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Document 32022R0893
Commission Implementing Regulation (EU) 2022/893 of 7 June 2022 amending Annex VI to Regulation (EC) No 152/2009 as regards the methods of analysis for the detection of constituents of terrestrial invertebrates for the official control of feed (Text with EEA relevance)
Commission Implementing Regulation (EU) 2022/893 of 7 June 2022 amending Annex VI to Regulation (EC) No 152/2009 as regards the methods of analysis for the detection of constituents of terrestrial invertebrates for the official control of feed (Text with EEA relevance)
Commission Implementing Regulation (EU) 2022/893 of 7 June 2022 amending Annex VI to Regulation (EC) No 152/2009 as regards the methods of analysis for the detection of constituents of terrestrial invertebrates for the official control of feed (Text with EEA relevance)
C/2022/3530
OJ L 155, 8.6.2022, pp. 24–35
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
8.6.2022 |
EN |
Official Journal of the European Union |
L 155/24 |
COMMISSION IMPLEMENTING REGULATION (EU) 2022/893
of 7 June 2022
amending Annex VI to Regulation (EC) No 152/2009 as regards the methods of analysis for the detection of constituents of terrestrial invertebrates for the official control of feed
(Text with EEA relevance)
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) (1), and in particular Article 34(6), first subparagraph, point (a), thereof,
Whereas:
(1) |
Commission Regulation (EC) No 152/2009 (2) establishes testing methods used to support official controls to enforce the ban on the use of processed animal protein in feed for food producing animals. This includes methods of analysis for the determination of constituents of animal origin for the official control of feed, which are described in Annex VI to that Regulation and performed by light microscopy or polymerase chain reaction (PCR). |
(2) |
The use of processed animal protein derived from farmed insects has been authorised in the feed of aquaculture animals by Commission Regulation (EU) 2017/893 (3), and in the feed of porcine animals and poultry by Commission Regulation (EU) 2021/1372 (4), but is still prohibited under Regulation (EC) No 999/2001 of the European Parliament and of the Council (5) in certain feed, notably in the feed of ruminants. |
(3) |
The European Union reference laboratory for animal proteins in feedingstuffs has developed and validated a special protocol, including a double sedimentation step, which ensures the detection of particles from terrestrial invertebrates, including insects, if present in feed materials, compound feed and premixtures submitted to laboratory testing. With this additional step, that protocol should be used in the framework of official controls to verify the correct enforcement of the ban on the use of processed animal protein of insects in certain feed for food producing animals. |
(4) |
The description of the light microscopy method set out in Annex VI to Regulation (EC) No 152/2009 should therefore be adjusted in order to include a double sedimentation step in the protocol for the preparation of samples to be tested for detecting constituents of terrestrial invertebrates. |
(5) |
Annex VI to Regulation (EC) No 152/2009 should therefore be amended accordingly. |
(6) |
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
Annex VI to Regulation (EC) No 152/2009 is 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, 7 June 2022.
For the Commission
The President
Ursula VON DER LEYEN
(2) Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).
(3) Commission Regulation (EU) 2017/893 of 24 May 2017 amending Annexes I and IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council and Annexes X, XIV and XV to Commission Regulation (EU) No 142/2011 as regards the provisions on processed animal protein (OJ L 138, 25.5.2017, p. 92).
(4) Commission Regulation (EU) 2021/1372 of 17 August 2021 amending Annex IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the prohibition to feed non-ruminant farmed animals, other than fur animals, with protein derived from animals (OJ L 295, 18.8.2021, p. 1).
(5) Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1).
ANNEX
Annex VI to Regulation (EC) No 152/2009 is amended as follows:
(1) |
point 1 is replaced by the following: ‘1. PURPOSE AND SCOPE The determination of constituents of animal origin in feed shall be performed by light microscopy or polymerase chain reaction (PCR) in accordance with the provisions laid down in this Annex. These two methods make it possible to detect the presence of constituents of animal origin in premixtures, feed materials and compound feed. However, they do not make it possible to calculate the amount of such constituents in premixtures, feed materials and compound feed. Both methods have a limit of detection below 0,1 % (w/w). The PCR method makes it possible to identify the taxonomic group of constituents of animal origin present in premixtures, feed materials and compound feed. These methods shall apply for the control of the application of the prohibitions laid down in Article 7(1) of Regulation (EC) No 999/2001 of the European Parliament and of the Council (*), Annex IV to that Regulation and Article 11(1) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council (**). Depending on the type of feed being tested, these methods may be used, within one single operational protocol, either on their own or combined together in accordance with the standard operating procedures (“SOPs”) established by the EU reference laboratory for animal proteins in feedingstuffs (EURL-AP) and published on its website (***). (*) Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1)." (**) 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 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1)." (***) https://www.eurl.craw.eu/legal-sources-and-sops/method-of-reference-and-sops/’;" |
(2) |
point 2.1 is replaced by the following: ‘2.1. Light microscopy 2.1.1. Principle The constituents of animal origin which may be present in premixtures, feed materials and compound feed sent for analysis are identified on the basis of typical and microscopically identifiable characteristics such as muscle fibres and other meat particles, cartilage, bones, horn, hair, bristles, invertebrates cuticular fragments, insect tracheal structures, blood products, milk globules, lactose crystals, feathers, egg shells, fish bones and scales. Microscopic examinations shall be performed after preparation of samples by sedimentation. Samples shall be subject to a sedimentation step as follows:
2.1.2. Reagents and equipment 2.1.2.1. Reagents 2.1.2.1.1. Concentrating agent
2.1.2.1.2. Staining reagent
2.1.2.1.3. Mounting media
2.1.2.1.4. Mounting media with staining properties
2.1.2.1.5. Rinsing agents
2.1.2.1.6. Bleaching reagent
2.1.2.2. Equipment
2.1.3. Sampling and sample preparation 2.1.3.1. Sampling A representative sample, taken in accordance with Annex I shall be used. 2.1.3.1.1. Sample drying Samples with a moisture content > 14 % shall be dried prior to handling in accordance with Annex III. 2.1.3.1.2. Sample pre-sieving In order to collect information on possible environmental contamination of the feed, it is recommended to pre-sieve at 1 mm pelleted feeds and kernels and to subsequently prepare, analyse, and report separately on the two resulting fractions, which must be considered as distinct samples. 2.1.3.2. Precautions to be taken In order to avoid laboratory cross-contamination, all reusable equipment shall be carefully cleaned before use. Separation funnel pieces shall be disassembled before cleaning. Separation funnel pieces and glassware shall be pre-washed manually and then washed in a washing machine. Sieves shall be cleaned by using a brush with stiff synthetic hairs. A final cleaning of sieves with acetone and compressed air is recommended after sieving of fatty material like fishmeal. 2.1.3.3. Preparation of samples consisting of fat or oil The following protocol shall be followed for the preparation of samples consisting of fat:
The same protocol, with the exception of the first and fourth indents, shall be applied for the preparation of samples consisting of oil. 2.1.3.4. Preparation of samples other than fat or oil
2.1.4. Microscopic examination 2.1.4.1. Slide preparation Microscopic slides shall be prepared from the sediment and, depending on operator’s choice, from either the flotate or the raw material. When appropriate, for the detection of terrestrial invertebrate constituents only, slides shall also be prepared from the final flotate obtained as described in point 2.1.3.4.4. The two resulting fractions (the fine and the coarse one) shall be prepared. Test portions of fractions spread on slides shall be representative of the whole fraction. A sufficient number of slides shall be prepared in order to ensure that a complete examination protocol as laid down in point 2.1.4.2 can be carried-out. Microscopic slides shall be mounted with the adequate mounting medium in accordance with the SOP established by the EURL-AP and published on its website. The slides shall be covered with coverslips. 2.1.4.2. Observation flowchart for the detection of animal particles in compound feed, feed material and premixtures. The prepared microscopic slides shall be observed in accordance with the observation flowcharts in Diagrams 1 and 2. The microscopic observations shall be conducted using the compound microscope on the sediment and, depending on the operator’s choice, either on the flotate or on the raw material. Additionally, for the detection of terrestrial invertebrate constituents, observations shall also be conducted on the final flotate obtained as described in point 2.1.3.4.4 in accordance with Diagram 3. The stereomicroscope may be used in addition to the compound microscope for the coarse fractions. Each slide shall be screened entirely at various magnifications. Precise explanations on how to use the flowcharts are detailed by a SOP established by the EURL-AP and published on its website. The minimum numbers of slides to be observed at each step of the observation flowcharts shall be strictly respected unless the entire fraction material does not permit to reach the stipulated slide number, for instance when no sediment is obtained. No more than 6 slides per determination shall be used for recording of the number of particles. When additional slides are prepared using a more specific mounting medium with staining properties, as described in point 2.1.2.1.4, on the flotate or the raw material to further characterise structures (e.g. feathers, hairs, muscle or blood particles), which have been detected on slides prepared by other mounting media, as described in point 2.1.2.1.3, the number of particles shall be counted based on a number of slides per determination not exceeding 6, including the additional slides with a more specific mounting medium. The additional slides prepared from the final flotate obtained, as described in point 2.1.3.4.4, for the detection of terrestrial invertebrate constituents shall not be considered for the identification of other natures (terrestrial vertebrates and fish). In order to facilitate the identification of the particles’ nature and origin, the operator may use support tools like decision support systems, image libraries and reference samples. Diagram 1 Observation flowchart after single TCE sedimentation for the detection of animal particles other than from terrestrial invertebrates in compound feed, feed materials and premixtures for the first determination
Diagram 2 Observation flowchart after single TCE sedimentation for the detection of animal particles other than from terrestrial invertebrates in compound feed, feed materials and premixtures for the second determination
Diagram 3 Observation flowchart after double PE/TCE sedimentation for the detection of terrestrial invertebrates’ constituents in compound feed, feed materials and premixtures
2.1.4.3. Number of determinations Determinations shall be performed on different sub-samples of 50 g each. If, following the first determination carried out in accordance with the observation flowchart in Diagram 1, or Diagram 3 when appropriate, no animal particles are detected, no additional determination shall be necessary and the result of the analysis shall be reported using the wording set out in point 2.1.5.1. If, following the first determination carried out in accordance with the observation flowchart in Diagram 1, one or more animal particles of a given nature (i.e. terrestrial vertebrates or fish) are detected and the nature of the particles found confirms the declared content of the sample, no second determination shall be necessary. If the number of the animal particles of a given nature detected during this first determination is higher than 5, the result of the analysis shall be reported per animal nature using the wording set out in point 2.1.5.3. Otherwise, the result of the analysis shall be reported per animal nature using the wording set out in point 2.1.5.2. If, following the first determination carried out in accordance with the observation flowchart in Diagram 3, more than 5 particles of terrestrial invertebrates are detected, no second determination shall be necessary and the result of the analysis shall be reported using the wording set out in point 2.1.5.3 for this nature. In all other cases, including when no declaration of content has been provided to the laboratory, a second determination shall be carried out from a new sub-sample. If, following the second determination carried out in accordance with the observation flowchart in Diagram 2, or Diagram 3 when appropriate, the sum of the animal particles of a given nature detected over the two determinations is higher than 10, the result of the analysis shall be reported per animal nature using the wording set out in point 2.1.5.3. Otherwise, the result of the analysis shall be reported per animal nature using the wording set out in point 2.1.5.2. 2.1.5. Expression of the results When reporting the results, the laboratory shall indicate on which type of material the analysis has been carried out (sediment, flotate, final flotate or raw material). The reporting shall clearly indicate how many determinations have been carried out and if sieving of the fractions prior to slide preparation, in accordance with point 2.1.3.4.3, first indent, third paragraph, or point 2.1.3.4.4, third indent, was not performed. The laboratory report shall at least contain information on the presence of constituents derived from terrestrial vertebrates and from fish. The different situations shall be reported in the following ways.
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(*) Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1).
(**) 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 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1).
(***) https://www.eurl.craw.eu/legal-sources-and-sops/method-of-reference-and-sops/’;”