Overview of the Food Safety Authority of Ireland (FSAI)
Organisational structure of the FSAI
The Food Safety Authority of Ireland (FSAI) is the central competent authority in Ireland, with overall responsibility for the enforcement of food legislation. The FSAI was established under the Food Safety Authority of Ireland Act, 1998 and its mission is to protect consumers and raise compliance through partnership, science and food law enforcement.
The organisational chart above outlines the organisational structure of the FSAI. The Department of Health is the parent department of the FSAI. Two independent bodies, the Scientific Committee and Consultative Council, advise the Board, which the Chief Executive Officer (CEO) reports directly into. The CEO is responsible for the day-to-day running of the Authority as well as for providing leadership among her peers in food safety agencies across Europe and beyond. The Communications team, Import Controls and Public Health Nutrition Policy team report directly into the CEO. The CEO is supported by the Senior Leadership Team, which oversees operations within the Authority’s five functional areas:
- Corporate Affairs – Provide corporate services (e.g., finance, human resources, information technology, data management, etc.) to the FSAI.
- Enforcement Policy – Ensure the enforcement of food legislation through the management of the service contracts with the Authority’s official agencies, liaison with SANTE F for audits relating to food safety, development and publication of Ireland’s Multi-Annual National Control Plan (MANCP) and co-ordination of competent authorities.
- Audit, Incidents and Investigations – Conduct audits, investigate protected disclosures and food fraud and manage food incidents. This functional area is the national contact point for the Rapid Alert System for Food & Feed (RASFF) and the Administrative Assistance and Cooperation Programme (AAC).
- Regulatory Affairs and Compliance Building – Provide technical support in the areas of environmental health, veterinary public health and agriculture and training and compliance.
- Food Science and Standards – Provide a scientific base to support enforcement and compliance activities.
The FSAI reports to the Minister for Health and liaises with the Department of Health (DOH) and the Department of Agriculture, Food and Marine (DAFM) with respect to legislation and policy.
Areas of official controls as defined by Art 1(2) of Regulation (EU) 2017/625
Article 1(2)(a) Food contact materials
Article 1(2)(b) Genetically Modified Organisms (GMOs)
Article 1(2)(i) Organic production and labelling of organic products
Article 1(2)(j) Protected designations of origin (PDOs), protected geographical indications (PGIs), traditional specialities guaranteed (TSGs)
Delegation of offical controls
The SFPA do not delegate any official control tasks to delegated bodies in accordance with Article 28 of Regulation (EU) 2017/625.
Scope of responsibility of the FSAI for the official control of food
The FSAI is directly involved in several types of control activities including audits, inspections, certification (food contact materials for export), permitting/ assessment/authorisations, investigation of food incidents and alerts and monitoring and surveillance. As a priority, controls are targeted at areas of non-compliance or where there are suspected non-compliances.
17/625 Enforcement of legislation
The responsibility for enforcement of food legislation is managed through contractual arrangements (Service Contracts) between the FSAI and a number of competent authorities involved in the enforcement of food legislation. Each competent authority provides the FSAI with an annual service plan which outlines the planned official controls for the year. Further information in the FSAI’s relationship with these competent authorities is provided here.
The FSAI is responsible for co-ordination of food control activities within and between competent authorities, determining inter-agency supervisory arrangements and ensuring consistency of enforcement. This is achieved through:
- Management of the official control activities through the service contract arrangements
- Carrying out risk assessment to underpin risk management decisions/actions
- The provision of scientific and technical support to competent authorities through publications and training programmes
In addition, the FSAI is also responsible for:
- Defining supervisory arrangements
- Organising and providing technical and scientific input to monitoring and surveillance programmes
- Compiling, analysing and managing data relating to official food controls. National data are used to monitor and evaluate official control systems, as a basis for risk assessment and to prepare reports to the Commission and the European Food Safety Authority (EFSA).
- Issuing permits for irradiation facilities to irradiate foodstuffs
- Promoting and contributing to the development of food quality assurance schemes
- Carrying out the initial assessment of novel foods
- Undertaking the initial assessment of genetically modified food applications
- Processing the notifications of new food supplements
- Processing the notification of foods for particular nutritional uses
- Processing the notification of foods for special medical purposes
- Processing the applications for evaluations of substances and processes for food contact.
FSAI strategy and goals
The FSAI Strategy 2019 - 2023 is published on the FSAI website. The strategy document outline’s the FSAI’s goals:
- Enforcement & compliance
- Science, expertise & evidence
- Engagement & communication
- Organisational excellence.
The official agencies of the FSAI are responsible for conducting official controls in Ireland. As the central competent authority, the FSAI oversees and supports these official controls in a number of ways.
Audit and investigations
The mission, role and objectives of the FSAI audit function are documented in its Audit Charter.
In accordance with its mandate, the FSAI carries out the following types of audits
- Audits of official controls - The statutory basis for these audits is contained in Section 48(9) of the FSAI Act, 1998. The procedures and processes governing the way the FSAI carry out audits of the competent authorities are set out in Schedule 5 of each of the service contracts.
- Targeted or focused audits - To examine compliance with specific pieces of EU and/or national legislation.
- Special investigations - The FSAI may also conduct special investigations in conjunction with competent authorities where serious breaches of food law or food fraud have been detected.
- Santé F close-out audits - Carried out, where necessary, to examine and update the corrective actions taken to address findings from Santé F missions and to verify their closure/current state of compliance.
- Third country audits - The FSAI assists third country auditors in their assessment of the food safety standards achieved by the Irish food industry.
Further information on FSAI audits can be found on the FSAI website.
National control plans
The FSAI co-ordinates a national microbiological surveillance programme in conjunction with the environmental health service (EHS) and official food microbiological laboratories (OFMLs) in the Health Service Executive (HSE). This involves selecting relevant topics on an annual basis. The FSAI prepares a sampling protocol, prepares a questionnaire to collect information at the time of sampling, compiles the sample and test data and produces a report on the findings of these surveys.
The FSAI is responsible for the organisation of the surveillance activities required by European Union (EU) co-ordinated control plans. This involves participating in EU working group meetings to decide on the topics for these plans and advising the relevant competent authorities of the sampling and analytical requirements. The FSAI is also responsible for the compilation of the sample and test data and sending reports on same to the Commission.
The FSAI also organises and carries out a number of monitoring and surveillance programmes, such as:
- National surveys, e.g., to detect genetically modified foods/food components, irradiated foods/food components, composition of food supplements, compliance with labelling requirements of food and food contact materials.
- Specialist surveys of chemicals in food, i.e., additives or contaminants, e.g., persistent organic pollutants. Where monitoring is required and the capability/capacity for analysis is not available within the official laboratories, the FSAI organises specialist surveys using external laboratories.
- Topical surveys are arranged to obtain information on areas where the FSAI are working with industry to achieve gradual, sustained and universal improvements, e.g., salt, prevalence of non-O157 Verotoxigenic Escherichia coli in Irish minced beef.
The Food Safety Authority of Ireland Act, 1998 contains enforcement provisions which are in addition to the powers to prosecute and other provisions on specific pieces of food legislation. The provisions in the FSAI Act are designed to provide an improved means of reacting to and dealing with situations posing a risk to public health. Enforcement is carried out by authorised officers appointed by the FSAI or its official agents under Section 49 of the FSAI Act. The powers granted to these officers are detailed in Sections 50 and 51 of the FSAI Act. These enforcement tools provide an alternative to a strictly punitive response to non-compliance and create an environment for compliance building.
Further details on enforcement powers are available here.
EU rapid alert system for food and feed (RASFF)
The FSAI is the co-ordinating body for food alerts and the contact point for the EU RASFF system in Ireland. Food incidents are investigated by the competent authorities in accordance with Code of Practice No.5 - Food Incidents and Food Alerts. Local incidents will normally be investigated by one competent authority, but for those with a wider impact, the FSAI acts as a central contact point for gathering and issuing information from and to the competent authorities involved. The FSAI also provides support to the investigating competent authorities by providing information and scientific advice during the investigation and by contributing to the risk analysis process. The FSAI is responsible for the issue of national food alert and notifications from RASFF.
The FSAI chairs working groups with each of the competent authorities to progress issues in relation to official control of food specific to the competent authority. In addition, the FSAI also chairs inter-agency working groups to discuss areas where a number of competent authorities are involved.
The FSAI’s role includes the provision of a national data management service to collect and collate the official food control data. Each of the competent authorities maintains data on establishments, inspections, samples and analysis. The FSAI’s Data Management Group works closely with the competent authorities to ensure that data sets are routinely collected and standard approaches to data management are adopted. The FSAI develops and maintains data management systems for the collection, quality assurance, analysis and interpretation of data. This national data are used to monitor and evaluate official control systems, as a basis for risk assessment and to prepare reports to the Commission and the European Food Safety Authority (EFSA). In carrying out this work, the FSAI Data Management Group collaborates with EFSA and Eurostat.
Resources and Facilities
In support of the competent authority personnel, the FSAI has specialist staff with expertise in a wide variety of areas who can participate in and advise on official controls where necessary. Staffing figures are reported annually in the MANCP report. In addition, a number of FSAI staff are authorised under the FSAI Act, 1998 to enforce food legislation.
When necessary, the FSAI uses accredited designated official laboratories for the analysis of official control samples.
The FSAI has a number of specialist IT resources, including:
- Safety Net, an extranet service for sharing information with official food control staff in the competent authorities.
- Databases to record establishments, inspections, sample and laboratory results data from the competent authorities.
- Enforcements database to record enforcements under the FSAI Act and for their publication on the enforcements section of the FSAI website.
- E-commerce section of the FSAI website, which facilitates purchasing of publications, online registration for seminars etc.
The FSAI has a specialist training unit, which provides needs-based professional development training programmes to both the competent authorities and industry, to ensure consistent interpretation and application of legislation. Types of training methods used include in-person training sessions, online workshops an eLearning moduleswhich are available on the FSAI website. The training unit also uses contract trainers for certain industry programmes.
FSAI headquarters (HQ) is in central Dublin.
Regulation (EU) 2017/625 (General Obligations)
Article 5(1)(a) Effectiveness and appropriateness of official controls
The FSAI Enforcement Policy team have regular liaison meetings with the official agencies responsible for conducting official controls to ensure that official controls are appropriate and effective. The FSAI audit team also plays a role in examining the effectiveness and appropriateness of official controls through the various types of audit activities outlined above.
Article 5(1)(b) Consistency in the delivery of official controls
During liaison meetings official agencies provide updates on staff training to ensure consistency in the delivery of official controls.
The FSAI delivers needs-based professional development training programmes for officials in the competent authorities to ensure consistent interpretation and application of legislation. In addition, FSAI Guidance Note 12 – The Inspection of Food Safety Training and Competence allows for a consistent approach by competent authorities to the inspection of the training and competence of staff dealing with food and the provision of advice to food businesses in relation to staff training.
The FSAI audit team also plays a role in examining the consistency of official controls through the various types of audit activities outlined above. Official control data, supplied to the FSAI under section 48(8) of the FSAI Act, 1998, is also reviewed and can be compared between years to identify any inconsistencies in official controls.
Article 5(1)(c) Ensuring staff performing official controls are free from conflicts of interest
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Article 5(1)(d) Access to adequate laboratory capacity
Ireland has designated National Reference Laboratories (NRL) and Official Laboratories for official controls under Regulation (EU) No. 2017/625. FSAI as the central competent authority responsible for the enforcement of food legislation has service contracts with all the relevant Competent Authorities/Official Agencies responsible for the provision of NRL and Official Laboratory services.
Further information can be found on the FSAI website.
Article 5(1)(e) Access to suitably qualified and experienced staff
For new staff, competency needs are outlined with the job descriptions. Appropriate qualifications, along with the provision of any required training, and experience, provide the competence required for each position.
The FSAI operates a formal system to ensure that all staff are adequately trained to enable them to perform their assigned duties, via the performance management and development system (PMDS). Competency needs are assessed during PMDS meetings.
Staff training records are maintained to demonstrate competency and experience. The HR Department maintains and reviews the training records.
Article 5(1)(f) Access to adequate facilities and equipment
See Resources and Facilities section.
Article 5(1)(g) Ensuring staff have adequate legal powers to perform official controls
The Food Safety Authority of Ireland Act, 1998 contains enforcement provisions which are in addition to the powers to prosecute and other provisions on specific pieces of food legislation. The provisions in the FSAI Act, 1998 provide a means of reacting to and dealing with situations posing a risk to public health.
Enforcement is carried out by authorised officers appointed by the FSAI under Section 49 of the FSAI Act. The powers granted to these officers are detailed in Sections 50 and 51 of the FSAI Act.
Article 5(1)(h) Ensuring food business operators cooperate with staff performing official controls
The FSAI has extensive enforcement powers under the FSAI Act 1998, in the event of an operator not co-operating the appropriate enforcement would be taken.
Article 5(1)(i) Contingency planning
Relationships, Memoranda of Understanding and Service Level Agreements with other Competent Authorities
The FSAI is the central competent authority for the control of food and is responsible for the enforcement of all food legislation in Ireland. The FSAI carries out this enforcement function through Service Contracts with official agencies. Section 48 of the FSAI Act, 1998 gives the legislative basis for this. These contracts outline an agreed level and standard of food safety activity that the agencies perform as agents of the FSAI.
The official agencies with whom the FSAI has contracts are:
- The Health Service Executive (HSE)
- The Department of Agriculture, Food and Marine (DAFM)
- The local authorities (LAs)
- The Marine Institute (MI)
- The National Standards Authority of Ireland (NSAI)
- The Sea Fisheries Protection Authority (SFPA)
- The State Laboratory
Service contracts are a legal agreement to enforce food safety legislation drawn up in line with Section 48 of the FSAI Act, 1998 and aim to ensure the:
- Effective and consistent enforcement of food law through a risk-based approach and
- Accountability of each competent authority in enforcing food legislation through a combination of:
- Setting targets in agreed service contracts
- Providing guidance on technical aspects of implementing official food controls
- Monitoring the delivery of the service contracts
- Analysing and reporting on data provided by competent authorities
- Conducting audits of service delivery and ensuring that where necessary, corrective action is taken
The contracts are for a minimum duration of three years and subject to the request of either the FSAI or the official agency may be reviewed during that time. The contracts must be published within 3 months of the date they are entered into.
There are also Memorandums of Understanding (MoU) in place between the FSAI and other enforcement agencies. A Memorandum of Understanding sets out a framework for co-operation between the FSAI and other agencies in their food safety activities.
The agencies with whom the FSAI have MoUs with are:
- An Bord Iascaigh Mhara (BIM)
- The Environmental Protection Agency (EPA)
- The Food Standards Agency, Northern Ireland (FSA NI)
- The Health Products Regulatory Authority (HPRA)
- The Lough’s Agency
- Revenue’s Customs Service
The FSAI have the following measures in place to ensure effective and efficient communication:
- Within the FSAI
- OurSpace – an internal communications portal accessible to all staff
- Publication of the Senior Leadership Team meeting minutes on OurSpace
- Quarterly All Staff meetings, chaired by the CEO
- Regular project briefings provided by staff
- Back to office reports
- Email, video-conferencing and instant messaging software available to all staff
- With the official agencies and MoU agencies
- Formal communication:
- Regular liaison meetings between the enforcement policy team and the official agencies
- Workshops and training sessions with the official agences
- Cross-agency meetings between multiple official agencies
- Industry Fora meetings
- Working groups
- Collaboration in development of guidance documents
- Semi-formal communication:
- Regular email contact
- Informal communication:
- Phone calls
- With consumers, food businesses and external bodies
- Advice line service available
- FSAI website and social media
- Breakfast bite series
- Press releases
- Food incident and allergen alerts
Availability of documented procedures to SFPA Staff
The FSAI’s Business Management System includes the documented information that is required to be maintained and retained by ISO 9001, and additionally, any documented information that FSAI has decided is necessary in to carry out its activities.
Availability of documented procedures to the Auditors
Prior to and during an audit, documented procedures are made available to the auditors. Documentation is supplied to the Commission as requested, for example, in advance of Santé F audits.
Reviewing & updating procedures
A document control system is in place to ensure that all documents have a unique document code, version number and issue date. There is a specific procedure in place for the modification and approval of documents prior to issue. FSAI staff are informed of new documents and updated versions of existing documents by email.
The FSAI’s internal audit programme is outlines in the FSAI’s quality manual, which is available on the BMS.
The internal audit programme is prepared and agreed with the Audit and Risk Committee of the Board and is based upon a strategy that considers the status and importance of each process the compromises the scope of the BMS and organisational risk. Internal audits are conducted at planned intervals to determine whether the BMS conforms to the FSAI’s planned arrangements, meets regulatory requirements, ensures good governance and meets the requirements of ISO 9001.
The FSAI are subject to external audit by several bodies including, the European Commission (Santé F), the United States Food and Drug Administration and other third countries. The FSAI are also subject to audit by the NSAI for ISO 9001:2015 accreditation.
The FSAI’s Food Fraud Task Force is a multi-agency group which is chaired by the FSAI. The role of this Task Force is to act as a communications, coordination and networking group where intelligence and research can be shared at national and international level. Issues that are considered include raising awareness, improving mechanisms for monitoring and surveillance and training of enforcement officers.
The FSAI, food industry and consumers
The FSAI aims to assist industry to achieve good hygiene standards and comply with the law. To achieve this goal, the FSAI has a number of mechanisms for consulting with industry.
The Food Safety Consultative Council provides a forum for stakeholders (including consumers and industry) to feed in to the food safety agenda.
In addition, the FSAI has established specific Industry Fora to allow competitors from a sector of the food industry to come together in a non-competitive arena to discuss food safety issues with the FSAI and advance best hygienic practice in their sector. Currently, there are four FSAI industry forums in place:
These forums meet with the FSAI two to three times a year and discuss items such as impending food legislation and the approaches taken to food safety.
Guidance for industry
The FSAI provides training initiatives and guides for industry to create an environment for fostering compliance. The FSAI believes that guidance notes have a major role to play in assisting the food industry and regulators in Ireland, to achieve a high degree of compliance with legislation and with good practice generally. Industry guidance notes can be accessed via the publications section on the FSAI website.
Access to legislation
National and European legislation is available to competent authorities, food business operators and consumers through the legislation section of the FSAI website. Similarly, guidance for industry and enforcement staff is available to all stakeholders through the FSAI’s Advice Line, the FSAI website or as hardcopy documents from the FSAI publication’s office.
The FSAI facilitates a public consultation process on proposals on new legislation relevant to food safety. This allows for those who may be affected by proposed changes to food safety legislation or who have an interest in the legislation, to contribute their views. Occasionally, the FSAI consults with the public on FSAI documents such as draft guidance notes or codes of practice. Details of all consultations are available on the consultations section of the FSAI website.
Quality Assurance Schemes
Quality assurance (QA) schemes, such as those developed by Bord Bia and Bord Iascaigh Mhara, set out best practice requirements, identify current standards, promote continuous improvement, promote food safety controls, set high standards of animal welfare and provide a marketing tool to food businesses. QA schemes are subject to independent inspection and some are accredited under EN45011. Most managers of QA schemes intend to progress accreditation for all QA schemes. Standards for QA schemes are developed by technical advisory committees made up of producers, processors, farm organisations and state agencies, such as the FSAI. The FSAI participates in the development of standards for QA schemes and in an advisory role on the overall management of QA schemes.
European Food Safety Authority National Focal Point
The FSAI is the named EFSA National Focal Point for Ireland. The national focal points are considered EFSA’s ‘ambassadors’ in the Member States and serve as relay contacts between risk managers, national authorities, research institutes, stakeholders and consumers. The Focal Points ensure the adequate and timely two-way exchange of all relevant information. Further information on Ireland’s role as a National Focal Point can be found here.