(1)

Reducing the administrative burden imposed on enterprises by existing Community legislation is a crucial element for improving their competitiveness and for achieving the objectives of the Lisbon agenda.

(2)

Regulation (EC) No 853/2004 lays down specific rules on the hygiene of food of animal origin for food business operators. That Regulation provides that food business operators are to comply with the relevant provisions of Annex III thereto.

(3)

The requirements of Section VIII of Annex III to Regulation (EC) No 853/2004 as regards vessels engaged in primary production and associated operations supplement those laid down in Annex I to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (2). In particular, those vessels are to keep and retain records relating to measures put in place to control hazards in an appropriate manner and for an appropriate period.

(4)

Experience has shown that for food business operators involved in small-scale coastal fishing within the meaning of Article 26 of Council Regulation (EC) No 1198/2006 of 27 July 2006 on the European Fisheries Fund (3), that requirement may create an additional administrative burden. It is therefore appropriate to provide for a derogation from that requirement for such operators.

(5)

Section XIV of Annex III to Regulation (EC) No 853/2004 sets out the requirements for the production of gelatine intended for human consumption. It specifies that when manufactured from ruminant bone material, gelatine must be produced using a unique process that ensures that all bone material is subjected to an alkaline treatment of saturated lime solution (pH > 12,5) for a period of at least 20 days with a heat treatment step of 138 °C minimum during at least four seconds, after having been finely crushed and degreased with hot water and treated with dilute hydrochloric acid (at minimum concentration of 4 % and pH < 1,5) over a period of at least two days.

(6)

The Scientific Panel on Biological Hazards of the European Food Safety Authority adopted on 18 January 2006 an opinion on the ‘Quantitative assessment of the human BSE risk posed by gelatine with respect to residual BSE risk’. On 18 May 2006, it adopted another opinion on the ‘Quantitative assessment of the human BSE risk posed by bovine vertebral column including dorsal root ganglia with respect to residual BSE risk’. According to both opinions, the production processes involving an acid process or a heat and pressure process ensure respectively equivalent and higher BSE infectivity reduction compared to the safety level achieved by applying the alkaline process currently required by Section XIV of Annex III to Regulation (EC) No 853/2004. The conditions for the production of gelatine should therefore be amended accordingly.

(7)

There have been difficulties in interpreting provisions on possible other use of gelatine and collagen produced in accordance with the provisions laid down in Sections XIV and XV of Annex III to Regulation (EC) No 853/2004 in some Member States. It is therefore appropriate to clarify those provisions in order to harmonise their implementation.

(8)

Regulation (EC) No 853/2004 should therefore be amended accordingly.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,