Date: 2020-06-18Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Regulation (EU) 2020/797 of 17 June 2020 amending Regulation (EU) No 142/2011 as regards requirements for animal by-products and derived products originating from, and returning to, the Union following refusal of entry by a third country (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Regulation (EU) 2020/797 amends Regulation (EU) No 142/2011 regarding animal by-products and derived products originating from, and returning to, the Union following refusal of entry by a third country. It establishes specific requirements for the re-entry of such products to ensure appropriate animal and public health risk management. The regulation applies from 14 December 2019.
Key Points / Main Content:
* **Amendment of Regulation (EU) No 142/2011:**
* Article 25 is amended to include specific requirements for animal by-products and derived products originating from, and returning to, the Union following refusal of entry by a third country.
* Article 26 is amended to state that materials originating from a Member State and returning to that Member State following a refusal of entry by a third country, must comply with the specific requirements set out in Chapter VI of Annex XIV.
* Article 31 is amended to state that animal byproducts and derived products originating from, and returning to, the Union following a refusal of entry by a third country, must comply with the specific requirements set out in Chapter VI of Annex XIV, by way of derogation from the first paragraph.
* Annex XIV is amended to include Chapter VI, which sets out requirements for the entry of consignments of animal by-products and derived products originating from, and returning to, the Union following refusal of entry by a third country.
* **Requirements for Unpackaged/Bulk Products (Third Country Not Listed in Annex XIV):**
* Entry is authorized if the consignment is accompanied by the official certificate or document (original or authenticated copy) or electronic equivalent (IMSOC) issued by the exporting Member State.
* A declaration from the destination Member State's competent authority agreeing to receive the consignment and indicating the destination is required.
* The consignment must have remained sealed with an intact original seal (if applicable) and be accompanied by an official declaration from the refusing third country stating the reason for refusal.
* If exported without an official certificate/document, the origin must be authenticated by documented evidence from the responsible operator.
* Transport from the border control post to the destination must be monitored according to Commission Delegated Regulation (EU) 2019/1666.
* **Requirements for Unpackaged/Bulk Products (Third Country Listed in Annex XIV):**
* The requirements are the same as for non-listed countries, with the addition of specific conditions if products were unloaded, stored, or reloaded in the third country.
* If products were unloaded, stored, or reloaded, an official declaration from the third country's authority is required, indicating place/date, seal number after reloading, confirmation of seal integrity (broken only for official controls), handling procedures (temperature, cross-contamination prevention), and reasons for unloading/storage.
* **Requirements for Packaged Products:**
* The requirements are the same as for unpackaged products from non-listed third countries.
* Individual packaging must remain intact.
* If products were unloaded in a third country, a declaration is needed confirming that only unloading, storage, and reloading occurred, and products were handled at the required temperature.
Impact Analysis:
* **Competent Authorities in Member States:**
* *Impact:* Must implement and enforce the new requirements for re-entry of animal by-products and derived products. Responsible for issuing declarations, performing checks, and monitoring transport.
* *Action Required:* Update procedures to align with the amended regulations, train staff, and ensure compliance with monitoring requirements.
* **Operators (Businesses handling animal by-products):**
* *Impact:* Need to comply with the new documentation and handling requirements when re-importing refused consignments. Could face delays or rejection if requirements are not met.
* *Action Required:* Familiarize themselves with the new rules, ensure proper documentation (certificates, declarations), maintain seal integrity, and arrange for monitored transport from the border control post.
* **Border Control Posts:**
* *Impact:* Responsible for verifying documentation, performing checks, and authorizing entry of returning consignments.
* *Action Required:* Implement the new verification procedures, coordinate with competent authorities in Member States, and ensure compliance with monitoring requirements.
Key Entities Referenced
Regulation (EC) No 1069/2009: A European Parliament and Council regulation laying down health rules as regards animal byproducts and derived products not intended for human consumption.
Regulation (EU) No 142/2011: A Commission Regulation implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption.
Council Directive 97/78/EC: A Council Directive laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries.
Regulation (EU) 2017/625: A Regulation of the European Parliament and of the Council 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.
Commission Delegated Regulation (EU) 2019/2074: Commission Delegated Regulation supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards rules on specific official controls on consignments of certain animals and goods originating from, and returning to the Union following a refusal of entry by a third country
Commission Delegated Regulation (EU) 2019/1666: Commission Delegated Regulation supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards conditions for monitoring the transport and arrival of consignments of certain goods from the border control post of arrival to the establishment at the place of destination in the Union
European Union: A political and economic union of member states located primarily in Europe.
European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
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II
(Non-legislative acts)
REGULATIONS
COMMISSION REGULATION (EU) 2020/797
of 17 June 2020
amending Regulation (EU) No 142/2011 as regards requirements for animal by-products and derived
products originating from, and returning to, the Union following refusal of entry by a third country
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying
down health rules as regards animal by-products and derived products not intended for human consumption and repealing
Regulation (EC) No 1774/2002(1), and in particular the first subparagraph of Article 41(3) and Article 42(2)(a) thereof,
Whereas:
(1) Commission Regulation (EU) No 142/2011(2) lays down measures to implement the rules laid down in Regulation
(EC) No 1069/2009, including public and animal health rules for import or transit of animal by-products and
derived products into, or sent in transit through the Union, in order to prevent and minimise risks to public and
animal health arising from those products.
(2) Article 15 of Council Directive 97/78/EC(3) lays down rules concerning the veterinary checks to be conducted for
the purposes of authorising the re-importation of consignments of products of Union origin returning to the Union
following a refusal of entry by a third country. Regulation (EU) 2017/625 of the European Parliament and of the
Council(4) repeals and replaces Directive 97/78/EC with effect from 14 December 2019.
(1) OJ L 300, 14.11.2009, p. 1.
(2) Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European
Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human
consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at
the border under that Directive (OJ L 54, 26.2.2011, p. 1).
(3) Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on
products entering the Community from third countries (OJ L 24, 30.1.1998, p. 9).
(4) 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) (OJ L 95, 7.4.2017, p. 1).L 194/2 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union 18.6.2020
(3) Commission Delegated Regulation (EU) 2019/2074(5) establishes rules for the performance of specific official
controls of consignments of animals and goods referred to in Article 47(1)(a), (b) and (c) of Regulation (EU)
2017/625 originating from, and returning to, the Union following a refusal of entry by a third country, among
them animal by-products and derived products.
(4) The animal and public health requirements for the entry into the Union of animal by-products and derived products
originating from, and returning to, the Union following a refusal of entry by a third country should be established in
accordance with Articles 41 and 42 of Regulation (EC) No 1069/2009.
(5) In the absence of animal and public health requirements relevant for the return of refused consignments of animal
by-products and derived products, those consignments are subject to the general import rules set out in Regulation
(EC) No 1069/2009 and product-specific requirements for importation set out in Annex XIV to Regulation (EU)
No 142/2011, which could prevent the return to the Union of certain consignments of EU origin following refusal
by a third country, for example because of the absence of the product-specific commercial document or health
certificate required for entry.
(6) However, animal and public health risk posed by animal by-products and derived products originating from the
Union is different to risks posed by those commodities originating in third countries. A consignment of animal by-
products and derived products originating from, and returning to, the Union following a refusal of entry by third
countries therefore does not need to be accompanied by a commercial document, health certificate or where
appropriate declaration which corresponds to a model currently laid down pursuant to point (d) of the first
subparagraph of Article 42(2) of Regulation (EC) No 1069/2009 as required for consignments originating from
third countries.
(7) The aforementioned consignment should be allowed to enter the Union and to be sent to any establishment or plant
approved in accordance with Article 24 of Regulation (EC) No 1069/2009 for the Category and type of animal by-
products and derived products, provided that the competent authority of the place of destination in the Union has
agreed to accept that consignment.
(8) Certain consignments of animal by-products or derived products intended for export to third countries may be
subject to checks by a competent authority in the Union other than those responsible for animal by-products or
derived products. If the original seal has been replaced during those checks, the number of the new seal should be
indicated in the accompanying documentation.
(9) Therefore, to ensure appropriate animal and public health risk management and legal certainty, it is necessary to
provide for conditions for the return to the Union of animal by-products and derived products of Union origin
following a refusal of entry by a third country.
(10) To ensure traceability of the returning consignments of animal by-product and derived products, their transport
from the border control post of arrival in the Union to the establishment of destination should be monitored in
accordance with the procedure provided for in Commission Delegated Regulation (EU) 2019/1666(6).
(11) Annex XIV to Regulation (EU) No 142/2011 should be amended accordingly.
(12) As Delegated Regulation (EU) 2019/2074 applies from 14 December 2019, the rules laid down in this Regulation
should also apply from that date.
(13) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
(5) Commission Delegated Regulation (EU) 2019/2074 of 23 September 2019 supplementing Regulation (EU) 2017/625 of the European
Parliament and of the Council as regards rules on specific official controls on consignments of certain animals and goods originating
from, and returning to the Union following a refusal of entry by a third country (OJ L 316, 6.12.2019, p. 6).
(6) Commission Delegated Regulation (EU) 2019/1666 of 24 June 2019 supplementing Regulation (EU) 2017/625 of the European
Parliament and of the Council as regards conditions for monitoring the transport and arrival of consignments of certain goods from
the border control post of arrival to the establishment at the place of destination in the Union (OJ L 255, 4.10.2019, p. 1).18.6.2020 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 194/3
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EU) No 142/2011 is amended as follows:
(1) in Article 25(3), the following point is added:
‘(c) the specific requirements for animal by-products and derived products originating from, and returning to, the
Union following a refusal of entry by a third country, set out in Chapter VI of that Annex.’;
(2) in Article 26, the following point is added:
‘(e) the materials originating from a Member State and returning to that Member State following a refusal of entry by a
third country, must comply with the specific requirements set out in Chapter VI of Annex XIV.’;
(3) in Article 31, the following paragraph is added:
‘By way of derogation from the first paragraph, animal by-products and derived products originating from, and
returning to, the Union following a refusal of entry by a third country, must comply with the specific requirements set
out in Chapter VI of Annex XIV.’;
(4) Annex XIV is amended in accordance with the text in the Annex to this Regulation.
Article 2
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 June 2020.
For the Commission
The President
Ursula VON DER LEYENL 194/4 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union 18.6.2020
ANNEX
In Annex XIV to Regulation (EU) No 142/2011, the following Chapter VI is added:
‘CHAPTER VI
REQUIREMENTS FOR THE ENTRY OF CONSIGNMENTS OF ANIMAL BY-PRODUCTS AND DERIVED PRODUCTS
ORIGINATING FROM, AND RETURNING TO, THE UNION FOLLOWING REFUSAL OF ENTRY BY A THIRD COUNTRY
Section 1
Unpackaged or in bulk animal by-products and derived products, originating from, and returning to, the Union
following refusal of entry by a third country not listed as a whole or part of its territory in Annex XIV
1. The competent authority at the border control post shall only authorise the entry into the Union of consignments of
unpackaged or in bulk animal by-products or derived products originating from, and returning to, the Union following
a refusal of entry by a third country not listed as a whole or part of its territory in Annex XIV for the entry into the
Union of the type of product, where the following conditions are met:
(a) the consignment is accompanied by the official certificate or document, either in its original or as authenticated
copy, or by the electronic equivalent of such certificate or document generated by use of IMSOC(1), issued by the
competent authority of the Member State of export;
(b) the consignment is accompanied by a declaration from the competent authority in the Member State of destination
in which that authority agrees to receive the consignment and indicates the place of destination;
(c) the consignment complies with both of the following conditions:
(i) it has remained sealed with an intact original seal, if the application of a seal prior to leaving the Union was
mentioned in the original certificate referred to in point 1(a) or another official document issued by an
authority in the Union;
(ii) it is accompanied by an official declaration of the competent authority or other public authority of the third
country which refused the entry of the consignment indicating the reason for the refusal.
2. By way of derogation from point 1(a), in the case where the consignment was exported without accompanying official
certificate or document, the origin of the consignment shall be authenticated in another way based on documented
evidence presented by the operator responsible for the consignment.
3. The transport of consignments of products referred to in point 1 from the border control post to the place of
destination shall be monitored in accordance with Article 2 of Commission Delegated Regulation (EU) 2019/1666.
Section 2
Unpackaged or in bulk animal by-products and derived products originating from, and returning to, the Union
following refusal of entry by a third country listed as a whole or part of its territory in Annex XIV
1. The competent authority at the border control post shall only authorise the entry into the Union of consignments of
unpackaged or in bulk animal by-products or derived products originating from, and returning to, the Union following
a refusal of entry by a third country listed as a whole or part of its territory in Annex XIV for the entry into the Union of
the type of product, where the requirements set out in points 1(a), (b) and (c)(ii), 2 and 3 of Section 1 are met.
2. Where the products referred to in point 1 have been unloaded, stored, re-loaded or the original seal has been replaced in
or upon entry into the third country or part of its territory listed in Annex XIV, the consignment shall be accompanied
by an official declaration of the competent authority or other public authority of that third country or territory:
(a) indicating the place and date of unloading, storage and re-loading and the seal number put on the container after
reloading;
(1) Commission Implementing Regulation (EU) 2019/1715 of 30 September 2019 laying down rules for the functioning of the information
management system for official controls and its system components (“the IMSOC Regulation”) (OJ L 261, 14.10.2019, p. 37).18.6.2020 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 194/5
(b) confirming that:
(i) the seal on the vehicle or container of the consignment was only broken for the purpose of official controls;
(ii) the products were handled only to the extent necessary, and in particular
— at the appropriate temperature required for the relevant types of animal by-products or derived products;
and
— in a way that prevents cross contamination of the products during the controls;
(iii) the vehicle or container was immediately re-sealed after the official controls
(c) indicating the reasons for unloading and storage.
Section 3
Packaged animal by-products and derived products originating from, and returning to, the Union following a
refusal of entry by a third country
1. The competent authority at the border control post shall only authorise the entry into the Union of consignments of
packaged animal by-products or derived products originating from, and returning to, the Union following a refusal of
entry by a third country where the requirements set out in Section 1 are met and the individual packaging of the
products has remained intact as compared to its state before exportation.
2. Where the products referred to in point 1 have been unloaded in a third country, the consignment is accompanied by an
official declaration of the competent authority or other public authority of the third country attesting that the products:
(a) have not been subjected to any handling other than unloading, storage and re-loading;
(b) were handled at the required temperature for the relevant types of animal by-products or derived products.’