32007R1245•Commission Regulation (EC) No 1245/2007 of 24 October 2007 amending Annex I to Regulation (EC) No 2075/2005, as regards the use of liquid pepsin for the detection of Trichinella in meat (Text with EEA relevance)
32007R1245RegulationNov 14, 2007
of 24 October 2007
amending Annex I to Regulation (EC) No 2075/2005, as regards the use of liquid pepsin for the detection of Trichinella in meat
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption 1 , and in particular Article 18(9) and (10) thereof,
Whereas:
(1) Commission Regulation (EC) No 2075/2005 of 5 December 2005 laying down specific hygiene rules on official controls for Trichinella in meat 2 provides for methods of detection of Trichinella in samples of carcases. The reference method laid down in Annex I to that Regulation requires that for the detection of Trichinella larvae in meat samples, 10 ± 0,2 g of pepsin is to be added to the sample.
(2) Reports have been published 3 indicating that pepsin powder can cause allergic reactions in certain susceptible individuals.
(3) Investigations by the Community Reference Laboratory for Parasites indicated that the sensitivity of the reference method of detection for Trichinella is not altered when liquid pepsin is used according to the manufacturer's specifications instead of pepsin powder. Such an alternative should therefore be provided both for the reference method and the equivalent method of detection of Trichinella in meat.
(4) Regulation (EC) No 2075/2005 should therefore be amended accordingly.
(5) The measures provided in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
Annex I to Regulation (EC) No 2075/2005 is amended as follows:
| 1. | (a): Point 1(p) is replaced by the following: ‘(p) Pepsin, strength: 1: 10 000 NF (US National Formulary) corresponding to 1: 12 500 BP (British Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie), or stabilized liquid pepsin with minimum 660 European Pharmacopoeia units/ml’, — ‘(p) — Pepsin, strength: 1: 10 000 NF (US National Formulary) corresponding to 1: 12 500 BP (British Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie), or stabilized liquid pepsin with minimum 660 European Pharmacopoeia units/ml’, ‘(p): Pepsin, strength: 1: 10 000 NF (US National Formulary) corresponding to 1: 12 500 BP (British Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie), or stabilized liquid pepsin with minimum 660 European Pharmacopoeia units/ml’, | (a) | ‘(p): Pepsin, strength: 1: 10 000 NF (US National Formulary) corresponding to 1: 12 500 BP (British Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie), or stabilized liquid pepsin with minimum 660 European Pharmacopoeia units/ml’, | ‘(p) | Pepsin, strength: 1: 10 000 NF (US National Formulary) corresponding to 1: 12 500 BP (British Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie), or stabilized liquid pepsin with minimum 660 European Pharmacopoeia units/ml’, | (b) | ‘(b): 10 ± 0,2 g of pepsin or 30 ± 0,5 ml liquid pepsin is added.’ | ‘(b) | 10 ± 0,2 g of pepsin or 30 ± 0,5 ml liquid pepsin is added.’ |
|---|---|---|---|---|---|---|---|---|---|
| (a) | ‘(p): Pepsin, strength: 1: 10 000 NF (US National Formulary) corresponding to 1: 12 500 BP (British Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie), or stabilized liquid pepsin with minimum 660 European Pharmacopoeia units/ml’, | ‘(p) | Pepsin, strength: 1: 10 000 NF (US National Formulary) corresponding to 1: 12 500 BP (British Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie), or stabilized liquid pepsin with minimum 660 European Pharmacopoeia units/ml’, | ||||||
| ‘(p) | Pepsin, strength: 1: 10 000 NF (US National Formulary) corresponding to 1: 12 500 BP (British Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie), or stabilized liquid pepsin with minimum 660 European Pharmacopoeia units/ml’, | ||||||||
| (b) | ‘(b): 10 ± 0,2 g of pepsin or 30 ± 0,5 ml liquid pepsin is added.’ | ‘(b) | 10 ± 0,2 g of pepsin or 30 ± 0,5 ml liquid pepsin is added.’ | ||||||
| ‘(b) | 10 ± 0,2 g of pepsin or 30 ± 0,5 ml liquid pepsin is added.’ |
| 2. | (a): Point A. 1. (q) is replaced by the following: ‘(q) Pepsin, strength: 1: 10 000 NF (US National Formulary) corresponding to 1: 12 500 BP (British Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie), or stabilized liquid pepsin with minimum 660 European Pharmacopoeia units/ml’, — ‘(q) — Pepsin, strength: 1: 10 000 NF (US National Formulary) corresponding to 1: 12 500 BP (British Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie), or stabilized liquid pepsin with minimum 660 European Pharmacopoeia units/ml’, ‘(q): Pepsin, strength: 1: 10 000 NF (US National Formulary) corresponding to 1: 12 500 BP (British Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie), or stabilized liquid pepsin with minimum 660 European Pharmacopoeia units/ml’, | (a) | ‘(q): Pepsin, strength: 1: 10 000 NF (US National Formulary) corresponding to 1: 12 500 BP (British Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie), or stabilized liquid pepsin with minimum 660 European Pharmacopoeia units/ml’, | ‘(q) | Pepsin, strength: 1: 10 000 NF (US National Formulary) corresponding to 1: 12 500 BP (British Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie), or stabilized liquid pepsin with minimum 660 European Pharmacopoeia units/ml’, | (b) | ‘(v): Lastly, 6 g pepsin or 18 ml liquid pepsin is added. This order must be followed strictly to avoid decomposition of the pepsin.’, | ‘(v) | Lastly, 6 g pepsin or 18 ml liquid pepsin is added. This order must be followed strictly to avoid decomposition of the pepsin.’, | (c) | ‘(h): Lastly, add 7 g of pepsin or 21 ml liquid pepsin. This order must be followed strictly to avoid decomposition of the pepsin.’ | ‘(h) | Lastly, add 7 g of pepsin or 21 ml liquid pepsin. This order must be followed strictly to avoid decomposition of the pepsin.’ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (a) | ‘(q): Pepsin, strength: 1: 10 000 NF (US National Formulary) corresponding to 1: 12 500 BP (British Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie), or stabilized liquid pepsin with minimum 660 European Pharmacopoeia units/ml’, | ‘(q) | Pepsin, strength: 1: 10 000 NF (US National Formulary) corresponding to 1: 12 500 BP (British Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie), or stabilized liquid pepsin with minimum 660 European Pharmacopoeia units/ml’, | ||||||||||
| ‘(q) | Pepsin, strength: 1: 10 000 NF (US National Formulary) corresponding to 1: 12 500 BP (British Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie), or stabilized liquid pepsin with minimum 660 European Pharmacopoeia units/ml’, | ||||||||||||
| (b) | ‘(v): Lastly, 6 g pepsin or 18 ml liquid pepsin is added. This order must be followed strictly to avoid decomposition of the pepsin.’, | ‘(v) | Lastly, 6 g pepsin or 18 ml liquid pepsin is added. This order must be followed strictly to avoid decomposition of the pepsin.’, | ||||||||||
| ‘(v) | Lastly, 6 g pepsin or 18 ml liquid pepsin is added. This order must be followed strictly to avoid decomposition of the pepsin.’, | ||||||||||||
| (c) | ‘(h): Lastly, add 7 g of pepsin or 21 ml liquid pepsin. This order must be followed strictly to avoid decomposition of the pepsin.’ | ‘(h) | Lastly, add 7 g of pepsin or 21 ml liquid pepsin. This order must be followed strictly to avoid decomposition of the pepsin.’ | ||||||||||
| ‘(h) | Lastly, add 7 g of pepsin or 21 ml liquid pepsin. This order must be followed strictly to avoid decomposition of the pepsin.’ |
This Regulation shall enter into force on the 20th 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, 24 October 2007. For the Commission Markos KYPRIANOU Member of the Commission
1 OJ L 139, 30.4.2004, p. 206 , as corrected by OJ L 226, 25.6.2004, p. 83 . Regulation as last amended by Council Regulation (EC) No 1791/2006 ( OJ L 363, 20.12.2006, p. 1 ).
2 OJ L 338, 22.12.2005, p. 60 . Regulation as amended by Regulation (EC) No 1665/2006 ( OJ L 320, 18.11.2006, p. 46 ).
3 J Investig Allergol Clin Immunol (2006) 16, 136-137.
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"title": "Commission Regulation (EC) No 1245/2007 of 24 October 2007 amending Annex I to Regulation (EC) No 2075/2005, as regards the use of liquid pepsin for the detection of Trichinella in meat (Text with EEA relevance)",
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"title": "Regolamento (CE) n. 1245/2007 della Commissione, del 24 ottobre 2007 , recante modifica dell’allegato I del regolamento (CE) n. 2075/2005 per quanto riguarda l’uso di pepsina liquida per rilevare Trichinella spp. nelle carni (Testo rilevante ai fini del SEE)",
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"title": "Verordnung (EG) Nr. 1245/2007 der Kommission vom 24. Oktober 2007 zur Änderung von Anhang I der Verordnung (EG) Nr. 2075/2005 hinsichtlich der Verwendung von flüssigem Pepsin zum Nachweis von Trichinen in Fleisch (Text von Bedeutung für den EWR)",
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