Commission Regulation (EU) No 1063/2012 of 13 November 2012 amending Regulation (EU) No 142/2011 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

Commission Regulation (EU) No 1063/2012of 13 November 2012amending Regulation (EU) No 142/2011 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 1774/2002OJ L 300, 14.11.2009, p. 1., and in particular Article 21(6)(d) and Article 40(b), (d) and (f) thereof,Whereas:(1)Regulation (EC) No 1069/2009 lays down public and animal health rules for animal by-products and derived products, in order to prevent and minimise risks to public and animal health arising from those products. Wool and hair obtained from animals that did not show any signs of disease communicable through that product to humans or animals should be declared as a Category 3 material referred to in Article 10(h) and (n) of that Regulation.(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 DirectiveOJ L 54, 26.2.2011, p. 1., amongst other things lays down implementing rules for placing on the market of wool and hair.(3)Dry untreated wool and hair securely enclosed in packaging do not present a risk of spreading disease, provided they are dispatched directly to a plant producing derived products for uses outside the feed chain or to a plant carrying out intermediate operations under conditions which prevent the spreading of pathogenic agents. Member States should therefore have the possibility to exempt operators which transport such untreated wool and hair directly to the above mentioned plant from the obligation to notify provided for in Article 23(1)(a) of Regulation (EC) No 1069/2009. Article 20(4) of Regulation (EU) No 142/2011 should therefore be amended accordingly.(4)Point B of Chapter VII of Annex XIII to Regulation (EU) No 142/2011 provides the end point for wool and hair.(5)Article 8.5.35 of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE)http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_1.8.5.htm, provides for a list of procedures for the inactivation of the foot-and-mouth disease virus in wool and hair of ruminants for industrial use.(6)Therefore, the current treatments for placing on the market within the EU, as well as for imports from third countries, of wool and hair laid down in Article 25(2) of Regulation (EU) No 142/2011 should be supplemented by internationally recognised procedures for the inactivation of the foot-and-mouth disease virus in wool and hair of ruminants for industrial use.(7)However, Member States have the opportunity to accept any other method which ensures that no unacceptable risks remain after treatment of wool and hair including a factory washing method which is different to OIE standards.(8)Untreated wool and hair of ruminants intended for the textile industry do not present an unacceptable animal health risk, provided they are produced from ruminants kept in countries or regions listed in Part 1 of Annex II to 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 requirementsOJ L 73, 20.3.2010, p. 1. and authorised for imports into the Union of fresh meat of ruminants not subject to supplementary guarantees A and F mentioned therein.(9)In addition the third country or region thereof of origin of the wool and hair should be free of foot-and-mouth disease and, in the case of wool and hair from sheep and goats, of sheep pox and goat pox in accordance with the basic general criteria listed in Annex II to Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EECOJ L 226, 25.6.2004, p. 128..(10)In order to provide operators with a sufficiently wide range of methods and procedures to mitigate the risks posed by trade in and imports of wool and hair, complementary requirements should be laid down for placing on the market of wool and hair imported from third countries without restrictions in accordance with Regulation (EU) No 142/2011. Article 25(2) of Regulation (EU) No 142/2011 should be amended accordingly.(11)For reasons of clarity the rules for imports of untreated wool and hair laid down in row 8 of Table 2 of Section 1 of Chapter II of Annex XIV to Regulation (EU) No 142/2011 should be amended accordingly.(12)Porcine animals are susceptible to transmission of diseases other than foot-and-mouth disease, in particular of African swine fever, which require specific treatment of wool and hair produced from animals of the porcine species. Placing on the market and as consequence the import from third countries of wool and hair of porcine animals should therefore be subject to the same conditions as laid down for pig bristles. Point A(2) of Chapter VII of Annex XIII to Regulation (EU) No 142/2011 should therefore be amended accordingly.(13)The additional treatments for wool and hair produced from animals other than those of the porcine species, which is dispatched directly to a plant producing derived products from wool and hair for the textile industry should also be available for operators in the Member States. Point B of Chapter VII of Annex XIII to Regulation (EU) No 142/2011 should therefore be supplemented accordingly.(14)Imports into the Union of untreated wool and hair from particular third countries or regions thereof should be authorised provided that they meet the necessary requirements and are accompanied by an importer's declaration in accordance with the model provided for in the Annex IV to this Regulation. That declaration is to be presented at one of the approved Union border inspection posts listed in Annex I to 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 TracesOJ L 296, 12.11.2009, p. 1., where they should undergo, by way of derogation from Article 4(4) of Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organization of veterinary checks on products entering the Community from third countriesOJ L 24, 30.1.1998, p. 9. the documentary checks provided for in Article 4(3) of that Directive.(15)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 the Food Chain and Animal Health,HAS ADOPTED THIS REGULATION:

Article 1Regulation (EU) No 142/2011 is amended as follows:(1)Article 20(4) is replaced by the following:"4.The competent authority may exempt the following operators from the obligation to notify, referred to in Article 23(1)(a) of Regulation (EC) No 1069/2009:(a)operators handling or generating game trophies or other preparations referred to in Chapter VI of Annex XIII hereto for private or non-commercial purposes;(b)operators handling or disposing research and diagnostic samples for educational purposes;(c)operators transporting dry untreated wool and hair, provided they are securely enclosed in packaging, and directly dispatched to a plant producing derived products for uses outside the feed chain or to a plant carrying out intermediate operations, under conditions which prevent the spreading of pathogenic agents."(2)Article 25(2) is replaced by the following:"2.The importation into and the transit through the Union of the following shall not be subject to any animal health conditions:(a)wool and hair which has been factory-washed or which has been treated by another method which ensures that no unacceptable risks remain;(b)furs which have been dried at an ambient temperature of 18°C for a period of at least two days at a humidity of 55 %;(c)wool and hair produced from animals other than those of the porcine species, which has been treated by factory-washing which consisting of the immersion of the wool and hair in series of baths of water, soap and sodium hydroxide or potassium hydroxide;(d)wool and hair produced from animals other than those of the porcine species, which is dispatched directly to a plant producing derived products from wool and hair for the textile industry and has been treated by at least one of the following methods:chemical depilation by means of slaked lime or sodium sulphide,fumigation in formaldehyde in a hermetically sealed chamber for at least 24 hours,industrial scouring which consists of the immersion of wool and hair in a water-soluble detergent held at 60–70 °C,storage, which may include the journey time, at 37 °C for eight days, 18 °C for 28 days or 4 °C for 120 days;(e)wool and hair that is dry and securely enclosed in packaging, produced from animals other than those of the porcine species, which is intended for dispatch to a plant producing derived products from wool and hair for the textile industry and meets all of the following requirements:(i)it was produced at least 21 days before the date of entry into the Union kept in a third country or region thereof which islisted in Part 1 of Annex II to Regulation (EU) No 206/2010 and authorised for imports into the Union of fresh meat of ruminants not subject to supplementary guarantees A and F mentioned therein,free of foot-and-mouth disease, and, in the case of wool and hair from sheep and goats, of sheep pox and goat pox in accordance with the basic general criteria listed in Annex II to Directive 2004/68/EC;(ii)it is accompanied by a importers' declaration as required in accordance with Chapter 21 of Annex XV;(iii)it was presented by the operator to one of the approved Union border inspection posts listed in Annex I to Decision 2009/821/EC where it passed with satisfactory result the documentary check carried out in accordance with Article 4(3) of Directive 97/78/EC."(3)Points 31 and 32 of Annex I shall be replaced by the text in Annex I to this Regulation.(4)Points A(2) and B of Chapter VII of Annex XIII shall be amended in accordance with the text in Annex II to this Regulation.(5)Row 8 of Table 2 of Section 1 of Chapter II of Annex XIV shall be replaced by the text in Annex III to this Regulation.(6)The text in Annex IV to this Regulation shall be added to Annex XV.

Article 2This 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, 13 November 2012.For the CommissionThe PresidentJosé Manuel BarrosoANNEX IPoints 31 and 32 of Annex I to Regulation (EU) No 142/2011 shall be replaced by the following:"31."untreated wool" means wool, other than wool which has:(a)undergone factory washing;(b)been obtained from tanning;(c)been treated by another method that ensures that no unacceptable risks remain;(d)been produced from animals other than those of the porcine species, and has undergone factory-washing which consisting of the immersion of the wool in series of baths of water, soap and sodium hydroxide or potassium hydroxide; or(e)been produced from animals other than those of the porcine species, is intended for being dispatched directly to a plant producing derived products from wool for the textile industry and has undergone at least one of the following treatments:(i)chemical depilation by means of slaked lime or sodium sulphide;(ii)fumigation in formaldehyde in a hermetically sealed chamber for at least 24 hours;(iii)industrial scouring which consists of the immersion of wool in a water-soluble detergent held at 60–70 °C;(iv)storage, which may include the journey time, at 37 °C for eight days, 18 °C for 28 days or 4 °C for 120 days;32."untreated hair" means hair, other than hair which has:(a)undergone factory washing;(b)been obtained from tanning;(c)been treated by another method that ensures that no unacceptable risks remain;(d)been produced from animals other than those of the porcine species, and has undergone factory-washing which consisting of the immersion of the hair in series of baths of water, soap and sodium hydroxide or potassium hydroxide; or(e)been produced from animals other than those of the porcine species, is intended for being dispatched directly to a plant producing derived products from hair for the textile industry and has undergone at least one of the following treatments:(i)chemical depilation by means of slaked lime or sodium sulphide;(ii)fumigation in formaldehyde in a hermetically sealed chamber for at least 24 hours;(iii)industrial scouring which consists of the immersion of hair in a water-soluble detergent held at 60–70 °C;(iv)storage, which may include the journey time, at 37 °C for eight days, 18 °C for 28 days or 4 °C for 120 days;"ANNEX IIChapter VII of Annex XIII to Regulation (EU) No 142/2011 shall be amended as follows:(1)The introductory phrase of point A(2) is replaced by the following:"2.Movements of pig bristles and wool and hair of animals of the porcine species from regions in which African swine fever is endemic shall be prohibited except for pig bristles and wool and hair of animals of the porcine species that have:".(2)The following paragraph is added to point B:"Wool and hair produced from animals other than those of the porcine species may be placed on the market without restrictions in accordance with this Regulation, provided:(a)it has undergone factory-washing which consists of the immersion of the wool and hair in series of baths of water, soap and sodium hydroxide or potassium hydroxide; or(b)it is dispatched directly to a plant producing derived products from wool or hair for the textile industry and such wool or hair has undergone at least one of the following treatments:(i)chemical depilation by means of slaked lime or sodium sulphide;(ii)fumigation in formaldehyde in a hermetically sealed chamber for at least 24 hours;(iii)industrial scouring which consists of the immersion of wool and hair in a water-soluble detergent held at 60–70 °C;(iv)storage, which may include the journey time, at 37 °C for eight days, 18 °C for 28 days or 4 °C for 120 days."ANNEX IIIRow 8 of Table 2 of Section 1 of Chapter II of Annex XIV to Regulation (EU) No 142/2011 is replaced by the following:

"8	Untreated wool and hair produced from animals other than those of the porcine species	Category 3 materials referred to in Article 10(h) and (n).	(1)The dry untreated wool and hair must be(a)securely enclosed in packaging; and(b)sent directly to a plant producing derived products for uses outside the feed chain or a plant carrying out intermediate operations, under conditions which prevent the spreading of pathogenic agents.	(1)Any third country.	(1)For imports of untreated wool and hair, no health certificate is required.
			(2)The wool and hair are wool and hair as referred to in Article 25(2)(e).	(2)Third country or region thereof(a)listed in Part 1 of Annex II to Regulation (EU) No 206/2010 and authorised for imports into the Union of fresh meat of ruminants not subject to supplementary guarantees A and F mentioned therein; and(b)free of foot-and-mouth disease and, in case of wool and hair of sheep and goats, of sheep pox and goat pox in accordance with Annex II to Council Directive 2004/68/EC.	(2)A declaration of the importer in accordance with Chapter 21 of Annex XV is required."

ANNEX IVThe following Chapter 21 is added to Annex XV to Regulation (EU) No 142/2011:"CHAPTER 21Model declarationDeclaration by the importer of untreated wool and hair referred to in Article 25(2)(e) for import to the European Union