
Article 1 

1. This Regulation shall apply to consignments of the food of non-animal origin which is listed in Annex I.This Regulation shall also apply to compound food, containing any of the food listed in Annex I in a quantity above 20 %.
2. This Regulation shall not apply to consignments of food which are destined to a private person for personal consumption and use only. In case of doubt, the burden of proof lies with the recipient of the consignment.
Article 2 
For the purposes of this Regulation, the definitions laid down in Articles 2 and 3 of Regulation (EC) No 178/2002 and in Article 2 of Regulation (EC) No 882/2004 shall apply.
The definitions of ‘common entry document’ and ‘designated point of entry’ set out in points (a) and (b) respectively of Article 3 of Regulation (EC) No 669/2009 shall also apply.
For the purposes of this Regulation, a ‘consignment’ means a ‘lot’ as defined in Directive 2002/63/EC.
For the purposes of Article 11(3), the definitions set out in Regulation (EC) No 396/2005 shall apply.
Article 3 
Consignments of food referred to in Article 1(1) may only be imported into the Union in accordance with the procedures laid down in this Regulation.
Such consignments can only enter the Union through a designated point of entry.
Article 4 

1. Each consignment of food referred to in Article 1(1) shall be accompanied by the results of sampling and analysis performed by the competent authorities of the country of origin as referred to in Annex I or of the third country where the consignment is consigned from if that country is different from the country of origin, to ascertain compliance with Union legislation on maximum residue levels of pesticides.
2. The sampling referred to in paragraph 1 must be performed in accordance with Directive 2002/63/EC.
3. The analysis referred to in paragraph 1 must be performed by laboratories accredited in accordance with the standard ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’.
Article 5 

1. Each consignment of food referred to in Article 1(1) shall be accompanied by the original version of a health certificate, in accordance with the model set out in Annex II.
2. The health certificate shall be completed, signed and verified by the competent authority of the country of origin or of the country where the consignment is consigned from if that country is different from the country of origin.
3. The health certificate shall be drawn up in the official language, or in one of the official languages, of the Member State where the designated point of entry is located. However, a Member State may consent to health certificates being drawn up in another official language of the Union.
4. The health certificate must be issued before the consignment to which it relates leaves the control of the competent authority issuing it.
5. The health certificate shall only be valid during four months from the date of issue.
6. The original health certificate shall be presented to, and kept by, the competent authorities of the designated point of entry.
Article 6 
Each consignment of food referred to in Article 1(1) shall be identified with an identification code which corresponds to the identification code mentioned on the results of the sampling and analysis referred to in Article 4 and the health certificate referred to in Article 5. Each individual bag, or other packaging form, of the consignment shall be identified with that identification code.
Article 7 

1. Food business operators or their representatives shall give prior notification of the estimated date and time of physical arrival of consignments of food referred to in Article 1(1) to the competent authorities at the designated point of entry and of the nature of the consignment.
2. For the purpose of prior notification, food business operators or their representatives shall complete Part I of the common entry document (CED) and transmit that document to the competent authorities at the designated point of entry, at least one working day prior to the physical arrival of the consignment.
3. For the completion of the CED pursuant to this Regulation, food business operators or their representatives shall take into account the notes for guidance for the CED laid down in Annex II to Regulation (EC) No 669/2009.
Article 8 

1. The competent authorities at the designated point of entry shall carry out documentary checks in relation to each consignment of food referred to in Article 1(1) to ascertain compliance with the requirements laid down in Articles 4 and 5.
2. Member States shall carry out identity and physical checks on consignments, including sampling and analysis, in accordance with Articles 8(1), 9 and 19 of Regulation (EC) No 669/2009 at the frequency set out in Annex I to this Regulation.
3. After completion of the checks, the competent authorities shall:
(a) complete the relevant entries of Part II of the CED;
(b) join the results of sampling and analysis carried out in accordance with paragraph 2 of this Article to the CED;
(c) provide and fill the CED reference number on the CED;
(d) stamp and sign the original of the CED;
(e) make and retain a copy of the signed and stamped CED.
4. The competent authorities of the designated point of entry shall issue the operator responsible for the consignment with an authenticated copy of the health certificate or, if the consignment is split, with individually authenticated copies of such certificate.
5. The original of the CED shall accompany the consignment during its transport until it is released for free circulation.
Article 9 

1. The consignment shall not be split until all official controls have been completed, and the CED has been fully completed by the competent authorities as provided for in Article 8.
2. In the case of subsequent splitting of the consignment, an authenticated copy of the CED shall accompany each part of the consignment during its transport until it is released for free circulation.
Article 10 
The release for free circulation of consignments shall be subject to the presentation by the food business operators or their representative to the custom authorities of a CED duly completed by the competent authority once all official controls have been carried out. The custom authorities shall only release the consignment for free circulation if a favourable decision by the competent authority is indicated in box II.14 of the CED and the CED is signed in box II.21 thereof.
Article 11 

1. Where the official controls carried out in accordance with Article 8 establish non-compliance with the relevant Union legislation, including this Regulation, the competent authority shall complete Part III of the CED and action shall be taken pursuant to Articles 19, 20 and 21 of Regulation (EC) No 882/2004.
2. Where a consignment is not accompanied by both the results of sampling and analysis referred to in Article 4 and the health certificate referred to in Article 5 or if those results or that health certificate do not comply with the requirements laid down in this Regulation, the consignment shall not be imported into the Union and shall be re-dispatched outside the Union or destroyed.
3. Where the competent authority at the designated point of entry does not permit the introduction of a consignment of food referred to in Article 1(1) due to non-compliance with a maximum residue level set out in Regulation (EC) No 396/2005, it shall immediately notify such border rejection in accordance with Article 19(3) of Regulation (EC) No 882/2004.
Article 12 

1. Member States shall submit to the Commission biannually, by the end of the month following each semester, a report of all analytical results of official controls carried out on consignments of food pursuant to this Regulation.That report shall include the following information:
(a) the number of consignments imported;
(b) the number of consignments subjected to sampling for analysis;
(c) the results of the checks as provided for in Article 8(2).
2. The reporting obligations set out in paragraph 1 shall be deemed to be satisfied where Member States register in TRACES the CEDs issued by their respective competent authorities in accordance with this Regulation.
Article 13 
This Regulation shall be reviewed before 31 October 2019.
Article 14 
All costs resulting from the official controls including sampling, analysis, storage and any measures taken following non-compliance shall be borne by the food business operators responsible for the consignment.
Article 15 
Annex I to Regulation (EC) No 669/2009 is amended as follows:

((a)) in the entries for Turkey, the entry referring to ‘Vine leaves’ is deleted.
((b)) in the entries for Vietnam, the entry referring to ‘Pitahaya (dragon fruit)’ is deleted.
Article 16 
Implementing Regulation (EU) No 885/2014 is repealed.
Article 17 
For a period of three months from the date of entry into force of this Regulation, Member States shall continue to authorise the introduction of consignments of curry leaves originating from India which left the country of origin, or the country of consignment if that country is different from the country of origin, prior to 8 December 2018 provided that those consignments fulfil the requirements of Implementing Regulation (EU) No 885/2014.
For a period of three months from the date of entry into force of this Regulation, Member States shall continue to authorise the introduction of consignments of vine leaves originating from Turkey and of Pitahaya (dragon fruit) originating from Vietnam which left the country of origin, or the country of consignment if that country is different from the country of origin, prior to 8 December 2018 provided that those consignments fulfil the requirements of Regulation (EC) No 669/2009 in force on 7 December 2018.
Article 18 
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 8 December 2018.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 7 November 2018.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX I

Food (intended use) CN code TARIC sub-division Country of origin Hazard(s) Frequency of physical and identity checks (%) at import
Pitahaya (dragon fruit)(Food — fresh or chilled) ex 0810 90 20 10 Vietnam (VN) Residues of pesticides listed in the control programme adopted in accordance with Article 29(2) of Regulation (EC) No 396/2005 (pesticides to be monitored in/on products of plant origin only) and residues of dithiocarbamates (dithiocarbamates expressed as CS2, including maneb, mancozeb, metiram, propineb, thiram and ziram), Phenthoate and Quinalphos. 10
Curry leaves (Bergera/Murraya koenigii)(Food — fresh, chilled, frozen or dried) ex 1211 90 86 10 India (IN) Residues of pesticides listed in the control programme adopted in accordance with Article 29(2) of Regulation (EC) No 396/2005 (pesticides to be monitored in/on products of plant origin only) and residues of acephate. 20
Vine leaves(Food) ex 2008 99 99 11, 19 Turkey (TR) Residues of pesticides listed in the control programme adopted in accordance with Article 29(2) of Regulation (EC) No 396/2005 (pesticides to be monitored in/on products of plant origin only) and residues of dithiocarbamates (dithiocarbamates expressed as CS2, including maneb, mancozeb, metiram, propineb, thiram and ziram) and metrafenone. 20



ANNEX II



