In response to the Coronavirus pandemic, the EU Commission has published an implementing regulation [en español: https://eur-lex.europa.eu/legal-content/ES/TXT/HTML/?uri=CELEX:32020R0466&from=EN ] providing greater flexibility to Member States when carrying out official controls on the agri-food chain. This measure is aimed at facilitating the continued movement of animals, plants, food and feed into and within the EU, in spite of the current circumstances, while also helping to prevent the spread of Covid-19 amongst or through those involved in administering official controls.
- For inspections, veterinary and phytosanitary controls on animals, plants, food and feed may exceptionally be carried out using specifically designated persons (e.g. where staff of competent authorities cannot reach the place where the control should be carried out, due to movement restrictions aimed at preventing the spread of the Coronavirus) (Article 3).
- For border checks, electronically submitted documents may exceptionally be accepted for completing checks if the person responsible commits to provide the original as soon as possible (Article 4).
- For testing and analysis, designated laboratories can exceptionally be used where normally used official laboratories are not available (Article 5).
- Physical meetings with operators may be replaced by contacts using available means of communication (Article 5).
Notwithstanding this added flexibility, it has been emphasised that the measure does not modify the substantive rules set out in EU legislation regulating public and animal health, food and feed safety and animal welfare.
Official Controls
The general principles with regard to feed and food law applicable in the European Union are laid down in Regulation (EC) 178/2002. In addition to those basic rules, further legislation addresses more specific feed and food law areas such as feed and food hygiene, food information for consumers and labelling, pesticides, feed and food additives, materials in contact with food, quality and compositional requirements, novel foods, foods for specific groups, health claims, and genetically modified organisms (GMOs) to name but a few.
While one of the core tenets of European food regulation provided for in Regulation (EC) 178/2002 is that ultimate responsibility for compliance with relevant legislation rests with food business operators themselves, Member States are required to enforce EU feed and food legislation as well as monitor and verify that the relevant requirements are fulfilled by business operators at all stages of the agri-food chain.
"Official Controls" are therefore defined as any form of control that a competent authority or the European Community performs for the verification of compliance with feed and food law, animal health and animal welfare rules. In Ireland, the competent authority in this regard is the Food Safety Authority of Ireland.
Recent Developments
Most of the provisions of a new Official Controls Regulation (the "NOCR") took effect on 14 December 2019. In this jurisdiction, the NOCR is also supplemented by the European Union (Official Controls in Relation to Food Legislation) Regulations 2020 (S.I. 79/2020) published on 20 March 2020. These new Irish Regulations revoke the European Communities (Official Control of Foodstuffs) Regulations 2010 and the European Communities (Official Control of Foodstuffs) (Amendment) Regulations 2011.
The following are some of the key changes introduced by the NOCR:
- "Other Official Activities"
Article 2 of the NOCR introduces a definition for what are termed "other official activities", which cover activities performed by competent authorities or delegated bodies other than "official controls". These "other official activities" include certain enforcement measures and/or remedial actions following non-compliance as well as the management of lists of registered/approved food and feed business operators or the issuance of official certificates. The NOCR sets out rules necessary to ensure that such activities are properly and effectively performed.
- Food Fraud
The general risk-based approach provided for in existing legislation, and detailed in Article 9 of the NOCR, is maintained. However, further provisions now clarify that competent authorities are required to carry out regular risk-based official controls directed at identifying and combatting fraudulent and deceptive practices by food business operators. Article 139(2) also provides that Member States shall ensure that financial penalties for violations of the provisions of the NOCR, perpetrated through fraudulent or deceptive practices, reflect either the economic advantage for the operator or, as appropriate, a percentage of the operator's turnover.
- Online Trading and Mystery Shoppers
Owing to the specific challenges arising from monitoring enforcement and ensuring compliance in the digital sphere, Article 15 of the NOCR includes provisions requiring food business operators to keep competent authorities updated regarding their online activities. Articles 35 and 36 of the NOCR relating to ‘second expert opinion’ and ‘sampling of animals and goods offered for sale by means of distance communication’ also provide that competent authorities may also now engage in mystery-shopping where they can purchase products online, disclosing only afterwards their official identity and the objective to perform an official control. Samples ordered online from operators by the competent authorities without identifying themselves may be used for the purposes of an official control, however, the operator is informed of this fact, and of their right to a second expert opinion, after authorities have taken possession of samples. Article 138(2) also makes provision for the closing of internet sites in the event of proven non-compliance.
- Witnesses and Whistleblowers
Article 140 relates to the reporting of infringements and provides that competent authorities have effective mechanisms to enable reporting of actual or potential infringements. These mechanisms must include procedures for the receipt of reports of infringements and their follow-up. These mechanisms must also include appropriate protection for persons reporting an infringement against retaliation, discrimination or other types of unfair treatment as well as the protection of the personal data of the person reporting an infringement.
- Transparency Requirements
Transparency requirements for competent authorities are clarified in Article 11 of the NOCR by identifying the minimum level of information which must be made public and at what frequency. Competent authorities are required to provide food business operators with copies of reports where non-compliance has been detected as well as where compliance has been achieved. New provisions regulate the delegation of specific tasks relating to ‘other official activities’ and the conditions to be met for delegating certain official tasks. The NOCR also expands upon the European Union’s existing legal basis for the financing of official controls. This includes, in particular at Article 85, a greater emphasis on transparency.
- Import Controls
Articles 43 – 77, 90, 126 -128 and Article 134 of the NOCR contain revised rules regarding import controls and import conditions on animals and goods arriving in the European Union from third countries. These changes are intended to create a common framework for all goods covered by the NOCR across the agri-food chain. Central to this project is the re-designation of all existing specialised border facilities, such as Designated Points of Entry (DPEs) and Border Inspection Posts (BIPs) as Border Control Posts (BCPs). Furthermore, existing entry documents, such as the Common Entry Document (CED) for high-risk food not of animal origin and the Common Veterinary Entry Document (CVED) for products of animal origin, will be amalgamated as Common Health Entry Documents (CHEDs). These systemic changes will be underpinned by a new Information Management System for Official Controls (IMSOC). This platform will link existing systems, such as RASFF and TRACES, rather than replacing any elements of the Commission’s existing IT monitoring infrastructure.
- National Reference Laboratories & Official Control Laboratories
National Reference Laboratories (NRLs) & official control laboratories (OCLs) will see minor changes to the responsibilities placed upon them (Articles 34, 38, 40, 42, 92, 94, 100 & 101), although the changes for NRLs have applied since April 2018. Changes to the responsibilities of OCLs (applicable from December 2019) will mean that competent authorities are required to have closer contact with the laboratories and greater oversight of delegated laboratories.
- Cross-Border Incidents
Articles 102 – 108 of the NOCR subject competent authorities to tighter rules and more formalised processes for interacting with authorities in other Member States when responding to cross-border incidents. For example, competent authorities who receive a request for assistance from authorities in another Member State can be required to indicate within ten working days from the date of receipt of the request, the estimated time necessary to provide an informed response to the request - Article 104(1)(b).
- Multi-Annual National Control Plans
It is an existing requirement that all Member States have such a national control plan, the purpose of which is to ensure that effective systems are in place for monitoring and enforcing feed and food law, animal health and animal welfare rules, and plant health law in that Member State. Progress on implementation is continually monitored and annual reports are prepared and submitted to the European Commission. In order to ensure the uniform presentation of annual reports, the NOCR provides for implementing acts to adopt and update standard model forms to be used for annual submission of the information. The EU have now finalised and published these model forms under Commission Implementing Regulation (EU) 2019/723.
- Tertiary Legislation
Article 144 of the NOCR also empowers the creation of tertiary legislation (implementing acts and delegated acts) which allow for the creation of further detailed rules in specific areas. The majority of this tertiary legislation so far, which has been under development since 2017, has addressed import controls and conditions. New rules have also been published regarding hygiene inspections for products of animal origin. This tertiary legislation also came into force from 14 December 2019, although this feature of the NOCR does leave open the possibility of further changes going forward.
Conclusion
The food sector remains one of the most valuable and highly regulated sectors of the EU economy. Although various features of the NOCR seek to formalise and harmonise existing arrangements by integrating them into a single legislative framework for official controls, the key development brought about by this new legislation is its expanded scope across the entire agri-food chain and into sectors previously not harmonized with regard to enforcement.
This gives rise to increased opportunities and responsibilities on the part of competent authorities to extend their activities in areas such as food fraud and online enforcement. Unlike other sectors such as pharmaceuticals however, the EU food sector is far more fragmented, with a high level of turnover being accounted for by small and medium sized business. The vast majority of these operators proactively ensure that they are in compliance with food and feed law rules applicable to their business, however they are often reliant on competent authorities and their inspectors for direction and reassurance.
Notwithstanding the added flexibility now being provided to competent authorities as a result of the Covid-19 pandemic, providing continued assistance and information to networks of operators seeking to ensure compliance across the entire agri-food chain in a period of unprecedented challenge should remain as a key objective going forward.
Written by James Gallagher (Ireland)
