Commission Implementing Regulation (EU) 2019/2130

Contents

THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation)^note, and in particular Article 52 thereof,Whereas:

(1)Regulation (EU) 2017/625 establishes the rules for the competent authorities of Member States when they perform official controls on animals and goods entering the Union in order to verify compliance with the Union agri-food chain legislation.

(2)Pursuant to Regulation (EU) 2017/625, consignments of the categories of animals and goods referred to in its Article 47(1) are subject to official controls at border control posts for official controls, unless they are exempted from such controls on the basis of Article 48 of that Regulation. Those official controls are to include documentary checks, identity checks and physical checks. For the purpose of ensuring the uniform implementation of Articles 49, 50 and 51 of Regulation (EU) 2017/625 and the efficient performance of official controls on the categories of animals and goods referred to above, detailed rules concerning the performance of documentary checks, identity checks and physical checks at border control posts should be laid down in this Regulation.

(3)The rules on the operations to be carried out during and after documentary checks, identity checks and physical checks at the border control posts of arrival or control points should also apply to certain categories of food and feed of non-animal origin subject to a temporary increase of controls, other conditions of entry into the Union and emergency measures provided for by the acts referred to in points (d), (e) and (f) of Article 47(1) of Regulation (EU) 2017/625.

(4)The operations carried out during documentary checks, identity checks and physical checks before the date of application of this Regulation have proven to be effective and ensure a high level of performance of checks. Therefore, the rules laid down in this Regulation should be based on the same principles as the requirements for the performance of documentary checks, identity checks and physical checks laid down in Council Directives 91/496/EEC^note, 97/78/EC^note and 2000/29/EC^note, Commission Regulations (EC) No 136/2004^note and (EC) No 282/2004^note and Commission Decision 97/794/EC^note.

(5)All relevant documents which are required to accompany consignments of the categories of animals and goods referred to in Article 47(1) of Regulation (EU) 2017/625 should be checked to ensure that they are based on the relevant model document, that the general certification requirements are fulfilled and that they provide the guarantees required under Union legislation or applicable national rules.

(6)When consignments of certain categories of goods referred to in Article 47(1) of Regulation (EU) 2017/625 enter the Union, Union legislation provides that laboratory analyses, tests or diagnoses are to be carried out or that the means of transport are to be sealed to ensure a high level of consumer protection and to prevent any risk for public, animal and plant health. In such cases, the results of the laboratory analyses, tests or diagnoses or the seal numbers should be recorded in the Common Health Entry Document (CHED).

(7)To ensure traceability of the animals and goods entering the Union, the original and, where applicable, the copy of the official certificates or documents should be kept for a certain period at the border control post of arrival into the Union.

(8)Since this Regulation lays down provisions in the areas covered by Regulations (EC) No 136/2004 and (EC) No 282/2004 and Decision 97/794/EC, these acts should be repealed with effect from the date of application of this Regulation.

(9)Regulation (EU) 2017/625 applies from 14 December 2019. Accordingly, the rules laid down in this Regulation should also apply from that date.

(10)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1Subject matter and scope#

This Regulation lays down detailed rules on the operations to be carried out during and after the documentary checks, identity checks and physical checks referred to in Articles 49, 50 and 51 of Regulation (EU) 2017/625 on consignments of the categories of animals and goods referred to in Article 47(1) of that Regulation.

Article 2Detailed rules for documentary checks#

1.For each consignment of animals and goods referred to in Article 1, the competent authority shall ascertain the use to which the animals and goods are assigned pursuant to the official certificates, official attestations and other documents accompanying the consignment as well as the destination of the consignment indicated in these certificates, attestations and documents.

2.The competent authority shall inspect all official certificates, official attestations and other documents referred to in point (41) of Article 3 of Regulation (EU) 2017/625 or their electronic equivalents submitted in the information management system for official controls (IMSOC) referred to in Article 131 of that Regulation or via existing national systems in order to ascertain that:

(a)they are issued by the competent authority of the third country, where applicable;

(b)they fulfil the requirements set out in Articles 89(1) and 91(2) of Regulation (EU) 2017/625 and in the implementing acts referred to in Article 90 of that Regulation;

(c)they correspond to the model established by the rules referred to in Article 1(2) of Regulation (EU) 2017/625;

(d)the information contained in the certificates or documents complies with the rules referred to in Article 1(2) of Regulation (EU) 2017/625

3.The competent authority shall check that the operator responsible for the consignment completed the relevant part of the Common Health Entry Document (CHED) fully and correctly as required by Article 56(1) of Regulation (EU) 2017/625 and that the information in it corresponds to the information provided in the official certificates, official attestations and other documents accompanying the consignment.

Article 3Detailed rules for identity checks#

1.During identity checks on consignments of animals and goods referred to in Article 1, the competent authority shall verify that the following elements correspond to the information provided in the official certificates, official attestations and other documents accompanying the consignments:

(a)the number of animals, their species, breed, sex, age and category, where applicable;

(b)the content of the consignments;

(c)the quantity of the consignments;

(d)the appropriate stamps and identification marks or codes, where applicable;

(e)the identification of the means of transport, where applicable;

(f)seals on containers or means of transport, where applicable.

2.For consignments of products of animal origin, germinal products, animal by-products, derived products, hay and straw and composite products, the identity checks may be limited to points (e) and (f) of paragraph 1 in the cases where:

(a)the consignments are not selected for physical checks;

(b)the consignments have been loaded in transport units which are closed and locked by a seal;

(c)seals on containers or means of transport are intact and not tampered with;

(d)the seals on containers or means of transport were fixed by or under the supervision of the competent authority issuing the official certificate; and

(e)the information available on seals corresponds to that given in the accompanying official certificate required by the rules referred to in Article 1(2) of Regulation (EU) 2017/625.

3.For consignments of products of animal origin, germinal products, animal by-products, derived products, hay and straw and composite products, the selection of items or packages for identity checks shall cover 1 % of the items or packages in a consignment, with a minimum of two and up to a maximum of 10 items or packages. Where, on the basis of selected items or packages the competent authority is not able to complete the identity check, the number of items or packages checked may be increased to perform more extensive checks and may reach the total number of items or packages in the consignment concerned.

4.For consignments of animals, identity checks shall be based on the following rules:

(a)for animals for which individual identification is required by Union legislation, at least 10 % of the animals with a minimum of 10 animals shall be selected from the consignment so as to constitute a representative sample. Where the consignment contain less than 10 animals, the identity checks shall be carried out on each animal in the consignment;

(b)for animals for which individual identification is not required by Union legislation, the marking shall be checked of a representative number of packages or containers;

(c)if the identity checks laid down in points (a) and (b) have not been satisfactory, the number of animals checked shall be increased and may reach the total number of animals in the consignment concerned.

5.Consignments shall be partially or fully unloaded from the means of transport where it is necessary to have full access to the whole consignment for the purpose of identity checks.

Article 4Detailed rules for physical checks#

1.During physical checks on consignments of animals and goods referred to in Article 1, the competent authority shall verify that the consignments comply with the rules referred to in Article 1(2) of Regulation (EU) 2017/625 applicable to the particular animals or goods and the specific requirements defined in the relevant official certificates, official attestations and other documents.

2.Consignments shall be partially or fully unloaded from the means of transport where it is necessary to have access to the whole consignment for the purpose of physical checks.

3.Physical checks on animals shall be carried out in accordance with the requirements set out in Annex I to this Regulation.

4.Physical checks on products of animal origin, germinal products, animal by-products, derived products, hay and straw and composite products and on food and feed of non-animal origin subject to temporary increase of controls, other conditions of entry into the Union and emergency measures provided for by the acts referred to in points (d), (e) and (f) of Article 47(1) of Regulation (EU) 2017/625 shall be carried out in accordance with the requirements set out in Annex II to this Regulation.

5.Laboratory tests to detect hazards on products of animal origin, germinal products, animal by-products, derived products, hay and straw and composite products shall be carried out in accordance with the monitoring plan referred to in point 5 of Annex II.

6.Physical checks on plants, plant products and other objects referred to in point (c) of Article 47(1) of Regulation (EU) 2017/625 and, where applicable, subject to emergency measures provided for in the acts referred to in point (e) of Article 47(1) of that Regulation shall be carried out in accordance with the requirements set out in Annex III to this Regulation.

7.The following consignments of animals may be placed on the market before the results of laboratory tests carried out during physical checks are available:

(a)consignments of ungulates sampled in line with sampling requirements referred in part III of Annex I, where no immediate danger to public health or animal health is suspected from those ungulates; and

(b)consignments of other animals referred to in point (a) of Article 47(1) of Regulation (EU) 2017/625, where no immediate danger to public health or animal health is suspected from those animals.

8.Consignments of goods tested pursuant to the monitoring plan referred to in paragraph 5, for which no immediate danger to public health or animal health is suspected, may be placed on the market before the laboratory test results are available.

9.Where consignments of plants, plant products and other objects referred to in point (c) of Article 47(1) of Regulation (EU) 2017/625 are sampled for laboratory analysis during physical checks and no immediate danger to plant health is suspected, such consignments may be placed on the market before the laboratory test results are available.

Article 5Operations to be carried out after documentary checks, identity checks and physical checks#

1.After completion of the checks provided for in Article 49(1) of Regulation (EU) 2017/625, the competent authority shall:

(a)close and identify with an official mark the packages which it has opened for the purpose of identity checks or physical checks;

(b)in the cases required by Union legislation, seal the means of transport and enter the seal number in the CHED.

2.The competent authorities shall record in the CHED all the results of laboratory analyses, tests or diagnoses, as soon as they are available, of consignments which have been tested and placed on the market before laboratory test results are available.

3.The original official certificates or documents, or electronic equivalents, referred to in Article 50(1) of Regulation (EU) 2017/625 shall be kept by the competent authority of the border control post of arrival into the Union for at least three years from the date on which the consignments were authorised to enter the Union.However, the original certificate or documents for the plants, plant products and other objects referred to in point (c) of Article 47(1) of Regulation (EU) 2017/625 may be kept by means of electronic storage of information provided that such information is generated by the competent authority on the basis of the original certificate or documents. In such cases, the original certificate or document shall be invalidated or destroyed by the competent authority.

4.Where the rules referred to in Article 1(2) of Regulation (EU) 2017/625 do not require original certificates or documents to be presented to, and kept by, the competent authority, a copy of the original official certificate or documents referred to in Article 50(1) of Regulation (EU) 2017/625 shall be kept by the competent authority of the border control post of arrival into the Union for at least three years from the date on which the consignments were authorised to enter the Union or for onward travel in paper or electronic format.

Article 6Repeals#

1.Regulation (EC) No 282/2004 and Decision 97/794/EC are repealed with effect from 14 December 2019.

2.Regulation (EC) No 136/2004 is repealed with effect from 14 December 2019.However, Article 9 of Regulation (EC) No 136/2004 shall continue to apply until 20 April 2021 in respect of the list of countries authorised and listed in Annex V to that Regulation.

Article 7Entry into force and date of application#

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.It shall apply from 14 December 2019.

Annex I · Detailed rules on the operations to be carried out during physical checks on animals referred to in Article 4(3)

I. Inspection regarding fitness of the animals for further transport

1.An overall assessment of all animals shall be made by visual inspection to assess their fitness for further transport, taking into account the length of the journey already undertaken, including feeding, watering and resting arrangements that had been provided. Account shall be taken of the length of the journey that remains to be undertaken including the proposed feeding, watering and resting arrangements during this part of journey.

2.The means of transport of the animals and the journey log shall be checked for compliance with Council Regulation (EC) No 1/2005^note.

II. Clinical examination

1.The clinical examination of the animals shall consist of a visual examination of all animals and shall comprise of at least the following:

(a)a visual examination of the animals, including an overall assessment of their health status, their ability to move freely, the condition of their skin and mucosae and any evidence of abnormal discharges;

(b)monitoring of the respiratory and alimentary systems;

(c)random monitoring of the body temperature in cases when abnormalities have been detected in accordance with points (a) or (b);

(d)palpation in cases when abnormalities have been detected in accordance with points (a), (b) or (c).

2.Consignments of animals intended for breeding or production shall be subject to clinical examination of at least 10 % of the animals with a minimum of 10 animals, which shall be selected so as to be representative of the whole consignment. Where the consignment contains less than 10 animals, the checks shall be carried out on each animal in the consignment.

3.Consignments of animals intended for slaughter shall be subject to clinical examination of at least 5 % of the animals with a minimum of five animals, which shall be selected so as to be representative of the whole consignment. Where the consignment contains less than five animals, the checks shall be carried out on each animal in the consignment.

4.The number of animals checked in accordance with points 2 and 3 shall be increased and may reach the total number of animals in the consignment concerned, if the physical checks carried out have not been satisfactory.

5.The animals listed below shall not be subject to individual clinical examination:

—poultry,

—fur animals.

—birds,

—aquaculture animals and all live fish,

—rodents,

—lagomorphs,

—bees and other insects,

—reptiles and amphibians,

—other invertebrates,

—certain zoo and circus animals, including ungulates, considered to be dangerous,

6.For the animals listed in point 5, clinical examination shall consist of observation of the state of health and behaviour of the entire group or of a representative number of animals. If the above mentioned clinical examination reveals an anomaly, a more thorough clinical examination shall be carried out, including sampling, where appropriate.

7.In case of live fish, crustaceans and molluscs, and animals destined for scientific research centres and having a certified specific health status, which are transported in sealed containers under controlled environmental conditions, a clinical examination and sampling shall be carried out only where it is considered that a specific risk may exist because of the species involved or because of their origin, or where there are other irregularities.

III. Sampling procedure of ungulates

1.Concerning consignments of ungulates, sampling with a view to checking compliance with the health requirements laid down in the accompanying official certificates or documents, or electronic equivalents, shall be undertaken as follows:

(a)At least 3 % of the consignments that have arrived each month at the border control post shall be subject to serological sampling, with the exception of registered horses as defined in Article 2(c) of Commission Implementing Regulation (EU) 2018/659^note, and shall be accompanied by an individual health certificate attesting compliance with the animal health requirements set out in that Implementing Regulation. At least 10 % of the animals in each consignment shall be sampled, with a minimum of four animals. Should the competent authority have reasons to suspect that this sampling is not conclusive, that percentage shall be increased and may reach the total number of animals in the consignment concerned.

(b)Following a risk assessment by the official veterinarian or where provided for in Union legislation, the necessary samples may be taken from any animal in a consignment presented for official controls.

(c)The necessary laboratory tests, performed with a view to verifying compliance with animal health requirements or, where appropriate, the existence of residues and contaminants, shall be carried out without delay.

Annex II · Detailed rules on the operations to be carried out during physical checks on goods referred to in Article 4(4)

1.The competent authority shall carry out physical checks to verify:

(a)that the transport conditions ensured the proper preservation of the goods taking into account their purpose;

(b)that the temperature range during transport required by Union legislation was maintained and there were no shortcomings or breaks in the cold chain, by means of examination of records of temperature range during transport;

(c)the integrity of the packaging material.

2.The competent authority shall carry out physical checks to verify that the labelling of the ‘use by’ date complies with Regulation (EU) No 1169/2011 of the European Parliament and of the Council^note.The competent authority may carry out physical checks to verify that the labelling complies with other requirements laid down in the rules referred to in Article 1(2) of Regulation (EU) 2017/625.

3.The competent authority shall verify that the goods are fit to be used for the intended purpose and that their properties have not changed during transport, by means of:

(a)sensory examination of the smell, colour, consistency or taste of the goods; or

(b)simple physical or chemical tests by cutting, defrosting or cooking the goods; or

(c)laboratory tests.

4.In respect of consignments of products of animal origin, germinal products, animal by-products, derived products, hay and straw and composite products, the competent authority shall carry out the operations referred to in point 3 as follows:

(a)a selection of items or packages, or samples in the case of bulk products, shall be collected before carrying out the operations referred to in point 3;

(b)the selection of samples for examination mentioned in points (a) and (b) of point 3 shall cover 1 % of the items or packages in a consignment, with a minimum of two items or packages and up to a maximum of 10 items or packages. If necessary, the competent authority may increase the number of items or packages checked to perform more extensive checks;

(c)the tests referred to in points 3(b) and (c) shall be carried out on a range of samples selected so as to be representative of the entire consignment.

5.For the purposes of implementation of Article 4(5), the competent authority shall develop a monitoring plan, with the objective of monitoring the conformity with the rules referred to in Article 1(2) of Regulation (EU) 2017/625, and in particular of detecting hazards by indicating the goods to be examined and the testing to be carried out, and shall carry out the laboratory tests referred to in point 3(c) in accordance with that plan.Such monitoring plan shall be risk-based taking into account all relevant parameters, such as the nature of the goods, the risk they represent, the frequency and number of incoming consignments and the results of previous monitoring.

6.In respect of consignments of food and feed of non-animal origin subject to measures provided for in the acts referred to in points (d), (e) and (f) of Article 47(1) of Regulation (EU) 2017/625, the competent authority shall carry out physical checks in accordance with the following rules:

(a)physical checks shall include laboratory tests in accordance with the acts referred to in points (d), (e) and (f) of Article 47(1) of Regulation (EU) 2017/625;

(b)physical checks shall be carried out in such a way that it is not possible for food and feed business operators or their representatives to predict whether any particular consignment will be subjected to such checks;

(c)the results of physical checks shall be available as soon as technically possible;

(d)the consignments tested must be placed under official detention pending the outcome of laboratory tests, unless onward transportation to the place of final destination is authorised by the competent authority at the border control post in accordance with Article 4 of Commission Delegated Regulation 2019/2124^note.

III · Detailed rules on the operations to be carried out during physical checks on plants, plant products and other objects referred to in Article 4(6)

1.The competent authority shall carry out physical checks of consignments and their lots in their entirety or on representative samples. Homogenous lots in the consignment shall be identified based on the information provided in the official phytosanitary certificate and taking into account the elements referred to in point 2.

2.The homogeneity of a lot within the meaning of Article 2(7) of Regulation (EU) 2016/2031 of the European Parliament and of the Council^note, shall be identified on the basis of the following elements, as presented in the official phytosanitary certificate:

—origin,

—type of processing.

—grower,

—packing facility,

—type of packaging,

—genus, species, variety, or degree of maturity,

—exporter,

—area of production,

—regulated pests and their characteristics,

—treatment at origin,

3.Sampling of lots in a consignment shall include the identification of the appropriate independent unit for sampling. In the case of certain plants or plant products, the unit shall be identified as follows:

—fruit in the botanical sense: 1 fruit,

—cut flower: 1 stem,

—foliage, leafy vegetable: 1 leaf,

—tubers, bulbs, rhizomes: 1 tuber or bulb or rhizome,

—plants intended for planting: 1 plant,

—branches: 1 branch,

—wood and bark: to be determined on a case by case basis, with the smallest piece weighing not less than 1 kg,

—seed: one seed.

When the unit is not definable because of the size, shape or way of packaging, the smallest package unit shall be defined as the sampling unit.

4.Sampling for physical checks performed by visual inspection shall be carried out under the following sampling schemes depending on the goods and as referred to in the relevant table of the International Standards for Phytosanitary Measures No 31 Methodologies for sampling of consignments (ISPM31):

(a)rooted non-dormant plants for planting:sampling scheme able to identify with 95 % reliability a level of presence of infected plants of 1 % or above;

(b)dormant plants for planting including tubers, bulbs and rhizomes:sampling scheme able to identify with 95 % reliability a level of presence of infected plants of 2 % or above;

(c)seeds or plant products that comply with the specific conditions listed in Articles 3 and 4 of Commission Regulation (EC) No 1756/2004^note:sampling scheme able to identify with 80 % reliability a level of presence of infected plants of 5 % or above;

(d)unrooted cuttings, plants, plant products and other objects, not falling under points (a), (b) and (c):sampling scheme able to identify with 95 % reliability a level of presence of infected plants of 5 % or above;

(e)lots of seeds and leafy vegetables of less than or equal to 500 units:hypergeometric sampling scheme able to identify with 95 % reliability a level of presence of infected plants of 10 % or above.

5.Any measure taken in response to non-compliance shall be related to the lot as identified ahead of the physical checks.

6.A minimum amount of samples for laboratory tests shall be taken for latent infection detection concerning plants for planting according to a risk analysis, in accordance with the following criteria:

(a)the history of the level of Union quarantine pests intercepted and notified by the Member States, according to point (c) of the first paragraph of Article 11 of Regulation (EU) 2016/2031, including priority pests, as defined in Article 6(1) of that Regulation, of a third country of origin;

(b)the occurrence of a priority pest in the third country of origin, according to available scientific information;

(c)information available via the IMSOC.