Good Hygiene Practice
• Food Information on Prepacked Foods
• Allergen Information for Non-Prepacked Foods

These publications (with the exception of the Safe Catering Pack) are available to download free of charge from our publications section. The Safe Catering Pack can be purchased online for €70
(Safe Catering Pack – €60; Delivery – €10).

Useful websites

The following websites may provide additional information for food businesses:

1. Ashtown Food Research Centre www.teagasc.ie
2. Associated Craft Butchers of Ireland www.craftbutchers.ie
3. Bord Bia www.bordbia.ie
4. Caís (the Association of Irish Farmhouse Cheese makers) www.irishcheese.ie
5. Enterprise Ireland www.enterprise-ireland.com
6. Excellence Ireland www.eiqa.com
7. Irish Village Markets www.irishvillagemarkets.ie
8. Irish Organic Farmers and Growers Association www.iofga.org
9. National Hygiene Partnership www.nhp.ie
10. National Accreditation Board www.inab.ie

If you have any more questions you can contact our Advice Line.

Print