Toiduseadus (ToiduS)

§ 2. Food

For the purposes of this Act, ‘food’ means a substance or product specified in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council.

§ 3. Primary production and primary product

(1) For the purposes of this Act, ‘primary production’ means an activity specified in Article 3(17) of Regulation (EC) No 178/2002 of the European Parliament and of the Council.

(2) For the purposes of this Act, ‘primary product’ means products specified in Article 2(1) of Regulation (EC) No 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs (OJ L 139, 30.04.2004, pp 1-54).

§ 6. Operator and food handling

(1) For the purposes of this Act, ‘operator’ means a person specified in Article 3(13) of Regulation (EC) No 178/2002 of the European Parliament and of the Council

(1¹) The legal representative of a business operator who is a legal person shall organise the performance of duties of a legal person arising from this Act.

(2) For the purposes of this Act, ‘handling of food’ (hereinafter handling) means an activity within the stages or production, processing and distribution of food provided in Article 3(16) of Regulation (EC) No 178/2002 of the European Parliament and of the Council.

(3) For the purposes of this Act, ‘retail’ means an activity specified in Article 3(7) of Regulation (EC) No 178/2002 of the European Parliament and of the Council.

§ 7. Notification obligation

(1) A notice of economic activities must be submitted to the Agriculture and Food Board for:

1) handling food in an establishment specified in Article 6(2) of Regulation (EC) No 852/2004 of the European Parliament and of the Council;

2) manufacture, processing and distribution of food contact materials and articles in a business specified in Article 2(2)(c) of Regulation (EC) No 1935/2004 of the European Parliament and of the Council.

(2) In addition to the data specified in the General Part of the Economic Activities Code Act, the notice of economic activities must set out the following:

1) in the case of the field of activity specified in clause 1 of subsection 1 of this section, information about the field of handling and the food group;

2) in the case of the field of activity specified in clause 2 of subsection 1 of this section, information about the group of the food contact materials and articles.

(3) A detailed list of the fields of handling and food groups specified in clause 1 of subsection 2 of this section, whereby the operator must submit a notice of economic activities, is established by a regulation of the minister in charge of the policy sector.

(4) A notice of economic activities does not need to be submitted for commencement of economic activities in the field of activity specified in clause 1 of subsection 2 of this section where:

1) an activity licence must be held in accordance with § 8 of this Act or Article 6(3)(b) or (c) of Regulation (EC) No 852/2004 of the European Parliament and of the Council in order to handle food in the establishment;

2) in accordance with Article 1(2)(c) of Regulation (EC) No 852/2004 of the European Parliament and of the Council or Article 1(3)(c) of Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin (OJ L 139, 30.04.2004, pp 55–205), the requirements established by such Regulations do not apply to the establishment;

3) the animal establishment has been registered in the register of farm animals;

4) the operator holds an activity licence for handling medicinal products.

(5) A notice of economic activities does not need to be submitted in order to commence economic activities in the field of activity specified in clause 2 of subsection 1 of this section where the business specified in Article 2(2)(c) of Regulation (EC) No 1935/2004 of the European Parliament and of the Council must be reported in accordance with clause 1 of subsection 1 of § 7 of this Act or where the business must hold a food handling activity licence in accordance with § 8 of this Act.

(6) The information specified in this section is entered in the national register of food and feed business operators under § 23 of the Feed Act.

(7) The operator does not have to pay a state fee for entering the information contained in a notice of economic activities specified in subsection 1 of this section in the national register of food and feed business operators.

§ 8. Licence obligation

(1) The operator must hold an activity licence for handling food in the following establishments, businesses or institutions:

1) an establishment specified in Article 6(3)(b) and (c) of Regulation (EC) No 852/2004 of the European Parliament and of the Council;

1¹) an establishment that is engaged in retail trade (hereinafter retail establishment) and handles food of animal origin that is supplied to a retail establishment of the same operator or solely to another retail operator, except where the supply in accordance with the requirements established on the basis of subsection 3 of § 26 of this Act is marginal, local and limited;

1²) a preschool, basic school, upper secondary school, health care and social welfare institution, custodial institution and the Defence Forces where food is provided;

9) an establishment specified in Article 23(1) of Commission Delegated Regulation (EU) 2019/2124 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards rules for official controls of consignments of animals and goods in transit, transhipment and onward transportation through the Union, and amending Commission Regulations (EC) No 798/2008, (EC) No 1251/2008, (EC) No 119/2009, (EU) No 206/2010, (EU) No 605/2010, (EU) No 142/2011, (EU) No 28/2012, Commission Implementing Regulation (EU) 2016/759 and Commission Decision 2007/777/EC (OJ L 321, 12.12.2019, pp 73–98), which is engaged in warehousing food of animal origin.

(2) An activity licence gives the operator the right to commence and pursue economic activities only in or with regard to the establishment or business specified in the activity licence.

(3) A detailed list of the fields of handling and the food groups whereby the operator must hold an activity licence is established by a regulation of the minister in charge of the policy sector.

§ 9. Applying for activity licence

(1) An application for an activity licence is reviewed by the Agriculture and Food Board.

(2) In addition to the information required in the General Part of the Economic Activities Code Act, an application for an activity licence must contain the following data and documents:

1) the list of the food groups for the handling of which the activity licence is being applied for;

3) the layout of the rooms along with the layout of the machinery, equipment and indoor water supply and sewerage lines. All the water points must be numbered in the layout of the water supply network. The layout of the rooms must indicate paths of movement of food, packaging materials, waste and staff;

5) the numeric values of the relevant regulated parameter of the rooms with a regulated temperature or the rooms with relative humidity or the rooms with regulated temperature and relative humidity;

6) the technological scheme of the handling process along with parameters that are of relevance from the point of view of food safety and a short description of the technology;

7) the designed and planned or actual handling capacity, including the capacity of the storage facilities;

8) the test protocols of the water used in the business, which focus on the indicators investigated in the course of regular examination of the drinking water prescribed by subsection 2 of § 13 of the Water Act. the test protocols must be issued for analysing the drinking water by an accredited laboratory;

8) the test protocols of the water used in the business, which focus on the indicators investigated in the course of regular examination of the drinking water prescribed by subsection 2 of § 13 of the Water Act. the test protocols must be issued for analysing the drinking water by an accredited laboratory;

9) the cleaning and disinfection plan that contains information on the measures taken and substances used for cleaning and disinfecting the equipment and rooms;

10) the pest control plan that contains information on the measures taken for controlling pest;

11) the plan for the collection, removal and inactivation of food waste, by-products not used for food and other waste, which contains information on the measures taken for colleting, removing and inactivating these;

12) the food hygiene training plan of the employees coming into contact with food;

13) information on the means of transport used for the carriage of food and a description of cleaning the means of transport and circulating transportation packaging.

(3) The information specified in this section is entered in the national register of food and feed business operators under § 23 of the Feed Act.

(4) The operator does not have to pay a state fee for a review of an application for the activity licence specified in subsection 1 of § 8 of this Act.

§ 10. Object of control of activity licence

An activity licence is granted to an operator where the establishment or business used by it for handing food complies with the requirements established in Regulations (EC) No 852/2004 and 853/2004 of the European Parliament and of the Council and in other relevant food-related legislation.

§ 10¹. Secondary conditions of activity licence

The following secondary conditions apply to an activity licence:

1) the field of handling;

2) the food group.

§ 12. General requirements

(1) Food to be placed on the market must be safe for human health and comply with other requirements provided in this Act and other legislation (hereinafter compliant).

(2) Food must not contain parasites, pests or foreign substances that harm the properties of the food or endanger human health.

(3) It is prohibited to handle food which is spoilt or contaminated or which does not comply with microbiological requirements, or food spoilt as a result of the use of an unsuitable manufacturing process or due to odour, flavour, colour or other circumstances which are not characteristic of the food.

(4) In addition to the provisions of this Chapter, food must comply with the composition and quality requirements characteristic of the food. The composition and quality requirements per food group is established by a regulation of the minister in charge of the policy sector.

§ 13. Novel food and genetically modified food

(1) A novel food within the meaning of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, pp 1–22) may be placed on the market only in compliance with the requirements of the Regulation.

(2) Genetically modified organisms and genetically modified food used for human consumption within the meaning of Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed(OJ L 268, 18.10.2003, pp 1–23) may be placed on the market only in compliance with the requirements of the said Regulation.

(3) The Agriculture and Food Board is the competent agency within the meaning of Article 5(2) of Regulation (EC) No 1829/2003 of the European Parliament and of the Council.

§ 14. Food for particular nutritional uses

(1) For the purposes of this Act, ‘food for particular nutritional uses’ means an infant formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes and total diet replacement for weight control set out in Articles 2(2)(c)–(h) of Regulation (EU) No 609/2013 of the European Parliament and of the Council on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.06.2013, pp 35–56).

(2) The person who is responsible for placing on the Estonian market for the first time such a food for particular nutritional uses, which is subject to the notification requirement under Article 11(1)(d) of Regulation (EU) No 609/2013 of the European Parliament and of the Council, must inform the Agriculture and Food Board not later than on the day of placing the food on the market, submitting the labelling used in the case of the food for particular nutritional uses to be placed on the market along with the notification that contains at least the following information:

1) the name, address of the residence or seat, and telecommunications numbers of the person responsible for placing the food for particular nutritional uses on the market;

2) the name of the food;

3) the date of placing the food for particular nutritional uses on the Estonian market.

(3) The Agriculture and Food Board may request that the person responsible for placing the food for particular nutritional purposes on the market submit additional scientific data that confirm the existence of the special characteristics of the food. Where this information is public, a reference to a relevant publication or other permanent place of access is sufficient.

§ 14¹. Food supplement

(1) ‘Food supplement’ means food the purpose of which is to attribute to the food for normal consumption and which is a concentrated source of nutrients or other substances with nutrient or physiological effect. These substances may be presented individually or in combinations and are placed on the market in sales packaging and in specified doses, such as capsules, pastilles, tablets and other similar products, as well as sachets of powder, ampoules with liquid, drop-bottles, etc., designed for using liquid or powder in small measured quantities.

(2) When a food supplement is placed on the market for the first time in Estonia, the person responsible for placing it on the market informs the Agriculture and Food Board thereof not later than on the day when it is placed on the market by delivering the specimen of labelling to be used with the food supplement, together with the notice containing at least the following information:

1) the name, address of the residence or seat, and telecommunications numbers of the person responsible for placing the food for particular nutritional uses on the market;

2) name of the food supplement;

3) the date of placing the food supplement on the market in Estonia.

§ 15. Frozen food

(1) ‘Frozen food’ means food that has been subjected to a freezing process and then stored at the temperature prescribed for the food or raw material for food. In order to ensure the compliance of such food with the requirements, the period of freezing must be as short as possible.

(2) The requirements provided in Regulations (EC) No 852/2004 and 853/2004 of the European Parliament and of the Council and in other legislation and the special requirements for handling frozen food established by a regulation of the minister in charge of the policy sector must be observed during handling frozen food.

§ 16. Food additive

(1) For the purposes of this Act, ‘food additive’ means a substance specified in Article 3(2)(a) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives (OJ L 354, 31.12.2008, pp 16–33).

(2) It is permitted to use a food additive in accordance with the requirements provided in Regulation (EC) No 1333/2008 of the European Parliament and of the Council.

(4) Food additive that comply with the requirements provided in Commission Regulation (EU) No 231/2012, laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.03.2012, pp 1–295), are permitted in food.

§ 17. Artificial flavourings

(1) For the purposes of this Act, ‘artificial flavourings’ means products specified in Article 3(2)(a) of Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC.

(1¹) Artificial flavourings may be used in food in accordance with the requirements provided in Regulation (EC) No 1334/2008 of the European Parliament and of the Council.

(2) The competent authority within the meaning of Article 7(2) of Regulation (EC) No 2065/2003 of the European Parliament and of the Council on smoke flavourings used or intended for use in or on foods (OJ L 309, 26.11.2003, pp 1–8) is the Agriculture and Food Board.

§ 18. Processing aid

(1) For the purposes of this Act, ‘processing aid’ means substances specified in Article 3(2)(a) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council.

(2) The requirements for processing aids, the conditions and methods of use thereof and the permitted levels of residue content in food are established by a regulation of the minister in charge of the policy sector.

§ 19. Contaminant

(1) ‘Contaminant’ means a substance which is present in food as a result of substances used in the primary production, or which is present during handling or as a result of environmental contamination, and which may endanger human health or harm the properties of the food.

(3) The minister in charge of the policy sector may establish the list and levels of permitted contaminants by food group.

§ 20. Food counterfeiting

(1) It is prohibited to counterfeit food and handle counterfeit food.

(2) The following is deemed to be counterfeiting:

1) alteration of the composition of food without alteration of the labelling;

2) alteration of labelling without alteration of the actual composition;

3) addition of other substances in any manner to food or processing food with such substances in order to conceal the lower value of the food or non-compliance of the food with the requirements;

3¹) non-compliant use of a health mark or identification mark on the labelling;

4) handling during which the business name or trade mark of another undertaking is used without the permission of the undertaking.

§ 21. Ensuring compliance of food upon handling

(1) Handling must be carried out in compliance with the requirements provided in this Act and other legislation and during handling it must be ensured that the food which is obtained complies with the requirements.

(2) During handling it is prohibited to use substances or materials whose composition or effect on humans is not known, which do not conform to the requirements provided in legislation, or the use of which is prohibited by legislation.

(3) It is prohibited to store substances and materials which may cause the contamination of food or harm the properties thereof at handling sites.

(4) Where, as a result of examinations, the harmfulness of a treatment or substance to human health becomes evident, it is prohibited to use it upon handling food. The list of treatments and substances that are prohibited upon handling food is established by a regulation of the minister in charge of the policy sector. Special handling requirements for treatments and substances which may be used upon handling food in certain events and the requirements that set out the permitted events and the manner of use of such treatments and substances are established by a regulation of the minister in charge of the policy sector.

§ 21¹. Permit for the treatment of food with ionising radiation

(1) Food may be treated with ionising radiation with the permission of the Agriculture and Food Board.

(2) In order to obtain a permit for the treatment of food with ionising radiation, the operator submits to the Agriculture and Food Board a written application containing the following information and documents:

1) the name, registry code and contact details of the applicant;

2) the data on food treated with ionising radiation;

3) the description of the purpose of the treatment of food with ionising radiation;

4) the data on the radiation source used for the treatment of food with ionising radiation;

5) the confirmation that the operator has been granted a radiation practice licence under the Radiation Act.

(3) The Agriculture and Food Board shall decide on the granting or refusal of a permit for the treatment of food with ionising radiation within 20 working days of receipt of the application referred to in subsection 2 of this section.

(4) The Agriculture and Food Board shall take a decision refusing to grant a permit for the treatment of food with ionising radiation if:

1) the applicant does not have a radiation practice licence;

2) the application contains false information or the proposed ionising radiation treatment of food does not comply with the relevant requirements laid down in or established pursuant to section 21 of this Act.

(5) The Agriculture and Food Board shall submit to the European Commission the decision on the granting of a permit for the treatment of food with ionising radiation and the decision on its revocation.

§ 22. Duties of operator upon handling

(1) An operator is responsible for the compliance of handled food and handling with the requirements, and is required to seize every opportunity in order to ensure such compliance.

(2) An operator observes the storage requirements set out on the packaging or in the accompanying document of food, as determined by the producer, processor (including the maker) or packager of the food.

(3) An operator must not accept, use during handling or distribute food that does not comply with the requirements.

(4) It is prohibited to use food of animal origin where the animal has been treated with medicinal products or substances having a hormonal action and the withdrawal period after use thereof has not ended.

§ 23. Traceability of food

An operator must guarantee the traceability of food in accordance with Article 18 of Regulation (EC) No 178/2002 of the European Parliament and of the Council.

§ 24. Technical description of food

(1) Upon preparation of food, except preparation of food marketed only on the premises of mass caterers, an operator must observe the requirements of the technical description of food which is selected or prepared by the operator.

(2) For the purposes of this Act, ‘technical description of food’ means any document which describes the properties and preparation of the food and contains the following information concerning the food:

1) the name;

2) the properties of the finished product and of the ingredients thereof;

3) the manufacturing process used, above all, the aspects which are significant for food safety;

4) the methods of assessment of compliance with the requirements;

5) the description of the packaging and food information;

6) the transportation and storage conditions.

(3) A technical description prepared by an operator and amendments made thereto are prepared as a document which sets out, in addition to the information specified in subsection 2 of this section, the date of its preparation and the name and official title of the person who approved the document by their signature.

§ 25. Conditions in establishments and businesses

(1) The technical conditions and organisation of work of establishments and businesses must enable observance of the requirements provided in this Act and other legislation.

(2) Where circumstances become evident which bring about or may bring about changes to these conditions to an extent that means that food safety is not ensured, an operator must promptly notify the Agriculture and Food Board thereof.

(3) The building and room used for storing food of animal origin in an establishment specified in clause 9 of subsection 1 of § 8 of this Act must comply with the requirements set out in Article 23 of Commission Delegated Regulation (EU) 2019/2124.

§ 26. Food hygiene

(1) For the purposes of this Act, ‘food hygiene’ means the measures and conditions specified in Article 2(1) of Regulation (EC) No 852/2004 of the European Parliament and of the Council.

(2) Food hygiene requirements are established by Regulations (EC) No 852/2004 and 853/2004 of the European Parliament and of the Council.

(3) Food hygiene requirements in matters which, in accordance with the Regulations specified in subsection 2 of this section, the Member State have the right to decide, or other relevant requirements are established by a regulation of the minister in charge of the policy sector.

(3¹) The size of the animal unit specified in subsection 3³ of this section and the small product quantities, requirements for the structure, design solution and equipment hygiene of the establishment and hygiene rules for handling food in a retail establishment set out in Article 1 and Article 13(3) of Regulation (EC) No 852/2004 of the European Parliament and of the Council and Article 1 and Article 10(3) of Regulation (EC) No 853/2004 of the European Parliament and of the Council may be established as the requirements specified in subsection 3 of this section.

(3²) The requirements for the establishment’s structure, design solution and hygiene equipment provided in subsection 3¹ of this section may be applied by an operator who, for the purposes of Article 2(3) of the Annex to Commission Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.05.2003, pp 36–41), is a microenterprise, except for an operator engaged in slaughtering animals. For the purposes of considering an operator a microenterprise, only food handling-related turnover is taken into account as their taxable turnover.

(3³) The requirements provided in subsection 3¹ of this section for the establishment’s structure, design solution and hygiene equipment may be applied in an establishment engaged in slaughtering animals where animals are slaughtered or game is handled only during a part of the working day or where animals are slaughtered and game is handled throughout the working day but not on every working day of the week and where:

1) a number of animals corresponding to up to 1,000 animal units is slaughtered annually;

2) a number of animals corresponding to up to 200 animal units is slaughtered annually, provided that meat-cutting is carried out in the same room, or

3) up to 150,000 poultry, lagomorphs or small game are slaughtered annually.

(3⁴) Where an operator whose food handling-related turnover does not exceed 40,000 euros per calendar year prepares on premises used primarily as a private dwelling specified in Chapter III of Annex II of Regulation (EC) No 852/2004 of the European Parliament and of the Council food for placing on the market, the operator may apply in a retail establishment specified in subsection 3¹ of this subsection the hygiene requirements applicable to handling food of animal origin.

(4) The Agriculture and Food Board is the competent agency within the meaning of Regulation (EC) No 852/2004 and Regulation (EC) No 852/2004 of the European Parliament and of the Council.

(5) In following the food hygiene requirements, operators may take guidance from the guidelines for good hygiene practice (hereinafter guidelines) compiled by an operator, association of operators or any other interested party in cooperation with other relevant parties. The guidelines are prepared taking account of the standards of Codex Alimentarius that is the common standards programme of the Food and Agriculture Organisation of the United Nations Organisation and of the World Health Organisation (WHO).

(6) The conformity of the recommendations provided by the guidelines referred to in subsection 5 of this section to food hygiene requirements is assessed by the Agriculture and Food Board who has the right to propose amendments to the guidelines.

(7) The person specified in subsection 5 of this section submits the guidelines which have been declared to comply with the requirements set out in Article 7 of Regulation (EC) No 852/2004 of the European Parliament and of the Council to the Ministry of Regional Affairs and Agriculture who forwards it, in the events specified in the Regulation, to the European Commission.

§ 27. Employee of establishment or business

(1) An operator is required to explain the handling requirements arising from legislation to an employee and verify compliance therewith.

(2) An employee who handles food must have professional knowledge and know and observe the food hygiene requirements.

(3) An employee who does not directly handle food must know and adhere to the food hygiene requirements to the extent necessary to ensure food safety.

(4) An operator must organise the supervision of an employee with regard to food hygiene.

§ 28. Medical examination of employee

The Communicable Diseases Prevention and Control Act applies to the medical examination of an employee.

§ 29. Food hygiene training in establishment or business

(1) An operator must prepare a plan concerning food hygiene training for the employees of the establishment or business who come into contact with food, setting out the purposes, scope, timetable and procedure of the training.

(2) On the basis of a training plan, an operator must periodically organise food hygiene training that corresponds to the duties of the employees and assess the knowledge of the employees concerning food hygiene.

(3) The execution of the training plan is monitored by the law enforcement authority that has the right to make proposals for amendment of the training plan and give explanations concerning drawing up the plan.

(4) The requirements provided in subsections 1–3 of this section do not apply to producers to whom the requirements of Annex I to Regulation (EC) No 852/2004 of the European Parliament and of the Council apply, or to producers to whom the requirements of Regulations (EC) No 852/2004 and (EC) No 853/2004 of the European Parliament and of the Council do not apply, unless otherwise provided by other Acts or legislation established on the basis thereof.

§ 30. Cleaning, disinfection and pest control

(1) In order to clean and disinfect an establishment or business and its territory, premises, machinery and handling equipment and in order to conduct pest control, an operator must use only such equipment, substances and methods which do not cause the contamination of food, harm the properties thereof or endanger human health. Cleaning products, disinfectants and pest control products must be used in accordance with the instructions prepared by the producer of such products.

§ 31. Materials and articles intended to come into contact with food

(1) Materials and articles intended to come into contact with food must not cause the contamination of food, harm the properties thereof or endanger human health and must comply with the requirements for materials and articles permitted to come into contact with food.

(2) The requirements for materials and articles permitted to come into contact with food, the special requirements for the groups thereof and the methods for testing the safety of such materials and articles are established by a regulation of the minister in charge of the policy sector.

§ 32. Water used

(1) An establishment or business must have an adequate supply of water which complies with the requirements for drinking water established on the basis of the Water Act (hereinafter drinking water).

§ 34. Self-checking requirement

(1) An operator is required to verify the compliance of food and the handling thereof with the requirements (hereinafter self-checkin g) and to implement measures in order to ensure such verification. Measures to be implemented are described in a self-check plan. Self-checking together with a self-check plan drawn up in writing forms a self-checking system.

(2) An operator determines the stages of handling which are significant in terms of food safety, including critical control points, monitors them and registers the results of the monitoring in accordance with the requirements of Article 5 of Regulation (EC) No 852/2004 of the European Parliament and of the Council and Regulation (EC) No 853/2004 of the European Parliament and of the Council.

(5¹) In the event of analysis of samples collected in the framework of self-checking, a relevant quality system is applied.

§ 35. Declaration of conformity

(1) A declaration of conformity that certifies the compliance of food with the requirements is a written document issued by the producer of the food that confirms that the food complies with the requirements provided in legislation or other requirements. A declaration of conformity is issued at the request of an operator who further handles the food.

(2) A declaration of conformity confirms that the food complies with the requirements specified in the declaration, provided that the requirements set out by the issuer are observed during further handling.

(3) A declaration of conformity is issued for a specified period for continual preparation of the same food or with regard to a lot. An amount of food that is produced, prepared or packed under the same conditions and with the same name and properties is deemed to be a lot. Each lot must have specific identification.

(4) Where a declaration of conformity is issued for the continual preparation of food, the lots included therein must be related to the declaration of conformity. A declaration of conformity issued with regard to a lot must include a reference to the specific lot.

§ 36. Content of declaration of conformity

A declaration of conformity must contain the following information:

1) the name of the issuer, the address of the seat of the issuer and the mark of identification of the declaration of conformity;

2) the name of the food and other information necessary for determination of the food;

3) a reference to the requirements to which conformity is proved;

4) the date of issue and the name, signature and position of the person who issued the declaration of conformity.

§ 37. Certification

(1) Certification is a procedure which is organised by an independent third party (hereinafter certification body) on the basis of a written application from an operator in order to prove the compliance of the quality system of the operator or the compliance of a specific handled food with the requirements, in respect of which the application for proof of conformity is made.

(2) Certification is optional and an operator who applies for certification bears the expenses of certification.

(3) Where certification provides a positive result, the certification body issues a certificate of conformity that confirms the compliance of the food or the quality system with the requirements.

§ 38. Requirements for information

(1) ‘Food information’ means information specified in Article 2(2)(a) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, pp 18–63).

(2) Food information must be true, comply with requirements established by legislation and must not mislead the handler or the consumer. Food which is sold or transferred in some other manner to the consumers must be labelled in a manner that ensures the necessary information about the food.

(3) In the case of food sold or otherwise delivered to the consumer in Estonia, food information is provided in Estonian, unless the information provided in another language or in another manner is understandable to the consumer.

(4) The requirements for provision of food information per food group or treatment are established by a regulation of the minister in charge of the policy sector.

(5) For the purpose of implementation of Articles 44(1)(b) and 44(2) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council, the requirements for provision of food information on non-prepackaged food are established by a regulation of the minister in charge of the policy sector.

(6) The requirements for identification of a lot are established by a regulation of the minister in charge of the policy sector.

§ 40. Restriction on alteration of labelling

(1) The alteration of labelling without the alteration of the actual properties of food is deemed to be adulteration of the food, except for the specification of labelling or the correction of misleading labelling.

(2) It is prohibited to repackage food where the ‘use by’ date or the date of minimum durability is indicated on the sales packaging of the food. The date on the sales packaging must not be altered and the food must not be marketed after the ‘use by’ date has expired.

§ 41. Terms of bringing food to Estonia and export of food

(1) For the purposes of this Act, bringing food to Estonia means an activity specified in Article 3(40) of Regulation (EU) No 2017/625 of the European Parliament and of the Council.

(1¹) Bringing food to Estonia and the export of food is permitted through a border control post which is open to international traffic on the basis of the State Borders Act.

(3²) Where, in accordance with relevant legislation of the European Union, the controls of the compliance of bringing food to Estonia with the rules must be performed at a border control post or at the place of the official controls of imported food, such food may be brought to Estonia only through the border control post determined by the Agriculture and Food Board or a place of official controls of imported food.

(4) The food specified in the list established on the basis of Article 47(2)(a) of Regulation (EU) No 2017/625 of the European Parliament and of the Council is not subject to the requirements provided in this Chapter.

§ 42¹. Border control post

(1) On the basis of an application of the owner or possessor of a border control post opened for international traffic under the State Borders Act, the Agriculture and Food Board designates the border control post through which it is permitted to bring food to Estonia (hereinafter border control post), provided that a Member State has the right to determine the border control post in accordance with the relevant legislation of the European Union.

(2) The list of border control posts is published on the website of the Agriculture and Food Board in accordance with the requirements of Article 60 of Regulation (EU) No 2017/625 of the European Parliament and of the Council.

(3) In accordance with Article 59(2) of Regulation (EU) No 2017/625 of the European Parliament and of the Council, the Agriculture and Food Board notifies the European Commission of the intent to designate a border control post.

(4) After receiving a notice specified in paragraphs 3–5 of Article 59 of Regulation (EU) No 2017/625 of the European Parliament and of the Council, the Agriculture and Food Board makes a respective decision without delay.

(5) In an event provided in Article 62(1) and Articles 63(1) and (4) of Regulation (EU) No 2017/625 of the European Parliament and of the Council, the Agriculture and Food Board makes a respective decision and change in the list of border control posts and notifies the European Commission and other Member States thereof in accordance with Articles 62 and 63 of the Regulation.

(6) The requirements for the contents of an application for the designation of a border control post and the procedure for processing applications set out in subsection 1 of this section are established by a regulation of the minister in charge of the policy sector.

§ 42². Place of official controls of imported food

(1) On the basis of a person’s application, the Agriculture and Food Board designates a place of official controls of imported food, provided that a Member State has the right to designate it in accordance with the relevant legislation of the European Union. The place of official controls is located in a place accepted by the Tax and Customs Board.

(2) The list of places of official controls of food imported in accordance with the requirements referred to in Article 53(2) of Regulation (EU) No 2017/625 of the European Parliament and of the Council is published on the website of the Agriculture and Food Board.

(3) Where a place of official controls meets the requirements referred to in Article 53(1)(a) of Regulation (EU) No 2017/625 of the European Parliament and of the Council, the Agriculture and Food Board makes a decision to designate the place of official controls of imported food.

(4) Where a place of official controls does not meet the requirements referred to in Article 53(1)(a) of Regulation (EU) No 2017/625 of the European Parliament and of the Council, the Agriculture and Food Board makes a decision to refuse to designate the place of official controls of imported food.

(5) The Agriculture and Food Board makes a decision specified in subsection 3 or 4 of this section within 30 working days after the receipt of an application for the designation of the place of the official controls of imported food.

(6) In an event provided in Article 62(1), Articles 63(1) and (4) and Article 53(2) of Regulation (EU) No 2017/625 of the European Parliament and of the Council, the Agriculture and Food Board makes a respective decision and change in the list of places of official controls and notifies the European Commission and other Member States thereof in accordance with Articles 62 and 63 of the Regulation.

(7) The requirements for the contents of an application for the designation of a place of official controls and the procedure for processing applications set out in subsection 1 of this section are established by a regulation of the minister in charge of the policy sector.

§ 43. Official controls and other official operations in case of export of food

(4) In the event of export of food, the Agriculture and Food Board issues an official certificate (hereinafter certificate) where the submission thereof is required in a state located outside the customs territory of the European Union.

(5) The Agriculture and Food Board publishes the certificate type and form and relevant information on the food set out in the certificate on its website based on the requirements of the state located outside the customs territory of the European Union.

(6) To obtain a certificate, a written application is submitted to the Agriculture and Food Board at least 24 hours before exporting food.

(7) An application specified in subsection 6 of this section must contain relevant information which allows for exercising official control and completing the form of the certificate. The Agriculture and Food Board may demand that the applicant submit the required data also in the language of the country of destination.

(8) A certificate is not issued where the Agriculture and Food Board has established at least one of the following circumstances:

1) the food does not meet the relevant requirements;

2) the application has not been submitted in accordance with the requirements provided in subsections 6 and 7 of this section;

3) the application contains false information.

§ 44. Notification of bringing food to Estonia

(1) The Agriculture and Food Board is informed of the bringing to Estonia of food over which official controls must be performed at a border control post or at a place of official controls of imported food in accordance with the relevant legislation of the European Union at least one working day before the presentation of the food for official controls.

§ 46³. Provider of vital service

(1) In the area established in subsection 3 of § 46² of this Act, the supply of food to the population is significantly affected by an undertaking whose annual revenue in that area is the highest in comparison with the revenue of other undertakings operating in the same area.

(2) In the production of cereal, bakery or pasta products established in clause 1 of subsection 3 of § 46² of this Act, the annual revenue of an undertaking in that area shall be taken as the basis.

(3) In the handling of meat established in clause 2 of subsection 3 of § 46² of this Act, the annual revenue of an undertaking in that area shall be taken as the basis.

(4) In the handling of milk established in clause 3 of subsection 3 of § 46² of this Act, the annual revenue of an undertaking in that area shall be taken as the basis.

§ 46⁴. Designation of provider of vital service

(1) The compliance of an undertaking with the requirements set out in § 46³ of this Act shall be established on the basis of its annual report and the data of the national register of food and feed business operators.

(2) The provider of vital service shall be determined on the basis of the average of the data specified in subsection 1 of this section for the two years immediately preceding the year of designation.

(3) The detailed conditions and procedure for designating a provider of vital services in the area of food supply shall be established by a regulation of the minister in charge of the policy sector.

§ 46⁵. Obligations of provider of vital service

(1) The provider of vital service shall ensure the provision of vital service in their area within a specified time, in a specified volume, and at a specified price, broken down by category of food or type of activity, where appropriate.

(2) The detailed requirements for the provision of vital service referred to in subsection 1 of this section shall be laid down by order of the minister in charge of the policy sector.

§ 48. Special measures of state supervision

(1) The law enforcement authority may, for the purpose of exercising the state supervision provided in this Act, take special measures of state supervision provided in §§ 30, 31, 32, 49, 50, 51, 52 and 53 of the Law Enforcement Act on the grounds and in accordance with the rules provided in the Law Enforcement Act.

(2) An expert of the European Commission has the rights specified in subsection 1 of this section upon verification of the compliance of the requirements provided in the legislation of the European Union on the conditions and in accordance with the rules established in the legislation of the European Union.

(3) The law enforcement body applies the measures set out in Article 138 of Regulation (EU) 2017/625 of the European Parliament and of the Council in the event of establishment of the following irregularities:

1) non-compliant food;

2) non-compliant handling of food;

3) non-compliant materials and articles intended to come into contact with food;

4) non-compliant preparation, processing and marketing of materials and articles intended to come into contact with food.

(4) When non-compliant food is and materials and articles intended to come into contact with non-compliant food are brought to Estonia, the law enforcement authority takes the measures provided in Articles 66–69 of Regulation (EU) No 2017/625 of the European Parliament and of the Council.

§ 48¹. Application of rapid alert system and supervision cooperation with Member States of European Union

(1) The Estonian liaison body of the rapid alert system referred to in Article 50 of Regulation (EC) No 178/2002 of the European Parliament and of the Council is the Agriculture and Food Board.

(2) Where it has been established in the course of state supervision that the food is directly or indirectly dangerous for human health and it may be placed on the market in any other Member State of the European Union or where such food has been discovered bringing goods to Estonia, the Tax and Customs Board informs the Agriculture and Food Board of the danger and the latter notifies the European Commission through the rapid alert system specified in subsection 1 of this section.

(3) Where the European Commission has communicated through the rapid alert system referred to in subsection 1 of this section a safety message to the Agriculture and Food Board concerning dangerous food identified in any member state of the European Union, the Agriculture and Food Board forwards this notice to the Tax and Customs Board and the Health Protection Inspectorate. The law enforcement authorities investigate the possible danger in Estonia and inform the Agriculture and Food Board about the results.

(4) The Agriculture and Food Board is the liaison body of supervisory cooperation within the meaning of Article 103(1) of Regulation (EU) No 2017/625 of the European Parliament and of the Council.

(5) Other law enforcement authority, administrative body or government agency notifies the Agriculture and Food Board without delay where there is the following possible violation of the rules in connection with food, including food-related information, the handling of food and materials and articles intended to come into contact with food:

1) a violation that may jeopardise human health or the environment;

2) a violation that has been committed by knowingly creating a misconception of the actual circumstances.

§ 49. Specifics of state supervision

(1) An official of the law enforcement authority has, upon presentation of their identification, the right to verify:

1) the state and use of the establishment or business and its territory, premises, machinery, equipment and means of transport;

2) food ingredients, processing aids and other substances used to prepare food;

3) food, including during the manufacturing process;

4) materials and articles intended to come into contact with food;

5) the equipment, substances and methods of cleaning, disinfection and pest control;

6) food handling, including the methods for processing, manufacturing and storage of food;

7) provision of food information.

(2) In addition to the provisions of subsection 1 of this section, the law enforcement authority has the right to:

1) verify, regardless of whether the medical examination specified in subsection 1 of § 28 of this Act has been undergone, the compliance with hygiene requirements of persons who in the course of their duties come into direct or indirect contact with the items referred to in clauses 2–5 of subsection 1 of this section, including personal cleanliness and clothing, and to assess their knowledge of hygiene;

2) verify the compliance with the requirement to perform self-checking and to examine the results of self-checking and the results of measurements performed by the measuring instruments installed in the establishment or business, as well as to verify the correctness thereof using the measuring instruments of the law enforcement authority.

(3) Where only meat is processed in an establishment or business, the operator is required to provide a workstation, equipment and clothing required for exercising supervision.

(4) Where there is reason to believe that certain food may be harmful to human health or the environment, the head of the appropriate law enforcement authority suspends the handling of such food. The decision is drawn up as a directive of the head of the law enforcement authority, setting out the name of the food and, where necessary, information on the lot concerned, and other information which allows for the identification of the harmful food and the spheres of handling wherein handling must be suspended. The head of the law enforcement authority informs the public of the directive immediately and the information is published on the website of the law enforcement authority.

(5) The head of the law enforcement authority immediately forwards their directive to the minister in charge of the policy sector who decides the suspension of the handling of the food under the circumstances and on the conditions set out in the directive and establish a corresponding regulation. In addition to the information set out in the directive of the head of the law enforcement authority, the regulation must set out the time limit of the restriction, the obligations of law enforcement authorities and persons, and the manner of eliminating the danger. The directive of the head of the law enforcement authority remains in force until entry into force of the regulation of the minister in charge of the policy sector.

(6) While a restriction on handling is in force, the appropriate law enforcement authorities, in cooperation with each other, determine the extent of danger, take necessary measures and, after elimination of the danger, the head of the law enforcement authority who issued the directive makes a written proposal to the minister in charge of the policy sector to terminate the suspension of handling and the minister in charge of the policy sector establishes a corresponding regulation.

(7) Where residential premises are also used as commercial premises, the law enforcement authority may inspect these during the working or opening hours without the authorisation of an administrative court specified in subsection 2 of § 51 of the Law Enforcement Act.

§ 49¹. Food supervision fee

(1) ‘Food supervision fee’ (hereinafter supervision fee) means an amount payable at the rate established in this Act for official controls and other official operations (hereinafter supervision operation) performed for the purpose of checking the compliance of the establishment, food and food handling of an operator that has a notification obligation and a licence obligation and that has performed such obligation. The supervision fee is also payable for performing a supervision operation relating to materials and articles intended to come into contact with food.

(2) The supervision fee is paid for performing a supervision operation related to food in a retail establishment, except for performing a supervision operation related to animal products in an establishment specified in Chapter II of Annex IV to Regulation (EU) 2017/625 of the European Parliament and of the Council.

(3) No supervision fee must be paid for performing a supervision operation relating to primary production.

(4) No supervision fee must be paid by an educational establishment, social establishment or health service provider financed from the budget of a state authority or municipality for performing a supervision operation relating to inter-establishment catering.

§ 49². Person required to pay supervision fee

(1) A person required to pay the supervision fee (hereinafter obligated person) is a person with regard to whom a supervision operation specified in § 49¹ of this Act has been taken.

(2) Multiple obligated persons bear joint and several liability for payment of the supervision fee for a joint supervision operation.

§ 49³. Principles of determination of supervision fee

(1) The costs specified in Article 81 of Regulation (EU) 2017/625 of the European Parliament and of the Council, which are related to the performance of the supervision operations by the Veterinary and Food Board, including to the performance of the veterinary supervision operations specified in subsection 3 of § 84 of the Veterinary Act, serve as the basis for the calculation of the rate of the supervision fee.

(2) The supervision fee is charged as an hourly fee for the supervision operations performed in accordance with § 49¹ of this Act, except for making additional laboratory analyses specified in subsection 9 of this section;

(3) The obligated person must pay an hourly fee for the time spent on performing a supervision operation, but not for more than eight hours per supervision operation. The time spent on a supervision operation is calculated with the accuracy of half-hour. The time spent on driving to the place of performance of the supervision operation is not taken into account.

(4) The costs specified in Article 81 of Regulation (EU) No 2017/625 of the European Parliament and of the Council, which are related to the performance of the food supervision operations of the Agriculture and Food Board serve as the basis for the calculation of the hourly rate. The pay and administrative costs related to food supervision operations, including laboratory analyses and research are calculated on the basis of the actual costs in the calendar year preceding the operation. The total costs related to food supervision operations in the said period are divided by the work hours spent on the supervision operations performed during the same period, except on carrying out laboratory analyses and research.

(4¹) Upon calculation of the administrative costs related to the food supervision operations specified in subsection 4 of this section, the costs of additional laboratory analyses specified in subsection 9 are not taken into account.

(5) The rate of the hourly fee to be charged for performing a supervision operation is established annually by the minister in charge of the policy sector.

(6) In the event of food which, under relevant legislation of the European Union, is subject to supervision at a border control post or at a place of official controls of imported food, the obligated person must pay a supervision fee for supervision operations at an hourly rate per all tariff classifications on one customs declaration.

(7) In the course of performing a food supervision operation, the Agriculture and Food Board has the right to charge an additional fee for the waiting time of a late consignment and a supervision operation performed outside the working time at the request of a person as follows:

1) for the waiting time of a late consignment during the working time, the additional fee is charged as an hourly rate per supervisory official in accordance with subsection 3 of this section;

2) for the waiting time of a late consignment outside the working time and for a supervision operation performed outside the working time at the request of a person, the additional fee is charged as a double hourly rate per supervisory official in accordance with subsection 3 of this section.

(8) The additional fee paid on the basis of subsection 7 of this section is subject to the procedure provided in § 49⁴ of this Act.

(9) In the event specified in Article 79(2)(c) of Regulation (EU) No 2017/625 of the European Parliament and of the Council the obligated person pays a supervision fee for the performance of additional food supervision operations in the form of an hourly fee in accordance with subsection 3 of this section. Where any additional laboratory analyses need to be carried out in connection with an established violation of the rules, the obligated person pays the supervision fee also to the extent of the total costs of these analyses.

§ 49⁴. Payment of supervision fee

(1) The Agriculture and Food Board makes a decision to charge a supervision fee for food supervision operations performed during the previous calendar month by the seventh date of each calendar month.

(2) A decision to charge a supervision fee is communicated to the obligated person electronically within five working days after the day of making the decision where the person has granted consent to such form of communication.

(2¹) In the event specified in subsection 2 of this section a decision to charge a supervision fee is deemed delivered to an obligated person not specified in clauses 3 and 4 of subsection 2 of § 27 of the Administrative Procedure Act where the decision or an extract thereof has been sent to the email address of the obligated person.

(2²) Where the obligated person has not consented to the electronic communication of a decision to charge a supervision fee, the Agriculture and Food Board communicates the decision to the person by delivering a written decision or an extract thereof to the person directly or by post within five working days after making the decision.

(3) The obligated person transfers the supervision fee to the bank account indicated in the decision within 28 days after the day of receipt of the decision to charge the supervision fee.

(3¹) Where the obligated person does not pay the supervision fee within the time limit specified in subsection 3 of this section, the Agriculture and Food Board has the right to submit the decisions to charge the supervision fee for enforcement in accordance with the rules provided in the Code of Enforcement Procedure.

(4) In the event of bringing food to Estonia, the obligated person pays the supervision fee in the amount specified in a decision to collect the supervision fee, which was submitted by the Agriculture and Food Board before the goods are placed under a customs procedure.

(5) Upon bringing food to Estonia, the Agriculture and Food Board may discharge the obligated person from paying the supervision fee before placing the goods under a customs procedure, provided that both of the following criteria are met:

1) the obligated person has presented a sufficient guarantee;

2) the obligated person has previously paid the supervision fee in the prescribed amount and by the due date.

(6) The procedure for payment, receipt in cash and monitoring of payment of the supervision fee is established by a regulation of the minister in charge of the policy sector.

§ 49⁵. Refund of overpaid supervision fee

(1) The Agriculture and Food Board makes a decision to refund an overpaid supervision fee and returns the supervision fee to the obligated person to the extent that it was overpaid (hereinafter overpaid supervision fee) as soon as possible but not later than two months after the date of making the decision to charge the supervision fee.

(2) The obligated person has the right to apply for a refund of an overpaid supervision fee within two years after the day of payment of the supervision fee, provided that the overpaid supervision fee has not been refunded in accordance with subsection 1 of this section.

(3) To apply for a refund of overpaid supervision fee, the obligated person submits to the Agriculture and Food Board a relevant written application and a document certifying payment of the supervision fee.

(4) In an event provided in subsection 3 of this section, the Agriculture and Food Board makes a decision to refund or to refuse to refund the supervision fee within ten working days as of the receipt of the application.

(5) The supervision fee is not refunded where the person who paid the supervision fee or the person for whom the supervision fee was paid cannot be identified or where the person is not entitled to a refund.

(6) The procedure for refunding overpaid supervision fee is established by a regulation of the minister in charge of the policy sector.

§ 51³. Taking and analysis of samples upon performance of official controls and other official operations

(1) Upon checking a movable in the course of performance of official controls and other official operations, samples may be taken at the expense of the person. Where the checked movable is no longer fit for ordinary use following the check, the cost of the movable or the cost of restoring the movable for ordinary use is not compensated to the person.

(2) For the purpose of performing controls over the compliance of food and the handling thereof, the requirements for taking and analysing samples are established per food group or determined indicator by a regulation of the minister in charge of the policy sector.

(4) A person has the right to demand that, in addition to a sample specified in subsection 1 of this section, an additional sample that remains at the disposal of the person is taken at the expense of the person on the same conditions.

(4¹) In the event of a dispute between the Agriculture and Food Board and an operator, which arises from a second expert opinion provided in Article 35 of Regulation (EU) No 2017/625 of the European Parliament and of the Council, the operator may at its own cost request a review of the documents of the initial analysis and, where necessary, have a sample specified in subsection 4 of this section be analysed in a second laboratory specified in Article 37(1) of the Regulation.

(5) Regardless of whether a second expert opinion has been requested, the Agriculture and Food Board takes the necessary measures specified in Article 66 or 138 of Regulation (EU) No 2017/625 of the European Parliament and of the Council.

§ 52. Authorisation of laboratory to analyse samples taken upon performing official controls and other official operations

(1) Samples taken in the course of performance of official controls and other official operations are analysed in a laboratory authorised to conduct relevant analyses (hereinafter authorised laboratory), which complies with the requirements provided in Article 37 of Regulation (EU) No 2017/625 of the European Parliament and of the Council.

(1¹) In events specified in Articles 40 and 42 of Regulation (EU) No 2017/625 of the European Parliament and of the Council, an unaccredited laboratory may be authorised to act as an authorised laboratory.

(2¹) Where it is necessary to authorise a laboratory provided for in Article 37(2) of Regulation (EU) 2017/625 of the European Parliament and of the Council to operate as an authorised laboratory, the Agriculture and Food Board contacts the laboratory for consent and, where consent is received, institutes administrative proceedings to grant authorisation.

(3) The Agriculture and Food Board makes a decision on the granting of authorisation to operate as an authorised laboratory within 30 working days as of the receipt of a written application of the laboratory. In the event of authorisation of a laboratory provided in Article 37(2) of Regulation (EU) 2017/625 of the European Parliament and of the Council, the Agriculture and Food Board makes a decision within 45 working days after the receipt of the relevant laboratory’s consent. In the decision to grant the authorisation to act as an authorised laboratory, the details and description established by Article 37(3) of the same Regulation are given.

(4) The requirements for the content of applications for authorisation to operate as authorised laboratory, the list of documents to be annexed to applications and the procedure for processing applications are established by the minister in charge of the policy sector.

(5) The Agriculture and Food Board may refuse to grant authorisation to operate as an authorised laboratory where the laboratory does not comply with the requirements provided in Articles 37(4) and (5) of Regulation (EU) No 2017/625 of the European Parliament and of the Council.

(5¹) The Agriculture and Food Board revokes the authorisation in the events provided in Article 39(2) of Regulation (EU) No 2017/625 of the European Parliament and of the Council.

(6) A state fee must be paid for reviewing of an application for granting of the initial authorisation for a laboratory in accordance with the rates provided in the State Fees Act.

§ 53. Reference laboratory

(1) For the purposes of this Act, ‘national reference laboratory’ (hereinafter reference laboratory) means the laboratory specified in Article 100 of Regulation (EU) No 2017/625 of the European Parliament and of the Council, which performs the duties of a reference laboratory in the field of food.

(2) A reference laboratory is authorised to operate for each European Union reference laboratory referred to in Article 93(1) of Regulation (EU) No 2017/625 of the European Parliament and of the Council.

(3) Authority to operate as a reference laboratory is granted within 20 working days as of the receipt of a written application of the reference laboratory and by a directive of the minister in charge of the policy sector, which sets out the scope of the authority.

(5) The reference laboratory shall operate on the basis of an action plan submitted to the minister in charge of the policy sector and regularly updated. The implementation of the action plan shall be financed from the funds allocated to the Ministry of Regional Affairs and Agriculture in the state budget.

(6) Where a reference laboratory fails to perform its duties in the manner required, the minister in charge of the policy sector has the right to grant a term of up to three months for the elimination of deficiencies. Where the deficiencies are not eliminated, the authorisation is revoked in part or in full. During the time prescribed for the elimination of deficiencies, the authorisation is deemed to be suspended.

(7) The requirements for the content of applications for authorisation to operate as reference laboratory, the list of documents to be annexed to applications and the procedure for processing applications are established by the minister in charge of the policy sector.

(8) A state fee for reviewing an application for initial authorisation to operate as a reference laboratory must be paid at the rates provided in the State Fees Act.

(9) The minister in charge of the policy sector or a person authorised by the minister may conclude a civil law contract with a laboratory located in a contracting state of the European Economic Area for the purpose of performance of the functions of a reference laboratory in the field of food in Estonia.

(10) In deciding the conclusion of a civil law contract for the purpose of performing the functions of a reference laboratory and in determining the terms and conditions of the contract, the provisions of Articles 100 and 101 of Regulation (EU) 2017/625 of the European Parliament and of the Council and other relevant circumstances are followed.

§ 53¹. Handling food in establishment or business where performance of notification obligation and activity licence are required

(1) The sanction for the commencement of food handling without the authorisation of a supervisory official in an establishment or business that must hold an activity licence for handling food, as well as after any constructional, technological, work organisation or other reorganisations that altered the conditions existing at the time of receipt of an activity licence, as well as food handling in an establishment or business not specified in a notice of economic activities is a fine of up to 300 fine units.

(2) The sanction for the same act committed by a legal person is a fine of up to 3,200 euros.

(3) An attempted misdemeanour specified in this section is penalised.

§ 53². Violation of requirements for food

(1) The sanction for violation of the requirements for food is a fine of up to 200 fine units.

(2) The sanction for the same act committed in a manner that endangers human health or the environment is a fine of up to 300 fine units.

(3) The sanction for the act specified in subsection 1 of this section, which is committed by a legal person, is a fine of up to 2600 euros.

(4) The sanction for the act specified in subsection 2 of this section, which is committed by a legal person, is a fine of up to 3200 euros.

§ 53³. Violation of requirements for handling food and materials and articles intended to come into contact with food

(1) The sanction for violation of the requirements for handling food and materials and articles intended to come into contact with food is a fine of up to 200 fine units.

(2) The sanction for the same act committed by a legal person is a fine of up to 2,000 euros.

§ 53⁵. Violation of requirements for presentation of information

(1) The sanction for violation of the requirements for provision of food information is a fine of up to 150 fine units.

(2) The sanction for the same act committed by a legal person is a fine of up to 1,300 euros.

§ 53⁶. Giving false information about food

(1) The sanction for presentation of false information about the composition or properties of food, the content of food additives, contaminants or micro-organisms in food, or other requirements, or presentation of false information in accompanying documents, sales documents or other certification documents is a fine of up to 250 fine units.

(2) The sanction for the same act committed by a legal person is a fine of up to 2,600 euros.

§ 53⁷. Procedure

(2) The Agriculture and Food Board or a court may, in accordance with the provisions of § 83 of the Penal Code, apply confiscation of a substance or an object which was the direct object of the commission of a misdemeanour provided in subsections 2 and 4 of § 53².

(3) Any out-of-court proceedings of the misdemeanours provided in §§ 53¹–53⁶ of this Act are conducted by:

1) the Agriculture and Food Board.

§ 57

–

§ 62

[Omitted from this text.]

§ 63¹. Notification and approval of establishment where food is handled on 1 July 2006

(1) In accordance with § 7 of this Act, a competent supervision authority is notified not later than by 1 November 2006, of an establishment or business where food is handled on 1 July 2006 and which, as of this date is subject to notification and which has not been approved.

(2) An establishment or business that is subject to notification as of 1 July 2006 but has been approved before such date is deemed to be notified in accordance with § 7 of this Act.

(3) An establishment or business which is subject to approval as of 1 July 2006 which has been approved on the basis of and in accordance with the rules provided by legislation in force until 1 January 2006 is deemed to be approved on the basis of and in accordance with the rules provided by legislation in force as of 1 January 2006.

(4) A decision of temporary approval made before 1 July 2006 is deemed to be the decision of conditional approval within the meaning of subsection 2 of § 10 of this Act.

§ 63². Submission of information about group of materials and articles intended to come into contact with food with regard to such establishment or business whose respective activities have been registered in register of economic activities as of 1 January 2010

In the event of an establishment or business specified in Article 2(2)(c) of Regulation (EC) No 1935/2004 of the European Parliament and of the Council, the undertaking, whose respective activities have been registered in the register of economic activities on the basis of the Trading Act as of 1 January 2010, submits information about the group of materials and articles intended to come into contact with food so that it could be registered in the register of economic activities by 1 June 2010.

§ 63³. Border control post and place of supervision included in list of border control posts and places of supervision over imported food before 1 January 2010

A border control post or a place of supervision included in the list of border control posts and places of supervision over imported food before 1 January 2010 remains in the list until the Veterinary and Food Board has made a decision to exclude the border control post or the place of supervision from the list.

§ 63⁴. Places of performance of official controls

Places of exercises supervision included in the list of border control posts and places of exercising supervision over imported food are considered places of performance of official controls.

§ 65. Reorganisation of work of supervision authorities

(1) The Government of the Republic completes the reorganisation of the work of supervision authorities under this Act by 1 January 2001.

(2) Until reorganisation, supervision authorities perform their current duties, unless otherwise provided by other Acts.

§ 65². Validity of authority of laboratory

The authority to analyse samples taken in course of supervision granted to a laboratory by a directive of the minister in charge of the policy sector before 1 July 2007 is valid until granting new authority or refusal to grant it by the Veterinary and Food Board, but not longer than until 1 January 2008.

§ 65³. Applicability of special requirements for labelling food for particular nutritional uses and provision of information in another manner

The special requirements and procedure for labelling food for particular nutritional uses, including for medical purposes, and for provision of information in another manner, which were established on the basis of the wording of subsection 5 of § 38 of this Act in force until 13 December 2014 remains in force until 20 July 2016.

§ 65⁴. Validity of requirements for the composition and quality of food for particular nutritional uses, requirements for substances used for making food for particular nutritional uses, requirements for handling food for particular nutritional uses, and requirements for provision of food information

(1) Requirements for the composition and quality of food for particular nutritional uses, requirements for substances used for making food for particular nutritional uses, requirements for handling food for particular nutritional uses, and requirements for provision of food information are established by the minister in charge of the policy sector for a term of validity until the date of commencement of application of the legal instrument established on the basis of Article 11(1) of Regulation (EU) No 609/2013 of the European Parliament and of the Council on the conditions provided in the same legal instrument.

(2) Upon establishment of the requirements provided in subsection 1 of this section, the purpose of use of the food for special nutritional uses and the special characteristics of the food groups are taken into account.

§ 65⁵. Notification of infant formula, food for special medical purposes and food for special nutritional uses with very low energy content

Notification of placing an infant formula, food for special medical purposes and food for special nutritional uses with very low energy content on the market for the first time is subject to the wording of subsections 5¹ and 5³ of § 14 of the Food Act in force until 19 July 2016. It is applied until the date of commencement of application of the legal instrument established on the basis of Article 11(1) of Regulation (EU) No 609/2013 of the European Parliament and of the Council on the conditions provided in the same legal instrument.

§ 65⁶. Application of hourly rate

Until 31 December 2019, an hourly fee is charged for performing food supervision operations at the rate set for 2019 in subsection 5 of § 49³ of this Act.

§ 65⁷. Notification obligation of establishment where food handling licence obligation is replaced with notification obligation as of 1 April 2021

The notification obligation of an operator holding a licence to handle food in an establishment whereby the licence obligation is replaced with the notification obligation as of 1 April 2021 is deemed fulfilled.

§ 65⁸. Obligation to obtain a permit for the treatment of food with ionising radiation for an operator who has used a method of treatment of food with ionising radiation permitted by the Agriculture and Food Board before 1 July 2024

An operator who, with the permission of the Agriculture and Food Board, has used a method of treatment of food with ionising radiation before 1 July 2024 shall be deemed to have fulfilled the obligation to obtain a permit for the treatment of food with ionising radiation provided for in subsection 1 of § 21¹of this Act.

§ 66. Entry into force of Act

(1) This Act enters into force on 1 January 2000, except the provisions delegating authority, which enter into force at the time provided in subsection 2 of this section, and § 34 and subsection 2 of § 52 which enter into force on 1 January 2002, and subsection 1 of § 52 which enters into force on 1 July 2000.

(2) The provisions which delegate authority to issue regulations of the Government of the Republic or ministers and which are contained in this Act enter into force on the tenth day after the publication of the Act in the Riigi Teataja. A regulation issued on the basis of provisions delegating authority is not enforced before the entry into force of this Act.