Act concerning the conditions of accession of the Republic of Bulgaria and Romania and the adjustments to the Treaties on which the European Union is founded - Annex VI:List referred to in Article 23 of the Act of Accession: transitional measures, Bulgaria - 4.Agriculture - B.Veterinary and phytosanitary legislation
Official Journal L 157 , 21/06/2005 P. 0283 - 0284
B. VETERINARY AND PHYTOSANITARY LEGISLATION
32004 R 0853: 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 (OJ L 139, 30.4.2004, p. 55).
(a) The milk processing establishments listed in Chapters I and II of the Appendix to this Annex may until 31 December 2009 receive deliveries of raw milk that does not comply with or has not been handled in accordance with the requirements in Regulation (EC) No 853/2004, Annex III, Section IX, Chapter I, subchapters II and III provided that those farms from which the milk is delivered are mentioned on a list maintained for that purpose by the Bulgarian authorities.
(b) As long as the establishments referred to in paragraph (a) above benefit from the provisions of that paragraph, products originating from those establishments shall only be placed on the domestic market or used for further processing in establishments in Bulgaria also covered by the provisions of paragraph (a), irrespective of the date of marketing. These products must bear a different identification mark to that provided for in Article 5 of Regulation (EC) No 853/2004.
(c) The establishments listed in Chapter II of the Appendix to this Annex may until 31 December 2009 process EU compliant and EU non-compliant milk on separate production lines. In this context EU non-compliant milk is understood as the milk referred to in paragraph (a). Such establishments must fully comply with the EU requirements for establishments, including the implementation of the Hazard Analysis and Critical Control Point (HACCP) principles (referred to in Article 5 of Regulation (EC) No 852/2004  and must demonstrate their capacity to fully comply with the following conditions, including designating their relevant production lines:
- take all necessary measures to allow for the proper observance of in-house procedures for the separation of milk starting from collection up to the final product stage, including routes of milk collection, separate storage and treatment of EU compliant and non‐compliant milk, specific packaging and labelling of products based on EU non‐compliant milk as well as separate storage of such products,
- establish a procedure ensuring raw material traceability, including the necessary documentary evidence of product movements and the accountancy for products and reconciliation of compliant and non-compliant raw materials with the categories of products produced,
- expose all raw milk to heat treatment at a temperature of minimum 71,7 oC for 15 seconds, and
- take all appropriate measures to ensure that the identification marks are not used fraudulently.
The Bulgarian authorities shall:
- ensure that the operator or manager of each establishment concerned takes all necessary measures to allow for the proper observance of in-house procedures for the separation of milk;
- conduct tests and unannounced controls relating to the observance of milk separation; and
- conduct tests in approved laboratories on all raw and finished products to verify their compliance with the requirements of Regulation (EC) No 853/2004, Annex III, Section IX, Chapter II, including the microbiological criteria for milk-based products.
The milk and/or milk-based products originating from separate production lines processing EU non-compliant raw milk in EU-approved milk processing establishments may only be placed on the market subject to the conditions laid down in paragraph (b). Products based on compliant raw milk processed on a separate production line in an establishment listed in Chapter II of the Appendix to this Annex can be marketed as compliant products as long as all conditions regarding separation of product lines are maintained.
(d) Milk and milk products produced under the provisions referred to in paragraph (c) shall only be granted support under Title I, Chapters II and III, except Article 11 thereof, and Title II of Regulation (EC) No 1255/1999  if they carry the oval identification mark referred to in Annex II, Section I of Regulation (EC) No 853/2004.
(e) Bulgaria shall ensure gradual compliance with the requirements referred to in paragraph (a) and shall submit annual reports to the Commission on progress made in upgrading dairy farms and the milk collection system. Bulgaria shall ensure that these requirements are fully complied with by 31 December 2009.
(f) The Commission may, in accordance with the procedure referred to in Article 58 of Regulation (EC) No 178/2002 , update the Appendix to this Annex before accession and until 31 December 2009 and in this context add or delete individual establishments in the light of progress made in the correction of existing shortcomings and the outcome of the monitoring process.
Detailed implementation rules to ensure the smooth operation of the above transitional regime may be adopted in accordance with the procedure referred to in Article 58 of Regulation (EC) No 178/2002.
 Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).
 Council Regulation (EC) No 1255/1999 of 17 May 1999 on the common organisation of the market in milk and milk products (OJ L 160, 26.6.1999, p. 48), Regulation as last amended by Commission Regulation (EC) No 186/2004 (OJ L 29, 3.2.2004, p. 6).
 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). Regulation as last amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).