Food Business Registration

Table of Contents

Application

The Regulations do not apply to a primary producer or other food or feed business engaged in–

retail sale or supply directly to a final consumer except if the sale or supply is from an establishment registered or approved retail of fish or a fishery product (by, or on behalf of a primary producer),
primary production, domestic preparation, handling or storage for private domestic production,
the supply of fish feed for, and feeding of fish feed to, fish –kept for domestic production, or ) not kept for food production, or
marginal, localised and restricted supply of a food of animal origin from a retail establishment to another retail establishment,

to the extent that the food or feed business engages in any of these activities.

There are also certain exemptions for a primary producer engaged in –

direct supply of a primary product of fishing or aquaculture, not exceeding 30 kilogrammes per week, to the final consumer or to a local retail establishment supplying directly to the final consumer, (with respect to live bivalve molluscs this exemption applies only to live bivalve molluscs harvested from class A areas (classified by the Sea Fisheries Protection Authority in accordance with Article 53 of Commission Implementing Regulation (EU) 2019/627 of 15 March 2019) and where the area has not been closed due to excessive levels of toxin (in accordance with Article 62 of Commission Implementing Regulation (EU) 2019/627 of 15 March 2019)),
direct supply of eggs from a flock of hens (gallus gallus domesticus) or quail not exceeding 50 birds, or a flock of ducks or geese not exceeding 20 birds, to the final consumer or to retail establishments supplying directly to the final consumer, located no more than 100 kilometres from the production site,
direct supply of raw milk, not exceeding 30 litres per week, to the final consumer or to retail establishments supplying directly to the final consumer, located no more than 20 kilometres from the holding,
hunting, where the primary producer is engaged solely in the supply of wild game that he or she has hunted if –
no more than one large wild game or no more than three small wild game are supplied in a week, with a maximum of three large wild game or thirty small wild game supplied in a year, and the wild game is supplied only to final consumers, or to retail establishments that supply the final consumer, located no more than 100 kilometres from where the wild game was hunted,to the extent that the food or feed business engages in any of these activities.

The full obligations do not apply to-

a primary producer engaged in direct supply of poultry and lagomorphs, slaughtered on the holding, to the final consumer or to retail establishments supplying the meat directly to the final consumer, located no more than 100 kilometres from the holding, if no more than 1,000 birds are slaughtered in a week, with a maximum of 10,000 birds being slaughtered in a calendar year, or) no more than 1,000 animals are slaughtered in a week, with a maximum of 10,000 animals being slaughtered in a calendar year, or
the supply, by a hunter, of wild game or wild game meat to the final consumer, or to retail establishments that supply the final consumer, located no more than 100 kilometres from where the wild game was hunted, if – the meat of no more than one large wild game or no more than three small wild game is supplied in a week, and) the meat of no more than three large wild game or thirty small wild game is supplied in a year,

to the extent that the food or feed business engages in any of these activities.

Registration Requirements

A person shall not operate a food business unless his or her name, the name and address of the establishment, and the nature of the food business operated in the establishment are entered in the Register of Food Businesses” or the Register of Feed Businesses of the Official Control Register.

An application for registration in respect of a primary producer (other than a primary producer whose production relates to fishery products or to wild game), an importer or distributor of foods of animal origin who engages in the distribution of 20 tonnes or more of animal products at any one time, or a feed business shall be in a form and contain any information that the Minister may require.

A primary producer or an establishment engaged in the production, processing, distribution, export, import, or otherwise placing on the market, of fishery products not subject to Regulation 5, shall be in a form and contain information that the Sea Fisheries Protection Authority may require.

A primary producer engaged in hunting and supply of wild game shall be in a form and contain any information that the Minister for Culture, Heritage and the Gaeltacht may require. A food business engaged in the production of poultry and lagomorphs , or an importer or distributor of foods of animal origin who engages in the distribution of animal products and is not referred to above, shall be in a form and contain any information that the local authority in whose functional area the business is situated may require.

Registration Food Business HSE

An application for registration in respect of a food business to which this Regulation relates that is not referred to above and in respect of which the Health Service Executive exercised statutory functions, or is of a class or type of food business assigned to the Health Service Executive by the Food Safety Authority of Ireland’s inter-agency agreement on supervisory arrangements, shall be in a form and contain any information that the Executive may require.

An application for registration in respect of a food business to which these Regulations apply that is not otherwise specified in this Regulation shall be made to the registering authority to which the Food Safety Authority of Ireland directs the notification. A registering authority may enter the name and address of a person, the name and address of an establishment, and the nature of the food or feed business operated in the establishment in a register of food businesses or a register of feed businesses, suspend or revoke registration or refuse an application.

Deemed Registered

A primary producer who is of a class or type who may be eligible to receive a payment under the Direct Payments Regulations is considered to be entered in the register of food businesses and, where appropriate, the register of feed businesses.

A hunter who supplies wild game and is licensed by the Minister for Culture, Heritage and the Gaeltacht in accordance with Sections 28 and 29 of the Wildlife Acts 1976 to 2018 shall be considered to be entered in the register of food businesses.

If an establishment is engaged in more than one activity to which the regulation relates, and those activities would, but for this paragraph, be subject to an application to different registering authorities, the application shall be accepted by one registering authority agreed between the registering authorities concerned. A registering authority may transfer an application to another registering authority by agreement between the registering authorities.

A registering authority shall not consider an application unless it contains all the material and particulars sought by the authority and is accompanied by the fee (if any) set A person whose name is entered in a register of food businesses or a register of feed businesses shall make such returns to the Minister or registering authority as the Minister or registering authority may require.

Approval of Slaughterhouses by Council

A person shall not operate a food business other than under and in accordance with an approval granted for the purposes of those provisions (“food business approval”), or a feed business applies other than under and in accordance with an approval granted for the purposes of that provision (“feed business approval”).

An application for a food business approval in respect of

a food business engaged in the slaughter of animals where no more than 100 livestock units are slaughtered in any week with a maximum of 5,000 livestock units slaughtered in a calendar year,
a food business engaged in the slaughter of poultry where no more than 3,000 birds are slaughtered in any week with a maximum of 150,000 birds slaughtered in a calendar year,
a food business engaged in the slaughter of lagomorphs where no more than 3,000 lagomorphs are slaughtered in any week with a maximum of 150,000 lagomorphs slaughtered in a calendar year,
a food business engaged in the preparation of minced meat or mechanically separated meat where no more than 5 tonnes of minced meat and mechanically separated meat in total is produced in any week,
a food business engaged in the production of meat preparations or meat products, where no more than 20 tonnes of finished products or preparations in total are produced in any week,
a food business operating as a cutting plant where no more than 20 tonnes of fresh meat is produced in any week, or
a food business engaged in the handling of wild game where no more than 8 livestock units are handled in any week with a maximum of 200 livestock units being handled in a calendar year,

shall be in a form and contain any information that the local authority in whose functional area the business is situated may require.

Larger and Other Animal Origin

An application for a food business approval or feed business approval in respect of a food business of a class or description specified above where the amount produced is greater than the amount specified for that type of business, a food business importing or producing novel foods of animal origin, including but not limited to, reptile meat or insects intended for human consumption, a food business engaged in the production of sprouts (as defined in Regulation No 210/2013), a food business where Regulation No 853/2004, Annex III, Section IX, which refers to Raw Milk, Colostrum, Dairy Products and Colostrum-Based Products, or Regulation No 853/2004, Annex III, Section X, which refers to Eggs and Egg Products, applies, a food business engaged in the slaughter of animals not otherwise referred to in this Regulation, or a feed business, shall be in a form and contain any information that the Minister may require.

An application in respect of a food business to which Regulation No 853/2004, Annex III, Section VII, which refers to Live Bivalve Molluscs, or Regulation No 853/2004, Annex III, Section VIII, which refers to Fishery Products, applies, shall be in a form and contain any information that the Sea Fisheries Protection Authority may require.

Applications to HSE

An application for approval in respect of a food business to which this Regulation relates that is not referred to above, and in respect of which the Health Service Executive exercised statutory functions prior to the making of these Regulations, or is of a class or type of food business assigned to the Health Service Executive by the Food Safety Authority of Ireland’s inter-agency agreement on supervisory arrangements, shall be in a form and contain any information that the Executive may require.

Other Applications

An application for approval in respect of a food business establishment operating as a cold storage plant, or a food business not otherwise specified in this Regulation shall be made to the registering authority to which the Food Safety Authority of Ireland directs the application.

If an establishment is engaged in more than one activity to which this Regulation relates, or engaged in an activity to which this Regulation relates, and is, at the same time, engaged in an activity subject to the European Communities (Hygiene of Foodstuffs) Regulations 2006 (S.I. No. 369 of 2006), and those activities would, but for this paragraph, be subject to application to different registering authorities, the application may be determined by one registering authority agreed between the registering authorities concerned.

Notwithstanding the above, a registering authority may transfer an application for approval to another registering authority by agreement between the registering authorities. A registering authority shall not consider an application unless the application contains all the material and particulars sought by the authority and is accompanied by the fee (if any) set.

Approval Conditions

A registering authority may grant a food business approval or a feed business approval, attach a condition to a food business approval or a feed business approval, vary or revoke a condition, suspend or revoke a food business approval or a feed business approval or refuse an application for approval in accordance with Regulation 6.

A registering authority may, for good and sufficient reason, make a food business approval or a feed business approval valid for a limited period. A registering authority may, in respect of an application for a food business approval or a feed business approval, grant a conditional approval for up to 2 periods of not more than 3 months (or where the approval concerns a fishing vessel, conditional approval for a period of 12 months).

The holder of a food business approval or a feed business approval shall make such returns to the Minister or registering authority as the Minister or registering authority may require. In this Regulation: 1 livestock unit is the equivalent of an adult bovine animal with a live weight of 300 kg or more; 0.5 livestock units is the equivalent of a reptile or a bovine other than a bovine referred to above; 0.2 livestock units is the equivalent of a pig with a live weight of 100 kg or more or a large game (including deer) with a live weight of 100 kg or more; 0.15 livestock units is the equivalent of a pig other than a pig referred to above; 0.1 livestock units is the equivalent of a ratite; 0.05 livestock units is the equivalent of a sheep or goat, or a deer other than a deer referred to above.

Suspension or Revocation

Without prejudice to the generality of the above, a registering authority may, in respect of an application or registration made under the mentioned regulation, refuse to accept an application from a food business operator or a feed business operator for registration if it is satisfied that information required has not been furnished or information that is false or misleading in a material respect has been furnished, or remove from a register a food business operator or a feed business operator, if it is satisfied that a registered person has ceased to carry out the activity to which the registration relates on the premises to which the registration relates.

If a registering authority proposes to refuse an application or to revoke a registration, it shall notify the applicant or registered food business operator or feed business operator of the proposal and the reasons for the proposal, and that he or she may make representations in relation to the proposal to the registering authority within 14 days of notification, consider a representation duly made before deciding whether to proceed with, modify or annul the proposal, and notify the applicant or registered person of the decision and the reasons for the decision.

Grounds for Suspension

A registering authority may refuse an application or suspend or revoke a food business approval or feed business approval if it is satisfied

that an act of the institutions of the European Union or these Regulations have not, are not or will not be, complied with, the applicant or holder of a food business approval or a feed business approval has contravened a provision of an enactment, whether he or she has been convicted or not, relating to food, feed, animal or public health, animal welfare or the environment,
the applicant or holder of a food business approval or a feed business approval has failed to comply with a condition of a food business approval or a feed business approval, in relation to an application, information required has not been furnished or information that is false or misleading in a material respect has been furnished,
the premises to which the application or food business approval or a feed business approval relates is not, or has ceased to be, a premises that meets the structural, operational and hygiene requirements of the European legislation on food and feed relevant to the form of premises to be approved,
the applicant or holder of a food business approval or a feed business approval is not a fit and proper person to be approved,
the holder of a food business approval or a feed business approval has ceased to carry out the activity to which approval relates at the premises to which approval relates,
the applicant or registered person, having been given 28 days to do so, fails to pay a fee under Regulation 20, it is necessary for the protection of human health, animal health or welfare or the environment, including the prevention, control or eradication of a disease, or it is necessary, ancillary or supplementary for an act of the institutions of the European Union to have full effect.

Suspension Procedure

Other than in the case of the specific provisions, if a registering authority proposes to refuse an application or to suspend or revoke an approval, it shall notify the applicant or holder of the food business approval or feed business approval of the proposal and the reasons for the proposal, and that he or she may make representations in relation to the proposal to the registering authority within 14 days of notification, consider a representation duly made before deciding whether to proceed with, modify or annul the proposal, and notify the applicant or registered person of the decision and the reasons for the decision.

If a registering authority is of the opinion that it is necessary for the protection of human health, animal health or welfare or the environment, including the prevention, control or eradication of a disease, or it is necessary, ancillary or supplementary for an act of the institutions of the European Union to have full effect, it may refuse an application, suspend or revoke an approval in accordance with the following paragraph.

If a registering authority refuses an application or suspends or revokes an approval in accordance with this paragraph, it shall notify the applicant or registered person of the decision and the reasons for the decision, and that he or she may make representations in relation to the decision to the registering authority within 14 days of notification, consider a representation made, and confirm, modify or annul the decision and notify the applicant or holder of the authorisation of the decision and the reasons for the decision.

If a registering authority suspends a food business approval or a feed business approval, the approval and the entry in the register of food businesses or register of feed businesses relating to the person and establishment suspended has no effect for the duration of the suspension, or revokes a food business approval or a feed business approval or the approval expires by effluxion of time, the approval and the entry in the register of food businesses or feed businesses relating to the person to whom, and establishment to which, approval formerly related has no effect.

Certificate of approval

If a registering authority grants a feed business approval or a food business approval, it shall issue a certificate to the holder of the feed business approval or food business approval (“certificate of approval”).

A certificate of approval shall contain-

the name of the holder of the feed business approval or food business approval,
the address of the premises to which the feed business approval or food business approval relates,
the nature of the activity to which the feed business approval or food business approval relates,
the conditions to which the feed business approval or food business approval is subject,
the period of validity (if any) of the feed business approval or food business approval,
a unique reference number that identifies the feed business or food business, and
the name of the registering authority.

If a feed business approval or food business approval is suspended or revoked, the holder of the certificate of approval shall surrender it on request to the registering authority or an authorised officer.

If a certificate of approval is surrendered to a registering authority or an authorised officer, the authority or officer shall return it to the holder on expiry of a period of suspension.

The holder of a feed business approval or a food business approval shall cause the certificate of approval to be displayed prominently on the premises to which the approval relates during business hours.

Maintenance of register, etc

The Food Safety Authority of Ireland shall maintain and publish, in a manner that the Authority considers appropriate, the register of approved food businesses on the basis of information furnished by registering authorities.

The Minister for Agriculture shall maintain and publish, in a manner that he or she considers appropriate— the register of feed businesses and a list of feed business approvals.