Imports of foodstuffs of non-animal origin into the European Union (EU) must comply with general Regulation (EU)

2017/625 (CELEX 32017R0625) (the Official Controls Regulation - OCR) and specific provisions designed to prevent
risk to public health and protect consumers' interests.

Hence, general rules apply to these products:

1. General foodstuffs hygiene rules according to Regulation (EC) 852/2004 (CELEX 32004R0852);
2. General conditions of preparation of foodstuffs;
3. Official control of foodstuffs;

When a hygiene problem likely to pose a serious risk to human health arises or spreads in the territory of a third
country, the European authorities may suspend imports from all or part of the third country concerned or take interim
protective measures regarding the foodstuffs concerned, depending on the seriousness of the situation.

EU legislation establishing protective measures

1. General foodstuffs hygiene rules

The relevant hygiene rules of food which need to be respected by food business operators in third countries are
contained in Regulation (EC) 852/2004 (CELEX 32004R0852):

General obligation on the operator to monitor the food safety of products and processes under his responsibility;
General hygiene provisions for primary production and detailed requirements for all stages of production,
processing and distribution of food;
Microbiological criteria for certain products which are established in Regulation (EC) 2073/2005 (CELEX
32005R2073);
Procedures based on Hazard Analysis and Critical Control Point (HACCP) principles;
Approval and registration of establishments;

The following guidance documents may be found in the European Commission's Directorate-General for Health and
Food Safety website:

Guidance documents on hygiene of foodstuffs and food of animal origin and official controls

2. General conditions of preparation of foodstuffs

EU legislation lays down the rules relating to treatment of foodstuffs, food ingredients and their conditions of use in
order to protect the health of consumers and guarantee the free circulation of foodstuffs in the European Union market.

Moreover, specific provisions for groups of foods are laid down in specific Directives. These include compositional
requirements, hygiene requirements, list of additives, purity criteria, specific labelling requirements, etc

a) Authorised food additives and flavourings

The scope of the Directives covers food additives and flavourings used as ingredients during the manufacture or
preparation of food and which are part of the finished product.

The only substances which may be used as food additives are those included in the approved common lists and then
only under the conditions of use mentioned in those lists (e.g. colourants, sweeteners, preservatives, emulsifiers,
stabilisers, raising agents, etc...).

b) Preparation and treatments of certain foodstuffs

There are also rules in relation with the manufacture, marketing and importation of foods and food ingredients that are
subject to specific treatments such as Directive 89/108/EEC (CELEX 31989L0108) on quick-freezing or Directive
92/2/EEC (CELEX 31992L0002) on ionising radiation.

c) Specific provisions for certain groups of products and for foodstuffs

for particular nutritional purposes
Specific provisions are applied to certain groups of products (such as cocoa, sugar, etc.) and to foodstuffs intended for
particular nutritional uses (baby foods, dietary foods, gluten-free foods...). These may include specific requirements on
composition, hygiene, labelling (e.g. declaration of the energy value, carbohydrate, protein and fat content), list of
additives, purity criteria, etc.

Foods for specific groups

3. Control of foodstuffs
The new Regulation (EU) 2017/625 (CELEX 32017R0625) (Official Controls Regulation - OCR) provides that national
competent authorities shall carry out official controls on all operators at all stages of production, processing,
distribution and use of animals, goods, substances, materials or objects that are governed by agri-food chain rules.

Official controls carried out before the placing on the market or the movement of certain animals and goods in view of
the issuance of the official certificates or attestations (e.g. for plant health), shall be carried out in accordance with the
provisions laid down in the Regulation and delegated and implementing acts adopted by the Commission. In this regard,
Regulation (EU) 2019/2130 (CELEX 32019R2130) lays down detailed rules concerning the performance of documentary
checks, identity checks and physical checks at border control posts.

According to the OCR, these products can only be imported into the European Union (EU) if they come from a third
country included in a positive list of eligible countries for the relevant product (if required), are accompanied by the
proper official certificates, and have succeeded the mandatory control at the pertinent Member State's Border Control
Posts (BCPs).

Pursuant to the Offical Controls Regulation, certain categories of goods from certain third countries are always to be
presented at border control posts for official controls to be performed prior to their entry into the Union. In addition,
certain goods from certain third countries should be subject to a temporary increase of official controls at border
control posts when there is a known or emerging risk or an evidence of widespread serious non-compliance with the
Union agri-food chain legislation. Such goods should be subject to official controls at their entry into the Union.

Regulation (EU) 2019/1793 (CELEX 32019R1793) lays down provisions concerning the temporary increase of official
controls on certain food and feed of non-animal origin and the emergency measures currently applicable. This
Regulation establishes the list of food and feed of non-animal origin from certain third countries to be subject to a
temporary increase of official controls at the entry into the Union and the list of food and feed of non-animal origin
subject to emergency measures.

Each consignment of food and feed listed in Annex II shall be accompanied by an official certificate issued by the
competent authority of the third country of origin or of consignment in accordance with the model included in the
Regulation.

The list of animals and products subject to official controls at border control posts is set out in Regulation (EU)
2021/632 (CELEX 32021R0632).

As a result of the inspection at the border control post, national competent authorities shall issue a Common Health
Entry Document (CHED). Customs authorities shall only allow the release for free circulation of a consignment upon
presentation of a duly finalised CHED which confirms that the consignment is incompliance with the applicable rules
referred to in the Regulation.

The CHED shall be used by:

the operators in order to give prior notification to the competent authorities of the border control post of arrival of
the consignments
the competent authorities of the border control post, in order to:
record the outcome of the official controls performed and any subsequent decisions.
communicate this information referred to through the IMSOC.

TRACES (Trade Control and Export System) is the EU management tool for health certification of feed and food,
products of animal and non-animal origin, plants, seeds and propagating materials in intra-EU trade and imports to the
EU. It aims at digitising the entire sanitary certification process and linked procedures and allows for verification of the
certificate of inspection issued in the country of origin.

TRACES facilitates the exchange of information between the competent authorities in EU and EFTA countries and in
non-EU countries, in order to guarantee that the EU policy areas of DG Health and Consumers as regards 'Animal
Health', 'Animal Welfare' and 'Veterinary Public Health' are met. This network also promotes a better cooperation
between traders themselves and their competent authorities.

New computerised information management system for official controls (IMSOC) established by the OCR Regulation,
will be set up by EU Commision in collaboration with the Member States for the integrated operation of the
mechanisms and tools through which data, information and documents concerning official controls and other official
activities will be managed, handled, and automatically exchanged. It will allow all EU systems for official controls (e.g.
TRACES, EUROPHYT; IRASFF, AAC) to exchange information and share features. It will also connect them and extend
functionalities so that some systems will be absorbed.

EU legislation on health control of foodstuffs of non-animal origin.

Other information sources

Guidance documents on hygiene of foodstuffs and food of animal origin and official controls:
https://ec.europa.eu/food/food/biological-safety/food-hygiene/guidance-platform_en
Foods for specific groups: https://ec.europa.eu/food/safety/labelling-and-nutrition/specific-groups_en
Member State's Border Control Posts (BCPs):
https://ec.europa.eu/food/safety/official_controls/legislation/imports/non-animal_en
TRACES (Trade Control and Export System): https://webgate.ec.europa.eu/tracesnt/login
TRACES: https://ec.europa.eu/food/animals/traces_en
Guidance document on rules on food hygiene and official controls: https://ec.europa.eu/food/system/files/2016-
10/biosafety_fh_legis_guidance_interpretation_imports.pdf
Legislation on Plant Protection Products (PPPs): https://ec.europa.eu/food/plants/pesticides/legislation-plant-
protection-products-ppps_en
Microbiological criteria: https://ec.europa.eu/food/safety/biosafety/food_hygiene/microbiological_criteria_en
Rapid Alert System for Food and Feed (RASFF) Portal: https://webgate.ec.europa.eu/rasff-window/screen/search?
event=SearchForm&cleanSearch=1
Food Improvements - Food additives: https://ec.europa.eu/food/safety/food-improvement-agents/additives_en
Food Improvement Agents - Enzymes: https://ec.europa.eu/food/food/food-improvement-agents/enzymes_en
Food Improvements - Flavourings: https://ec.europa.eu/food/safety/food-improvement-agents/flavourings_en
Safe food additives: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=LEGISSUM:sa0003
Use of enzymes in foods (excluding those in additives): https://eur-lex.europa.eu/legal-content/EN/TXT/?
uri=legissum:sa0004
Food flavourings: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=LEGISSUM:sa0006