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
(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 (Animal by-products Regulation) , and in particular Articles 5(2) and 6(1)(b)(ii) and the second subparagraph of Article 6(1), the second subparagraph of Article 6(2), Article 11(2)(b) and (c) and the second subparagraph of Article 11(2), Article 15(1)(b), (d), (e), (h) and (i) and the second subparagraph of Article 15(1), Articles 17(2) and 18(3), Article 19(4)(a), (b) and (c) and the second subparagraph of Article 19(4), Article 20(10) and (11), Article 21(5) and (6), Articles 22(3) and 23(3), Article 27(a), (b), (c) and (e) to (h) and the second subparagraph of Article 27, Articles 31(2), 32(3), Article 40, the first and third subparagraph of Article 41(3), Article 42, Articles 43(3), 45(4), 47(2), Article 48(2), Article 48(7)(a) and (8)(a) and the second subparagraph of Article 48(8) thereof,
Having regard to 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 , and in particular Article 16(3) thereof,
Whereas:
(1)
Regulation (EC) No 1069/2009 lays down animal and public health rules for animal by-products and products derived thereof. That Regulation determines the circumstances under which animal by-products are to be disposed of, in order to prevent the spreading of risks for public and animal health. In addition, that Regulation specifies under which conditions animal by-products may be used for applications in animal feed and for various purposes, such as in cosmetics, medicinal products and technical applications. It also lays down obligations for operators to handle animal by-products within establishments and plants which are subject to official controls.
(2)
Regulation (EC) No 1069/2009 provides that detailed rules for the handling of animal by-products and derived products, such as processing standards, hygiene conditions and the format for documentary evidence which has to accompany consignments of animal by-products and derived products for the purposes of traceability are to be adopted by means of implementing measures.
(3)
The detailed rules for the use and disposal of animal by-products in this Regulation should be laid down with a view to the achievement of the objectives of Regulation (EC) No 1069/2009, notably the sustainable use of animal materials, and a high level of protection of public and animal health in the European Union.
(4)
Regulation (EC) No 1069/2009 does not apply to entire bodies or parts of wild animals, which are not suspected of being infected or affected with a disease communicable to humans or animals, except for aquatic animals landed for commercial purposes. In addition, it does not apply to entire bodies or parts of wild game which are not collected after killing, in accordance with good hunting practice. Regarding those animal by-products from hunting, disposal should be carried out in a way which prevents the transmission of risks, as appropriate for specific hunting practices and in accordance with the good practice as it has been described by the hunting profession.
(5)
Regulation (EC) No 1069/2009 applies to animal by-products for the preparation of game trophies. The preparation of such trophies, as well as the preparations of animals and parts of animals for which other methods, such as plastination, are used, should take place under conditions which prevent the transmission of risks for human or animal health.
(6)
Regulation (EC) No 1069/2009 applies to catering waste if it originates from means of transport operating internationally, such as materials derived from foodstuffs served on board an airplane or a ship arriving in the European Union from a third country destination. Catering waste also falls within the scope of that Regulation, if it is destined for feeding purposes, for processing in accordance with one of the authorised processing methods under this Regulation or for transformation into biogas or for composting. Regulation (EC) No 1069/2009 prohibits the feeding of catering waste to farmed animals, other than fur animals. Therefore, in accordance with Regulation (EC) No 1069/2009, catering waste may be processed and subsequently used, provided that the derived product is not fed to such animals.
(7)
For the sake of consistency of Union legislation, the definition of feed materials in Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EEC and 96/25/EC and Commission Decision 2004/217/EC should be used as a basis for defining feed materials of animal origin in this Regulation.
(8)
Regulation (EC) No 1069/2009 prohibits the dispatch of animal by-products and of derived products from susceptible species from holdings, establishments, plants or zones which are subject to restrictions due to the presence of a serious transmissible disease. In order to provide for a high level of protection of animal health in the Union, the list of diseases in the Terrestrial and Aquatic Animal Health Codes of the World Organisation of Animal Health (hereinafter referred to as ‘OIE’) should be specified as the list of serious transmissible diseases for the purpose of determining the scope of this prohibition.
(9)
Since the incineration and the co-incineration of certain animal by-products do not fall within the scope of Directive 2000/76/EC of the European Parliament and of the Council of 4 December 2000 on the incineration of waste , adequate rules for the prevention of health risks arising from such operations should be laid down in this Regulation, taking into account the possible effects on the environment. Residues from the operation of the incineration or co-incineration of animal by-products or derived products should be recycled or disposed of, in accordance with Union environmental legislation, since in particular, that legislation allows for the use of the phosphorous component of ashes in fertilisers and for the handover of ashes from the cremation of pet animals to the owners.
(10)
Products of animal origin or foodstuffs containing such products, should only be disposed of in a landfill, in accordance with Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste , if they have been processed as defined in Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs , in order to mitigate potential health risks.
(11)
The disposal of animal by-products or derived products via the wastewater stream should be prohibited, since that stream is not subject to requirements which would ensure an appropriate control of public and animal health risks. Appropriate measures should be taken to prevent unacceptable risks from accidental disposal of liquid animal by-products, such as from the cleaning of floors and equipments used for processing.
(12)
Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives lays down certain measures to protect the environment and human health. Article 2(2)(b) of that Directive provides that certain matters are excluded from the scope of that Directive to the extent that they are covered by other Union legislation, including animal by-products covered by Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption , except those which are destined for incineration, landfilling or use in a biogas or composting plant. That Regulation has now been repealed and replaced by Regulation (EC) No 1069/2009 from 4 March 2011. In the interests of coherency of Union legislation, the processes whereby animal by-products and derived products are transformed into biogas and composted should comply with the health rules laid down in this Regulation, as well as the measures for the protection of the environment laid down in Directive 2008/98/EC.
(13)
The competent authority of a Member State should be able to authorise alternative parameters for the transformation of animal by-products into biogas or for their composting on the basis of a validation according to a harmonised model. In that case, it should be possible to place digestion residues and compost on the market in the whole European Union. In addition, the competent authority of a Member State should be able to authorise certain parameters for specific animal by-products, such as catering waste and mixtures of catering waste with certain other materials, which are transformed into biogas or composted. Since such authorisations are not issued according to a harmonised model, digestion residues and compost should only be placed on the market within the Member State where the parameters have been authorised.
(14)
In order to prevent the contamination of foodstuffs with pathogenic agents, establishments or plants processing animal by-products should operate on a separate site from slaughterhouses or other establishments in which foodstuffs are processed, in particular in accordance with 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 , unless the processing of the animal by-products takes place under conditions which have been approved by the competent authority, with a view to preventing the transmission of risks to public and animal health into the food-processing establishments.
(15)
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 provides that Member States are to carry out annual monitoring programmes for transmissible spongiform encephalopathies (TSEs). Bodies of animals which are used for feeding to certain species, for the purposes of promotion of bio-diversity, should be included in those monitoring programmes to the extent necessary to ensure that those programmes provide sufficient information regarding the prevalence of TSE in a particular Member State.
(16)
Regulation (EC) No 1069/2009 allows the feeding of certain Category 1 material to endangered or protected species of necrophagous birds and to other species living in their natural habitat, for the promotion of biodiversity. Such feeding should be authorised for certain carnivore species referred to in Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora and for certain species of birds of prey referred to in Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds , in order to take into account the natural feeding patterns of those species.
(17)
Regulation (EC) No 1069/2009 has introduced a procedure for the authorisation of alternative methods of use or disposal of animal by-products or derived products. Such methods may be authorised by the Commission following receipt of an opinion from the European Food Safety Authority (hereinafter referred to as ‘EFSA’). In order to facilitate the evaluation of applications by EFSA, a standard format should be laid down which illustrates to applicants the nature of the evidence to be submitted. In accordance with the Treaties, it should be possible to submit applications for alternative methods in the official languages of the Union, as laid down in EEC Council Regulation No 1 determining the languages to the used by the European Economic Community .
(18)
In accordance with Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene , feed business operators, other than primary producers, are required to store and transport feed under certain hygienic conditions. Since those conditions provide for an equivalent mitigation of potential risks, compound feedingstuffs derived from animal by-products should not be subject to the requirements of this Regulation regarding storage and transport.
(19)
For the promotion of science and research and to ensure the best possible use of animal by-products and of derived products in the diagnosis of human or animal diseases, the competent authority should be authorised to lay down conditions for samples of such materials for research, educational and diagnostic purposes. However, those conditions should not be laid down for samples of pathogenic agents for which special rules are provided in Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC .
(20)
Directive 97/78/EC exempts animal by-products which are intended for exhibitions, provided that they are not intended to be marketed, and animal by-products intended for particular studies or analyses from veterinary checks in the border inspection post of entry into the Union. That Directive allows for the adoption of implementing measures for those exemptions. In this Regulation, appropriate conditions should be set out for the import of animal by-products and derived products intended for exhibitions and particular studies or analyses, to ensure that no unacceptable risks to public or animal health are spread where such products enter the Union. In the interests of coherency of Union legislation, and in order to provide legal certainty to operators, those conditions and the implementing measures for Directive 97/78/EC should be laid down in this Regulation.
(21)
Following collection, animal by-products should be handled under appropriate conditions which ensure that no unacceptable risks to public or animal health are transmitted. Establishments or plants in which certain operations are carried out before animal by-products are submitted to further processing should be constructed and should operate in a manner which prevents such transmission. This should include establishments or plants where operations involving the handling of animal by-products in accordance with Union veterinary legislation, other than the handling of animal by-products in the course of curative activities of private veterinarians, are carried out.
(22)
Pursuant to Regulation (EC) No 1069/2009, operators are to ensure that animal by-products and derived products are traceable at all stages of the chain of manufacturing, use and disposal, so as to avoid unnecessary disruptions of the internal market in the case of events which are linked to actual or potential risks to public or animal health. Traceability should therefore not only be ensured by operators generating, collecting or transporting animal by-products, but also by operators disposing of animal by-products or derived products, by incineration, co-incineration or landfilling.
(23)
Containers and means of transport which are used for animal by-products or derived products should be maintained in a clean state, so as to prevent contamination. When they are dedicated to the transport of a particular material, such as a liquid animal by-product which does not pose an unacceptable health risk, operators may adjust their measures to ensure the prevention of contamination to the actual risk arising from that material.
(24)
Member States should be authorised to require operators to use the integrated computerised veterinary system (Traces) introduced by Commission Decision 2004/292/EC of 30 March 2004 on the introduction of the Traces system and amending Decision 92/486/EEC (hereinafter referred to as ‘the TRACES system’) in order to provide proof for the arrival of consignments of animal by-products or derived products at the place of destination. Alternatively, proof for the arrival of consignments should be provided by way of a fourth copy of the commercial document, which is returned to the producer. The experience with the two alternatives should be evaluated after the first year of implementation of this Regulation.
(25)
Regulation (EC) No 853/2004 specifies certain parameters for the treatment of rendered fats, fish oil and egg products which provide an adequate control of possible health risks, when such products are used for purposes other than human consumption. Those parameters should therefore be authorised as alternatives to the treatments for animal by-products which are set out in this Regulation.
(26)
Colostrum and colostrum products should originate from bovine herds which are free of certain diseases as referred to in Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine .
(27)
The references to Council Directive 76/768/EEC of 27 July 1976 on the approximation of laws of the Member States relating to cosmetic products , to Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists , to Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products should be updated and the reference to Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs in the health rules for the trade in unprocessed manure should be updated.
(28)
Certain imported materials for the production of petfood should be handled and used under conditions which are appropriate to the risk which such materials may pose. In particular, provision should be made for their safe channelling to establishments or plants of destination where such materials, as well as Category 3 material, are incorporated into petfood. With respect to the establishments or plants of destination, the competent authority should be authorised to allow the storage of imported materials together with Category 3 material, provided the imported materials can be traced.
(29)
Regulation (EC) No 1069/2009 refers to certain derived products which may be placed on the market in accordance with conditions laid down in certain other Union legislation. That legislation also lays down conditions for the import, collection and movement of animal by-products and derived products for the manufacture of such derived products. However, Regulation (EC) No 1069/2009 applies where that other Union legislation does not lay down conditions concerning risks to public and animal health which may arise from such raw materials. Since such conditions have not been laid down regarding materials which have undergone certain stages of processing prior to their fulfilling the conditions for placing on the market under that other Union legislation, they should be laid down in this Regulation. In particular, the conditions for the import and handling of such materials inside the Union under strict control and documentation requirements should be laid down, so as to prevent the transmission of potential health risks from such materials.
(30)
In particular, adequate health conditions should be laid down in this Regulation for materials which are used for the manufacture of medicinal products in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use , of veterinary medicinal products in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products , of medical devices in accordance with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices , of in vitro diagnostic medical devices in accordance with Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices , active implantable medical devices in accordance with Council Directive 90/385/EEC of 20 June 1990 on the approximation of laws of the Member States relating to active implantable medical devices or laboratory reagents (‘the finished products’). If the risks arising from such materials are mitigated due to the purification, concentration in the product or due to the conditions under which they are handled and disposed of, only the requirements of Regulation (EC) No 1069/2009 and of this Regulation in relation to traceability should apply. In such case, the requirements related to the separation of animal by-products of different categories within the establishment or plant producing the finished products should not apply, since the subsequent use of materials for other purposes, in particular their diversion into food or feed can be excluded by the proper application of the rules by the operator, under the responsibility of the competent authority. Consignments of such materials which are to be imported into the Union should be subject to veterinary checks at the border inspection post of entry in accordance with Directive 97/78/EC, in order to ascertain that those products comply with the requirements for their placing on the market within the Union.
(31)
Pursuant to Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and import from third countries of equidae , certain diseases to which equidae are susceptible are compulsorily notifiable. Blood products from equidae which are intended for purposes other than for feeding, such as blood products intended for veterinary medicinal products, should originate from equidae which did not show clinical signs of those diseases, in order to mitigate the risk of transmission of those diseases.
(32)
It should be permissible to place on the market fresh hides and skins for purposes other than human consumption, provided they comply with the animal health conditions for fresh meat laid down in accordance with Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption , since those conditions provide for an appropriate mitigation of possible health risks.
(33)
The health rules laid down in this Regulation for the manufacture and placing on the market of game trophies and other preparations from animals which eliminate potential risks should be in addition to the rules for the protection of certain species of wild animals laid down in Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein , due to the different objective of that Regulation. Anatomical preparations of animals or animal by-products which have been submitted to a process such as plastination which equally eliminates potential risks should not be subject to animal health restrictions, in order to facilitate the use of such preparations, in particular in education.
(34)
Apiculture by-products which are to be placed on the market should be free of certain diseases to which bees are susceptible that are listed in Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC .
(35)
The European Parliament and the Council have called upon the Commission to determine an end point in the manufacturing chain for oleochemical products, beyond which they are no longer subject to the requirements of Regulation (EC) No 1069/2009. The decision regarding that end point should be taken as soon as an assessment has become available which evaluates the capacity of the oleochemical processes to mitigate potential health risks which may be present in animal fats of any category of material which are processed.
(36)
Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements should be referred to in this Regulation, in so far as those third countries and other territories should be authorised for the importation of certain animal by-products or derived products, since the risks which arise from those products are identical to those which potentially arise from the import of live animals or fresh meat.
(37)
Further lists of third countries from which certain materials of animal origin may be imported should be referred to for the purposes of determining the third countries from which animal by-products of the respective species may be imported, on the basis of similar considerations concerning health risks and in order to ensure coherency of Union legislation. Such lists have been laid down in Commission Decision 2004/211/EC of 6 January 2004 establishing the list of third countries and parts of territory thereof from which Member States authorise imports of live equidae and semen, ova and embryos of the equine species and amending Decisions 93/195/EEC and 94/63/EC , Commission Regulation (EU) No 605/2010 of 2 July 2010 laying down animal and public health and veterinary certifications conditions for introduction into the European Union of raw milk and dairy products intended for human consumption , Commission Decision 2006/766/EC of 6 November 2006 establishing the lists of third countries and territories from which imports of bivalve molluscs, echinoderms, tunicates, marine gastropods and fishery products are permitted , Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements and Commission Regulation (EC) No 119/2009 of 9 February 2009 laying down a list of third countries or parts thereof, for imports into, or transit through, the Community of meat of wild leporidae, of certain wild land mammals and of farmed rabbits and the veterinary certification requirements .
(38)
Since waste from the photographic industry which uses certain animal by-products such as bovine vertebral column does not only pose risks to public and animal health, but also risks to the environment, it should either be disposed of or exported to the third country of origin of the animal by-products in accordance with Regulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments of waste .
(39)
The list of border inspection posts laid down in 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 should be referred to in the rules for the transit of certain animal by-products and derived products through the European Union between territories of the Russian Federation. The Common Veterinary Entry Document laid down in Commission Regulation (EC) No 136/2004 of 22 January 2004 laying down procedures for veterinary checks at Community border inspection posts on products imported from third countries should be used for the purposes of that transit.
(40)
This Regulation should provide that the health certificates which are to accompany consignments of animal by-products or derived products at the point of entry into the Union where the veterinary checks take place should be issued in accordance with principles of certification equivalent to those laid down in Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products .
(41)
In the interests of consistency of Union legislation, official controls on the entire chain of animal by-products and derived products should be carried out in accordance with the general obligations for official controls which are laid down in Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules .
(42)
It is therefore necessary to lay down implementing measures for Regulation (EC) No 1069/2009 in this Regulation.
(43)
Regulation (EC) No 1069/2009 repeals Regulation (EC) No 1774/2002 with effect from 4 March 2011.
(44)
Following the adoption of Regulation (EC) No 1774/2002, certain implementing acts were adopted, namely Commission Regulation (EC) No 811/2003 on the intra-species recycling ban for fish, and the burial and burning of certain animal by-products, Commission Decision 2003/322/EC on the feeding of certain necrophagous birds with certain Category 1 materials, Commission Decision 2003/324/EC on a derogation from the intra-species recycling ban for fur animals, Commission Regulations (EC) No 79/2005 on milk and milk-based products, (EC) No 92/2005 on means of disposal or uses, (EC) No 181/2006 on organic fertilisers and soil improvers other than manure, (EC) No 1192/2006 on lists of approved plants and (EC) No 2007/2006 on the importation and transit of certain Category 3 intermediate products.
(45)
In addition, certain transitional measures were adopted, in particular Commission Regulation (EC) No 878/2004 on the import and handling of certain Category 1 and Category 2 materials, Commission Decision 2004/407/EC on the import of certain materials for the production of photogelatine and Commission Regulation (EC) No 197/2006 on handling and disposal of former foodstuffs, to lay down risk-proportionate measures for certain specific uses of animal by-products.
(46)
In order to further simplify Union rules for animal by-products, as requested by the Presidency of the Council at the time of the adoption of Regulation (EC) No 1069/2009, those implementing and transitional measures were reviewed. They should now be repealed and replaced, as necessary, by this Regulation, so as to constitute a coherent legal framework for animal by-products and derived products.
(47)
Regulation (EC) No 1069/2009 applies from 4 March 2011 and accordingly this Regulation should also apply from that date. In addition, it is necessary to provide for a transitional period, in order to give stakeholders time to adjust to the new rules laid down in this Regulation and to place on the market certain products which were produced in accordance with Union health rules applicable before that date, and to allow for a continuation of imports when the requirements of this Regulation become applicable.
(48)
The placing on the market and the export of certain products referred to in Regulation (EC) No 878/2004 should continue to be carried out in accordance with national measures, since the associated risks for the limited amount of materials involved currently allow their regulation at national level, pending possible future harmonisation. Pending the adoption of measures for the collection and disposal of certain limited amounts of products of animal origin from the retail sector on the basis of further evidence, the competent authority should continue to be able to authorise the collection and disposal of such products by other means, provided that an equivalent protection of public and animal health is ensured.
(49)
In accordance with the request expressed by the European Parliament at the time of its agreement to Regulation (EC) No 1069/2009 at first reading, and taking into account the Parliament's more specific suggestions for addressing certain technical issues, a draft of this Regulation has been presented on 27 September 2010 to its Committee for the Environment, Public Health and Food Safety for an exchange of views.
(50)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
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