SANTE/10674/2019-EN ANNEX CIS

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[1].

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,

- 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

- fur animals.

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 shall be subject to serological sampling on a monthly basis, with the exception of registered horses as defined in Article 2(c) of Commission Implementing Regulation (EU) 2018/659[2], 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 the 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, when 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;

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[3].

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 or has not altered the guaranteed conditions provided in official certificate or document 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

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 paragraph 3 as follows:

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

(b) the selection of samples for examination mentioned in points (a) and (b) of paragraph 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 (b) and (c) of paragraph 3 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 the second subparagraph of Article 4(4), 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 substances to be tested, and shall carry out the laboratory tests referred to in point 3(c) in accordance with that plan.

Such monitoring plan shall be based on a risk assessment, 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 feed and food 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 feed and food business operators or their representatives to predict whether any particular consignment will be subjected to such checks;

(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 ... of Commission Delegated Regulation 2019/XXX[4] [pursuant to Article 51 (1) (a) of Regulation (EU) 2017/625].

Annex III

Detailed rules on the operations to be carried out during physical checks on goods referred to in Article 4(5)

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[5], shall be identified on the basis of the following elements, as presented in the official phytosanitary certificate:

- origin,

- 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,

- type of processing.

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 Article 6(4) of Commission Implementing Regulation (EU) …/…[6] [Implementing Regulation adopted under Article 54(3)(a) and (c) of Regulation (EU) 2017/625 – frequency of checks]:

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:

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;

[1] Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 (OJ L 3, 5.1.2005, p. 1).

[2] Commission Implementing Regulation (EU) 2018/659 of 12 April 2018 on the conditions for the entry into the Union of live equidae and of semen, ova and embryos of equidae (OJ L 110, 30.4.2018, p. 1).

[3] Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 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, p. 18).

[4] Commission Delegated Regulation (EU) …/... of XXX 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 (OJ L …., … …. .2019, p. ….).

[5] Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (OJ L 317, 23.11.2016, p. 4.).

[6] Commission Implementing Regulation (EU) …/... of … establishing rules for the uniform application of frequency rates for identity checks and physical checks on certain consignments of animals and goods entering the Union (OJ L …, … 2019, p. …).