Commission Implementing Regulation (EU) 2019/1084 of 25 June 2019 amending Regulation (EU) No 142/2011 as regards the harmonisation of the list of approved or registered establishments, plants and operators and the traceability of certain animal by-products and derived products (Text with EEA relevance.)
Date: 2019-06-25
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: Bosnia and Herzegovina, Russia, animal product, by-product, health certificate, health control, health risk, import (EU), traceability, veterinary inspection




L_2019171EN.01010001.xml










26.6.2019   


EN


Official Journal of the European Union


L 171/100








            COMMISSION IMPLEMENTING REGULATION (EU) 2019/1084
of 25 June 2019
         
amending Regulation (EU) No 142/2011 as regards the harmonisation of the list of approved or registered establishments, plants and operators and the traceability of certain animal by-products and derived products
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

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 Articles 21(5)(a), 23(3), 41(4), 47(2) and 48(2) thereof,

Whereas:







(1)


Commission Regulation (EU) No 142/2011 (2) lays down implementing rules for Regulation (EC) No 1069/2009, including requirements concerning commercial documents and traceability of animal by-products and derived products.












(2)


Pursuant to Article 21 of Regulation (EC) No 1069/2009, each consignment of animal by-products and derived products is to be accompanied during transportation by a commercial document drawn up in accordance with the model set out in Annex VIII to Regulation (EU) No 142/2011 and completed by the operator.












(3)


The competent authority of the Member State of origin is to notify the dispatch of animal by-products and derived products subject to Article 48(3) of Regulation (EC) No 1069/2009 to the competent authority of the Member State of destination by means of the integrated computerised veterinary system (TRACES) introduced by Commission Decision 2004/292/EC (3).












(4)


For the purpose of efficient official controls at the place of destination, operators involved in the dispatch of consignments subject to Article 48(3) of Regulation (EC) No 1069/2009 should only be allowed to choose the place of destination from lists of approved or registered establishments and plants integrated in TRACES, and not from lists of registered operators also integrated in TRACES.












(5)


Regulation (EU) No 142/2011 should therefore be amended to include requirements for the harmonised lists of approved or registered establishments and plants and provide that harmonised and up-to-date lists are entered in or accessible by TRACES. A new Article should therefore be added to Chapter VI of Regulation (EU) No142/2011.












(6)


Harmonisation of lists in or accessibility by TRACES may present an administrative burden for competent authorities in Member States. Competent authorities should therefore have an appropriate transitional period for the implementation of the new provisions.












(7)


Article 30 of Regulation (EU) No 142/2011 should not apply in case of specific movements of animal by-products and derived products between territories of the Russian Federation referred to in Article 29 of that Regulation and in case of specific transit through Croatia of animal by-products and derived products coming from Bosnia and Herzegovina and destined to third countries referred to in Article 29a of that Regulation. The specific requirements for the movements and transits laid down in the aforementioned Articles provide for an appropriate level of protection of public and animal health and thus allow for a derogation from the listing of establishments and plants of origin in TRACES.












(8)


Article 30 of Regulation (EU) No142/2011 should therefore be amended accordingly.












(9)


Pursuant to Article 21(2) of Regulation (EC) No 1069/2009, operators are to ensure that animal by-products and derived products are accompanied during transport by a commercial document. In order to prevent the use of certain animal by-products and derived products in the production chain of feed for farmed animals, the activities of registered traders responsible for arranging transport should be clarified and made more transparent for the purpose of official controls. The model of the commercial document that is to accompany the aforementioned animal by-products and derived products should be adapted in order to provide for the necessary information.












(10)


Certain animal by-products and derived products laid down in Article 48(3) of Regulation (EC) No1069/2009 are subject to channelling procedures. Operators and competent authorities should ensure that, where storage is required, such animal by-products or derived products always arrive to a storage plant registered in accordance with Article 23(1)(a) of Regulation (EC) No1069/2009, an establishment or plant approved in accordance with Article 24(1) of that Regulation or arrive at the destination set out in Article 24(1)(j)(i) to (iv) thereof. It is therefore necessary to adapt the model of commercial document to the requirements laid down in Article 48(3) of Regulation (EC) No1069/2009.












(11)


The duration of transport between the place of origin and the place of destination should be limited to 15 working days to ensure the traceability of consignments. Should a consignment not arrive at the place of destination within this period, all involved competent authorities are to identify the location of such consignment immediately.












(12)


Several new commodities are subject to trade between Member States. The Commercial document should be revised to list those new commodities accordingly.












(13)


Annex VIII to Regulation (EU) No 142/2011 should therefore be amended accordingly.












(14)


The dispatch to other Member States of animal by-products and derived products referred to in Article 48(1) of Regulation (EC) No 1069/2009 shall be authorised in advance by the competent authority of the Member State of destination upon application by the operator. Annex XVI to Regulation (EU) No 142/2011 sets out a standard format for the authorisation of the dispatch of animal by-products and derived products to another Member State. That format should be amended to include information on the authorised destination of derived products and the authorised users of animal by-products or derived products. Authorisation of those animal by-products and derived products in one Member State does not preclude a refusal of such dispatch by the competent authorities in other Member States. The standard format for the authorisation should be introduced in TRACES and electronically linked to the commercial document used for the authorised consignment s of animal by-products or derived products in order to prevent generation of the commercial document without a completed application form approved by the competent authority at the place of destination.












(15)


Annex XVI to Regulation (EU) No 142/2011 should be amended accordingly.












(16)


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 1
Regulation (EU) No 142/2011 is amended as follows:






(1)


the following Article 20a is inserted:

‘Article 20a
Lists of establishments, plants and operators in Member States
The competent authority of a Member State shall ensure that up-to-date lists of establishments, plants and operators, referred to in the first subparagraph of Article 47(1) of Regulation (EC) No 1069/2009 are:






(a)


drawn up in accordance with the technical specifications published on the Commission website (*1);










(b)


either entered in TRACES or accessible by means of TRACES as of 31 October 2021 at the latest.






(*1)  https://ec.europa.eu/food/sites/food/files/safety/docs/fs-animal-products-app-est-technical_spec_04032012_en.pdf’
                                                "
                        










(2)


in Article 30, the following paragraph is added:
‘This Article does not apply to the specific movements of consignments of animal by-products coming from and destined to the Russian Federation as referred to in Article 29 and to the movements of consignments of animal by-products and derived products coming from Bosnia and Herzegovina and destined to third countries as referred to in Article 29a.’;










(3)


in Article 32, paragraph 7 is replaced by the following:

‘7.   Operators shall submit applications for the authorisation referred to in paragraph 6 in accordance with the standard format set out in Section 10 of Chapter III of Annex XVI hereto by means of TRACES.’;











(4)


Annexes VIII and XVI are amended in accordance with 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.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 June 2019.


For the Commission


The President

Jean-Claude JUNCKER
            





(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)  Commission Decision 2004/292/EC of 30 March 2004 on the introduction of the Traces system and amending Decision 92/486/EEC (OJ L 94, 31.3.2004, p. 63).




ANNEX
Regulation (EU) No 142/2011 is amended as follows:






(1)


in Annex VIII, Chapter III, point 6 is amended as follows






(a)


in point (f), points (iv) to (vii) are replaced by the following:






‘(iv)


the name and address of the establishment or plant of origin of the material and its approval or registration number assigned in accordance with Regulation (EC) No 1069/2009 or, where applicable, in accordance with Regulations (EC) No 852/2004 (1), (EC) No 853/2004 (2) or (EC) No 183/2005 of the European Parliament and of the Council (3), and the nature and the method of the treatment, as applicable;










(v)


the name, the address and the registration number of the transporter of the material;










(vi)


the name and address of the establishment or plant of destination and the registration or approval number assigned in accordance with Regulation (EC) No 1069/2009 or, where applicable, in accordance with Regulations (EC) No 852/2004 or (EC) No 183/2005;










(vii)


in case of transport in containers, the complete container identification number (“BIC code”) issued in accordance with the requirements of the Bureau International des Containers et du Transport Intermodal (4);










(viii)


in case of export of processed animal protein and products containing processed animal proteins as referred to in Annex IV to Regulation (EC) No 999/2001, the Member State of exit and border inspection post referred to in Commission Decision 2009/821/EC (5) of exit.’














(b)


the following point (i) is added:






‘(i)


The competent authority responsible for the place of destination referred to in the second subparagraph of Article 48(3) of Regulation (EC) No 1069/2009 shall, within 15 working days of the receipt of the information referred to in the first subparagraph of Article 48(3) of that Regulation, inform the competent authority of the Member State of origin of the arrival of the consignment by means of TRACES.’














(c)


the model of commercial document is replaced by the following:

                                             ‘
                                             Commercial document


For the transport within the European Union of animal by-products and derived products not intended for human consumption in accordance with Regulation (EC) No 1069/2009




Text of image

EUROPEAN UNION
Commercial document
Part I: Details of dispatched consignment
I.1. Consignor
Name
Address
Approval or registration number
Postcode
I.2. Document reference No
I.2.a Local reference No
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Approval or registration number
Tel.
I.6. Registered trader
Name
Registration number
Address
Postcode
Member State
I.7
I.8. Country of origin
ISO code
I.9. Region of origin
Code
I.10. Country of destination
ISO code
I.11. Region of destination
Code
I.12 Place of origin
Establishment
Name Approval or registration number
Address
Postcode
I.13. Place of destination
Establishment
Name Approval or registration number
Address
Postcode
I.14. Place of loading
I.15. Date of departure
I.16. Means of transport
Aeroplane
Road vehicle
Identification:
Ship
Other
Railway wagon
I.17. Transporter
Name
Address
Postcode
Approval or Registration number
Member State
I.18. Description of commodity
I.19. Commodity code (CN code)
I.20. Total Quantity




Text of image

I.21. Temperature of products
I.22. Number of packages
Ambient
Chilled
Frozen
Controlled temperature
I.23. Seal number if a seal imposed by competent authority and the Container BIC ID number
I.24. Type of packaging
I.25. Commodities certified for:
Animal feedingstuff
Technical use
petfood use
Organic fertilisers/soil improvers
Consignment is subject to requirements laid down in Regulation (EC) No 999/2001.
Category 3 fish oil/fishmeal with excessive level(s) of dioxins and/or PCBs intended for detoxification according to Regulation (EU) 2015/786.
I.26.
I.27. Transit through Member States
Member State ISO code
Member State ISO code
Member State ISO code
I.28. Export
Third country ISO code
Exit point Code
I.29.
I.30.
I.31. Identification of the commodities
Approval number of establishments
Species
Nature of commodity
Category
Treatment type
Manufacturing plant
Batch number




Text of image

COUNTRY
Animal by-products/derived products not intended for human consumption
II. Health information
II.a. Certificate reference No
II.b.
Part II: Declaration
II.1 Declaration by the consignor
I, the undersigned, declare that:
II.1.1. the information in Part I is factually correct;
II.1.2. all precautions have been taken to avoid contamination of the animal by-products or derived products with pathogenic agents and cross-contamination between various categories.
Notes
Part I:
— Box reference I.1: The legal or physical person ordering the transport indicated in the document required by the Convention relative au Contract de Transport International de Marchandises par Route (CMR).
— Box reference I.5: The legal or physical person for which the consignment is destined.
— Box reference I.6[optional, if appropriate]: Registered trader name, address, registration number.
— Box reference I.9 and I.11: if appropriate.
— Box reference I.12, I.13: approval number or registration number.
In case of:
— products subject to Article 48(3) of Regulation (EC) No 1069/2009 only a storage plant, incineration or co-incineration plant registered in accordance with Article 23(1)(a); an establishment or plant approved in accordance with Article 24 of Regulation (EC) No 1069/2009 or in case of manure the authorised farm of destination;
— fish oil or fishmeal of Category 3 intended for detoxification according to Regulation (EU) 2015/786 indicate the approval number of the plant of destination according to Regulation (EC) No 183/2005 or Regulation (EU) 2015/786.
— Box reference I.14: complete if different from I.1. and I.12.
— Box reference I.17: registration or approval number of the actual transporter. If this is the same information as in Box I.6, use only box I.17.
— Box reference I.23: in case of transport in container, the complete container identification number (“BIC code”) is obligatory.
— Box reference I.25: technical use: any use other than for animal consumption or organic fertilisers or soil improvers OF/SI. Technical products cannot be used in feed,petfood or OF/SI.
— Box reference I.31:
Animal species: For Category 3 material and products derived therefrom destined for use as feed material. Select from the following: Aves, Ruminants, Suidae, other Mammalia, Pesca, Mollusca, Crustacea, Insecta (species, if appropriate), other Invertebrates, Mixed non-ruminant species, Mixed species containing ruminants.
Nature of commodity: Enter a commodity chosen from the following list: “apiculture by-products”, “blood products”, “blood”, “bloodmeal”, “digestion residues”, “digestive tract content”, “dog-chews”, “fishmeal”, “flavouring innards”, “gelatine”, “greaves”, “hides and skins”, “hydrolysed proteins”, “organic fertilisers/soil improvers”, “pet food”, “processed animal protein”, “animal by-products for the production of pet food”, “raw pet food”, “rendered fats”, “compost”, “processed manure”, “fish oil”, “milk products”, “colostrum products” “centrifuge or separator sludge from milk processing”, “dicalciumphosphate”, “tricalciumphosphate”, “collagen”, “egg products”, “serum of equidae”, “game trophies”, “wool”, “hair”, “pig bristles”, “feathers”, “animal by-products for processing”, “derived products”, “meat-and-bone meal”, “cadavers”, “manure”, “fat derivatives”, “glycerine”, “former food stuffs”, “catering waste”, “used cooking oil”, “treated hides and skins”, “growing media”, “dead pet animals”, “dead equidae”, “former feed stuffs”, “[nature of ABP or DP] mixed with non hazardous waste [EURAL code]”, “eggs”, “hatchery by products”, “embryos in eggs or not”.




Text of image

COUNTRY
Animal by-products/derived products not intended for human consumption
II. Health information
II.a. Certificate reference No
II.b.
Category: Specify Categories 1, 2 or 3 materials.
In case of Category 3 material intended for use as feedstuff, indicate the point of Article 10 of Regulation (EC) No 1069/2009 that refers to the animal by-product concerned (e.g. Article 10(a), Article 10(b) etc).
In the case of Category 3 material for use in raw petfood indicate “3a”, “3b(i)” or “3b(ii)” depending on whether the animal by-products are referred to in Article 10(a) or in Article 10(b)(i) or (ii) of Regulation (EC) No 1069/2009.
In the case of hides and skins and products derived therefrom, indicate “3b(iii)” or “3(n)” depending on whether the animal by-products or derived products are referred to in Article 10(b)(iii) or in Article 10(n) of Regulation (EC) No 1069/2009.
Treatment type: For treated hides and skins indicate the treatment:
“(a)” for dried;
“(b)” for dry-salted or wet-salted for at least 14 days prior to dispatch;
“(c)” for salted for seven days in sea salt with the addition of 2 % sodium carbonate.
For Category 1 and 2 materials, describe the method of processing or transformation. Indicate the relevant processing method (choose a method from 1 to 5 referred to in Chapter III or an alternative method referred to Chapter IV of Annex IV to Regulation (EU) No 142/2011) or processing method for processed manure referred to in Annex XI thereof and indicate date of GTH marking as applicable.
For Category 3 materials destined for use in feed refer to the appropriate Section of Annex X to Regulation (EU) No 142/2011.
For derived products from Category 3 material destined for use in feed, indicate the relevant standard processing method (choose a method from 1 to 7 referred to in Chapter III of Annex IV to Regulation (EU) No 142/2011 in case of processed animal protein (PAP)), an alternative method referred to Chapter IV of Annex IV in case of ensilage, or describe the nature and the methods of treatment set out in Chapter II of Annex X to Regulation (EU) No 142/2011.
Fish oil or fishmeal for detoxification shall be labelled as “fish oil or fishmeal with excessive level(s) of dioxins and/or PCBs in accordance with Annex I to Directive 2002/32/EC destined for detoxification in an approved establishment”
Batch number: Enter batch number or ear tag number, if applicable.
Manufacturing plant: in the case of PAP and other feed materials indicate the processing plant
Part II:
— The signature must be in a different colour to that of the printing.
Signature
Done at on
(place) (date)
(signature of the responsible person of place of origin)
(name, in capital letters)

                                       ’
                                    













(2)


in Annex XVI, Chapter III, Section 10 is replaced by the following:

                                 ‘
                                 Section 10


Standard format for applications for certain authorisations in intra-Union trade

Operators shall inform the competent authority of the Member State of origin and apply to the competent authority of the Member State of destination for the authorisation of the dispatch of animal by-products and derived products referred to in Article 48(1) of Regulation (EC) No 1069/2009, and fish oil or fishmeal of Category 3 materials intended for detoxification in accordance with the following format in TRACES:



Text of image

Reference number:
PAGE 1/2
APPLICATION FOR THE AUTHORISATION OF THE DISPATCH OF ANIMAL BY-PRODUCTS AND DERIVED PRODUCTS TO ANOTHER MEMBER STATE(ARTICLE 48 OF REGULATION (EC) No 1069/2009)
Name and address of applicant
Approval or registration number (2)
Name and address of place(s) of origin
Approval or registration number(s) (2)
Name and address of consignor (1)
Approval or registration number (2)
Name and address of place(s) of destination(s) (3)
Approval or registration number(s) (3)
Animal by-products/derived products (4)
Category 1 material consisting of:
(nature of the material)
Category 2 material consisting of:
(nature of the material)
Meat-and-bone meal derived from Category 1 material
Rendered fats derived from Category 1 material
Meat-and-bone meal derived from Category 2 material
Rendered fats derived from Category 2 material
Fish oil or fishmeal with excessive level(s) of dioxins and/or PCBs in accordance with Annex I to Directive 2002/32/EC destined for detoxification in an approved establishment
Intended use (4)
Disposal as a waste
Processing
Combustion
Incineration or co-incineration in ABP approved establishments or plants
Application to land
Transformation into biogas
Composting
Establishment for intermediate activities
Petfood (5)
Production of biodiesel or other biofuels
For feeding to (6):
For the manufacture of the following derived products (7) (2):
Destined for detoxification in an approved establishment (2)
Indicate the quantity of animal by-products/derived products (volume or mass) (2) (8):




Text of image

Reference number:
PAGE 2/2
APPLICATION FOR THE AUTHORISATION OF THE DISPATCH OF ANIMAL BY-PRODUCTS AND DERIVED PRODUCTS TO ANOTHER MEMBER STATE(ARTICLE 48 OF REGULATION (EC) No 1069/2009)
In case of meat-and-bone meal and rendered fats:
The materials have been processed according to the following method (9):
The materials have been marked with GTH.
Species of origin (information should correspond to the indication of species in DOCOM/CD (12)):
In the case of fish oil intended for detoxification, processing method:
I, the undersigned, declare that the above information is factually correct.
(Signature: name, date, contact details: telephone, fax (if applicable), e-mail)
Decision by the competent authority of the Member State of destination (10):
The dispatch of the consignment is:
refused.
accepted.
accepted subject to the application of pressure sterilisation (method 1) to the materials and GTH marking.
accepted subject to the following conditions for the dispatch (2):
This authorisation is valid until (11)
(Date, stamp and signature of the competent authority)
Notes:
Complete the document in BLOCK capitals.
(1) Fill in, if consignor is different from applicant.
(2) Fill in, if appropriate.
(3) In case of consignments in bulk multiple places of destination, the applicant is responsible for providing the LVU with all the details of the various places of destination The size of the box may be extended to include all required data. The number of multiple places of destination is subject to decision of the competent authority, responsible for the place(s) of destination.
(4) Tick as appropriate.
(5) In the case of petfood produced with Category 1 material, imported from third countries, referred to in Article 8(c) of Regulation (EC) No 1069/2009.
(6) Specify in accordance with Article 18 of Regulation (EC) No 1069/2009.
(7) Specify intended uses, such as for the manufacture of fur, organic fertilisers/soil improvers, taxidermy, etc.
(8) Specify. In case of dead equidae indicate the number of the transponder (microchip), if available, or the unique life number as defined in Article 2(o) of Commission Regulation (EU) 2015/262 as indicated in the identification document.
(9) Specify one of the processing methods referred to in Chapter III or Chapter IV of Annex IV to Regulation (EU) No 142/2011.
(10) For the competent authority: tick as appropriate.
(11) Insert date of expiration of authorisation.
(12) DOCOM: commercial document in TRACES form/CD: commercial document.

                           ’
                        





(1)  Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).

(2)  Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55).

(3)  Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1).

(4)  https://www.bic-code.org/identification-number/

(5)  Commission Decision 2009/821/EC of 28 September 2009 drawing up a list of approved border inspection posts, laying down certain rules on the inspections carried out by Commission veterinary experts and laying down the veterinary units in Traces (OJ L 296, 12.11.2009, p. 1).