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ISSN 1725-2555 Official Journal L 325 of the European Union Volume 50 English edition Legislation 11 December 2007 Contents I Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory REGULATIONS Commission Regulation (EC) No 1450/2007 of 10 December 2007 establishing the standard import values for determining the entry price of certain fruit and vegetables ............................... 1 ★ Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (1)3 ★ Commission Regulation (EC) No 1452/2007 of 7 December 2007 concerning the classification of certain goods in the Combined Nomenclature ............................................... 66 ★ Commission Regulation (EC) No 1453/2007 of 10 December 2007 fixing the standard fee per farm return for the 2008 accounting year of the farm accountancy data network ............ 68 ★ Commission Regulation (EC) No 1454/2007 of 10 December 2007 laying down common rules for establishing a tender procedure for fixing export refunds for certain agricultural products 69 ★ Commission Regulation (EC) No 1455/2007 of 10 December 2007 opening certain Community import quotas for rice originating in Egypt ..................................................... 74 ★ Commission Regulation (EC) No 1456/2007 of 10 December 2007 amending Regulations (EC) No 2058/96, (EC) No 2375/2002, (EC) No 2377/2002, (EC) No 2305/2003, (EC) No 955/2005, (EC) No 969/2006 and (EC) No 1964/2006 opening and providing for the administration of tariff quotas for imports of rice and cereals .................................................... 76 1 ( ) Text with EEA relevance (Continued overleaf) Price: EUR 18 Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. EN The titles of all other acts are printed in bold type and preceded by an asterisk. Contents (continued) Commission Regulation (EC) No 1457/2007 of 10 December 2007 amending the representative prices and additional duties for the import of certain products in the sugar sector fixed by Regulation (EC) No 1109/2007 for the 2007/2008 marketing year ................................................. 81 II Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory DECISIONS Council 2007/810/EC: ★ Council Decision of 19 November 2007 on the conclusion, on behalf of the European Community and its Member States, of a Protocol to the Agreement on Cooperation and Customs Union between the European Economic Community and the Republic of San Marino, regarding the participation, as contracting parties, of the Republic of Bulgaria and Romania, following their accession to the European Union .................................... 83 Protocol to the agreement on cooperation and customs Union between the European Economic Community and the Republic of San Marino, regarding the participation, as contracting parties, of the Republic of Bulgaria and Romania, following their accession to the European Union ................... 84 Conference of the Representatives of the Governments of the Member States 2007/811/EC, Euratom: ★ Decision of the Representatives of the Governments of the Member States of 5 December 2007 appointing a judge to the Court of Justice of the European Communities ............... 89 Commission 2007/812/EC: ★ Commission Decision of 28 November 2007 on the allocation to the Netherlands of three additional days at sea for an enhanced observer coverage programme in accordance with Annex IIA to Council Regulation (EC) No 41/2007 (notified under document number C(2007) 5711) 90 2007/813/EC: ★ Commission Decision of 28 November 2007 on the allocation to Spain of additional days at sea within ICES Divisions VIIIc and IXa excluding the Gulf of Cadiz (notified under document number C(2007) 5719) ..................................................................................... 92 EN 11.12.2007EN Official Journal of the European Union L 325/1 I (Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory) REGULATIONS COMMISSION REGULATION (EC) No 1450/2007 of 10 December 2007 establishing the standard import values for determining the entry price of certain fruit and vegetables THE COMMISSION OF THE EUROPEAN COMMUNITIES, standard values for imports from third countries, in respect of the products and periods stipulated in the Annex thereto. Having regard to the Treaty establishing the European Community, (2) In compliance with the above criteria, the standard import values must be fixed at the levels set out in the Annex to this Regulation, Having regard to Commission Regulation (EC) No 3223/94 of 21 December 1994 on detailed rules for the application of the HAS ADOPTED THIS REGULATION: import arrangements for fruit and vegetables (1), and in particular Article 4(1) thereof, Article 1 The standard import values referred to in Article 4 of Regu- Whereas: lation (EC) No 3223/94 shall be fixed as indicated in the Annex hereto. (1) Regulation (EC) No 3223/94 lays down, pursuant to the Article 2 outcome of the Uruguay Round multilateral trade nego- tiations, the criteria whereby the Commission fixes the This Regulation shall enter into force on 11 December 2007. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 10 December 2007. For the Commission Jean-Luc DEMARTY Director-General for Agriculture and Rural Development (1) OJ L 337, 24.12.1994, p. 66. Regulation as last amended by Regu- lation (EC) No 756/2007 (OJ L 172, 30.6.2007, p. 41). L 325/2EN Official Journal of the European Union 11.12.2007 ANNEX to Commission Regulation of 10 December 2007 establishing the standard import values for determining the entry price of certain fruit and vegetables (EUR/100 kg) CN code Third country code (1) Standard import value 0702 00 00 IL 181,8 MA 71,9 SY 68,2 TR 101,5 ZZ 105,9 0707 00 05 JO 196,3 MA 52,5 TR 86,6 ZZ 111,8 0709 90 70 JO 149,8 MA 59,6 TR 104,0 ZZ 104,5 0805 10 20 AR 21,9 AU 10,4 BR 25,6 SZ 31,4 TR 51,4 ZA 40,4 ZW 26,4 ZZ 29,6 0805 20 10 MA 77,7 ZZ 77,7 0805 20 30, 0805 20 50, 0805 20 70, CN 61,4 0805 20 90 HR 32,2 IL 66,8 TR 75,3 UY 95,3 ZZ 66,2 0805 50 10 EG 90,7 TR 105,2 ZA 65,9 ZZ 87,3 0808 10 80 AR 79,2 CL 86,0 CN 70,1 MK 33,9 US 77,9 ZA 82,4 ZZ 71,6 0808 20 50 AR 71,4 CN 45,8 TR 145,7 US 107,8 ZZ 92,7 (1) Country nomenclature as fixed by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ZZ’ stands for ‘of other origin’. 11.12.2007EN Official Journal of the European Union L 325/3 COMMISSION REGULATION (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, (3) Under Regulation (EC) No 1896/2000, existing active substances for use in biocidal products had to be identi- fied, and those to be evaluated with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC in one or more product types had to be Having regard to the Treaty establishing the European notified no later than 28 March 2002. Community, (4) Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year Having regard to Directive 98/8/EC of the European Parliament work programme referred to in Article 16(2) of and of the Council of 16 February 1998 concerning the placing Directive 98/8/EC of the European Parliament and of of biocidal products on the market (1), and in particular Article the Council concerning the placing of biocidal products 16(2) thereof, on the market, and amending Regulation (EC) No 1896/2000 (3) established a list of existing active substances. That list covered active substances that had been identified in accordance with Article 3(1) or Article 5(2) of Regulation (EC) No 1896/2000 or in respect of Whereas: which equivalent information had been submitted in a notification in accordance with Article 4(1) of that Regu- lation. (1) Pursuant to Directive 98/8/EC, Member States may only authorise the placing on the market of biocidal products (5) Regulation (EC) No 2032/2003 also established, in containing active substances included in Annex I, IA or Annex II, an exhaustive list of existing active substances IB to that Directive. However, under the transitional to be evaluated under the review programme. That list measures provided for in Article 16(1) of Directive covered active substances in respect of which at least one 98/8/EC Member States may allow the placing on the notification had been accepted in accordance with Article market of biocidal products containing active substances 4(2) of Regulation (EC) No 1896/2000 or in which a not listed in Annex I, IA or IB to Directive 98/8/EC Member State had expressed an interest in accordance which were already on the market on 14 May 2000, with Article 5(3) of that Regulation. That list specified hereinafter ‘existing active substances’. Pursuant to the product types concerned. paragraph 2 of that same Article, a 10-year programme of work is to be carried out for the review of all existing active substances.
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  • August 28,2003 Dockets Management Branch

    August 28,2003 Dockets Management Branch

    Marling Address, PO. Box 997, Akron, Ohio 44309-0997 August 28,2003 Dockets Management Branch Food and Drug Administration (HFA-305) 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Dear Sir/Madam: Attached is a hard copy of the comments that were emailed to you on August 27, 2003 regarding the Proposed Rule; Reopening of the Administrative Record for Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Health-Care Antiseptic Drug Products. 68 Fed. Reg. 32003. (May29, 2003). [Docket No.75N-183H]. Thank you, GOJO INDUSTRIES, INC. Michael J. Dolan Research and Development Vice President c74 www.GOJO.com August 27,2003 Mailrng Address: PO. Box 991, Akron, Ohm 44309-0991 Dockets Management Branch Food and Drug Administration (HFA-305) 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Proposed Rule; Reopening of the Administrative Record for Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Health-Care Antiseptic Drug Products. 68 Fed. Reg. 32003. (May 29,2003). [Docket No. 75N-183H] Dear Sir/Madam: GOJO Industries, Inc. hereby submits these comments in response to the Food and Drug Administration’s (FDA’s) reopening of the administrative record regarding the tentative final monograph for Over-the-Counter (OTC) Health-Care Antiseptic Drug Products, 59 Fed. Reg. 3 1402 (June 17, 1994) (1994 TFM). These comments address the safety and efficacy of benzalkonium chloride and benzethonium chloride as active antimicrobial agents in leave-on products (products used without water and that are not rinsed off the skin). SUMMARY: The anticipated finalization of the 1994 TFM will be accompanied by a review of the safety and efficacy of the quaternary ammonium compounds (quats), benzalkonium chloride and benzethonium chloride.