CELEX: 
Language: en
Date: 2016-11-10
Title: COMMISSION REGULATION (EU) …/… amending Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the requirements for the removal of specified risk materials from small ruminants

COMMISSION REGULATION (EU) …/…
            
            
               of XXX
            
            
               amending Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the requirements for the removal of specified risk materials from small ruminants
            
            
               (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 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
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               , and in particular the first paragraph of Article 23 thereof,
            
            
               Whereas:
            
            
               (1)Regulation (EC) No 999/2001 lays down rules for the prevention, control and eradication of transmissible spongiform encephalopathies (TSEs) in animals. It applies to the production and placing on the market of live animals and products of animal origin and in certain specific cases to exports thereof.
            
            
               (2)In addition, Regulation (EC) No 999/2001 provides that Member States and third countries or regions thereof are classified according to their risk of bovine spongiform encephalopathy (BSE) into countries or regions with a negligible BSE risk, a controlled BSE risk or an undetermined BSE risk. Regulation (EC) No 999/2001 also defines specified risk material as the tissues listed in Annex V thereto, and it provides that specified risk material is to be removed and disposed of in accordance with Annex V thereto and with Regulation (EC) No 1069/2009
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               . 
            
            
               (3)In order to address animal and public health risks associated with BSE in small ruminants, point 1(b) of Annex V to Regulation (EC) No 999/2001 designates certain ovine and caprine tissues as specified risk material if they come from animals whose origin is in a Member State or third country, or in one of their regions, with a controlled BSE risk or an undetermined BSE risk status. Point 2 of that Annex extends the list of ovine and caprine tissues designated as specified risk material to include tissues which are derived from animals whose origin is in a Member State with a negligible BSE risk status, but it does not impose this requirement on to third countries with the same status. Accordingly, Member States with a negligible BSE risk status are required to remove and dispose of specified risk material, while imports into the Union of such tissues from third countries with a negligible BSE risk status are allowed.
            
            
               (4)The recommendations of the World Organisation for Animal Health ('OIE') concerning BSE, set out in Chapter 11.4 of the OIE Terrestrial Animal Health Code
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               , apply to the BSE agent in cattle only. Thus, as far as ovine and caprine animals are concerned, the OIE does not define any list of tissues that should not be traded due to their BSE risk.
            
            
               (5)The Commission Strategy Paper on Transmissible Spongiform Encephalopathies for 2010-2015
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                envisages the possibility to review the current requirement for Member States with a negligible BSE risk status to remove specified risk material from the food and feed chain if an increasing number of Member States obtain that status. Commission Decision 2007/453/EC
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               , as amended by Commission Implementing Decision (EU) 2016/1100
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               , which was adpopted following OIE Resolution No 20 of May 2016
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               , now lists 23 Union Member States as having a negligible BSE risk status. 
            
            
               (6)On 2 December 2010, the European Food Safety Authority (EFSA) published a Scientific Opinion on BSE/TSE infectivity in small ruminant tissues ('the 2010 EFSA opinion')
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               . In that opinion, EFSA estimated that the number of small ruminants infected with BSE that could enter the food chain in the Union each year is very limited, and confirmed that these estimates argue against any widespread BSE epidemic in the small ruminant population in the Union. 
            
            
               (7)As mentioned in the Joint Scientific Opinion on any possible epidemiological or molecular association between TSEs in animals and humans adopted by EFSA and the European Centre for Disease Prevention and Control on 9 December 2010
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               , only two cases of BSE occurring in natural conditions have been reported worldwide in caprine animals and no naturally occurring BSE case have been reported in ovine animals. The two natural BSE cases detected in goats were born before the introduction of the prohibition on the feeding of processed animal protein to farmed animals and at a time where the BSE epidemic in bovine animals was reaching a peak. 
            
            
               (8)On 5 August 2015, EFSA published a Scientific Opinion on a request for a review of a scientific publication concerning the zoonotic potential of ovine scrapie prions
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               . In that opinion, EFSA concluded that there is no evidence of a causal link between scrapie and human TSEs and confirmed that the only TSE agent demonstrated to be zoonotic is the classical BSE agent. Furthermore, EFSA highlighted that there is no epidemiological evidence to suggest that scrapie is zoonotic, in particular since the incidence of sporadic Creutzfeldt Jakob Disease in humans is similar in countries with minimal incidence of scrapie as in countries with high incidence of scrapie. 
            
            
               (9)It is therefore appropriate to amend the existing requirements for the removal of specified risk material in small ruminants originating from Member States with a negligible BSE risk, so that only those tissues which concentrate the highest levels of BSE infectivity in an infected small ruminant are designated as specified risk material. According to the 2010 EFSA opinion, experimental data show that the highest level of infectivity in ovine animals inoculated with BSE is found in the brain. 
            
            
               (10)Given the practical difficulties to ensure the absence of contamination of the bones of the skull with brain tissues, the skull of ovine and caprine animals over 12 months of age, or which have a permanent incisor erupted through the gum, and whose origin is in a Member State with a negligible BSE risk status, should remain designated as specified risk material in Annex V to Regulation (EC) No 999/2001. 
            
            
               (11)Therefore, only the brain, the skull and the eyes of ovine and caprine animals over 12 months of age, or which have a permanent incisor erupted through the gum should be considered as specified risk materials in ovine and caprine animals whose origin is in a Member State with a negligible BSE risk status. 
            
         
         
            
               (12)Due to the specificity of the farming of ovine and caprine animals, the determination of the exact date of birth of those animals is rarely feasible and thus such data is not included in the holding register required in accordance with Council Regulation (EC) No 21/2004
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               . Therefore, the specified risk material from ovine and caprine animals set out in point 1(b)(i) of Annex V to Regulation (EC) No 999/2001 apply if the animal is aged over 12 months or if it has a permanent incisor erupted through the gum. 
            
            
               (13)The estimation of the age of ovine and caprine animals based on dentition provides only an approximation, given that the date of eruption of the first permanent incisor in an ovine and caprine animal can vary by several months. Other methods for estimating whether ovine and caprine animals sent for slaughter are over 12 months of age can provide an equivalent level of guarantee concerning the age of the animal. As such methods may depend on the particularity of the slaughter practices of ovine and caprine animals at national level, the reliability of such methods should be evaluated by the competent authority of the Member State of slaughter. Point 1(b) of Annex V to Regulation (EC) No 999/2001 should therefore be amended to provide the possibility of estimating whether an animal is over 12 months of age by a method approved by the competent authority of the Member State of slaughter. 
            
            
               (14)Annex V to Regulation (EC) No 999/2001 should be amended accordingly. 
            
            
               (15)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 V to Regulation (EC) No 999/2001 is amended as follows:
            
            
               1.In point 1, (b) is replaced by the following: 
            
            
               '(b)as regards ovine and caprine animals:
            
            
               (i)the skull, including the brain and eyes, of animals aged over 12 months, whose age may be estimated by a method approved by the competent authority of the Member State of slaughter, or which have a permanent incisor erupted through the gum;
            
            
               (ii)the tonsils and the spinal cord of animals aged over 12 months, whose age may be estimated by a method approved by the competent authority of the Member State of slaughter, or which have a permanent incisor erupted through the gum; and
            
            
               (iii)the spleen and ileum of animals of all ages.'. 
            
            
               2.Point 2 is replaced by the following: 
            
            
               '2.Specific requirements for Member States with a negligible BSE risk status
            
            
               Tissues listed in point 1(a)(i) and 1(b)(i), which are derived from animals whose origin is in Member States with a negligible BSE risk, shall be considered as specified risk material.'.
            
            
               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,
            
            
               
                     For the Commission
               
            
         
         
            
               
                     The President
               
               
                     Jean-Claude JUNCKER
               
            
         
         
            
                  
                     (1)
                  OJ L 147, 31.5.2001, p. 1.
               
               
                  
                     (2)
                  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 (OJ L 300, 14.11.2009, p.1).
               
               
                  
                     (3)
                  http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_bse.htm. 
               
               
                  
                     (4)
                  Communication from the Commission to the European Parliament and the Council - The TSE Road map 2 - A Strategy paper on Transmissible Spongiform Encephalopathies for 2010-2015; COM(2010)384 final.
               
               
                  
                     (5)
                  Commission Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84).
               
               
                  
                     (6)
                  Commission Implementing Decision (EU) 2016/1100 of 5 July 2016 amending the Annex to Decision 2007/453/EC as regards the BSE status of Costa Rica, Germany, Lithuania, Namibia and Spain (OJ L 182, 7.7.2016, p. 47).
               
               
                  
                     (7)
                  Resolution No. 20, 'Recognition of the Bovine Spongiform Encephalopathy Risk Status of Member Countries', adopted by the World Assembly of Delegates of the OIE on 24 May 2016 (84 GS/FR – Paris, May 2016).
               
               
                  
                     (8)
                  EFSA Journal 2010; 8(12):1875 [92 pp.].
               
               
                  
                     (9)
                  EFSA Journal 2011; 9(1):1945 [111 pp.].
               
               
                  
                     (10)
                  EFSA Journal 2015; 13(8):4197 [58 pp.].
               
               
                  
                     (11)
                  Council Regulation (EC) No 21/2004 of 17 December 2003 establishing a system for the identification and registration of ovine and caprine animals and amending Regulation (EC) No 1782/2003 and Directives 92/102/EEC and 64/432/EEC (OJ L 5, 9.1.2004, p. 8).