TITLE IIOFFICIAL CONTROLS AND OTHER OFFICIAL ACTIVITIES ...

CHAPTER IIOfficial controls

Section IIAdditional requirements for official controls and other official activities in certain areas

Article 16Additional requirements

1.

In the areas governed by the rules provided for in this Section, those rules shall apply in addition to the other rules set out in this Regulation.

2.

When F1making regulations provided for in this Section, the appropriate authority shall take into account the following:

(a)

the experience gained by competent authorities and food and feed business operators when applying the procedures referred to in Article 5 of Regulation (EC) No 852/2004 of the European Parliament and of the Council52 and Article 6 of Regulation (EC) No 183/2005 of the European Parliament and of the Council53;

(b)

scientific and technological developments;

(c)

consumer expectations with regard to food composition and changes in patterns of consumption of food;

(d)

risks to human and animal health and plant health associated with animals and goods; and

(e)

information on possible intentional violations perpetrated through fraudulent or deceptive practices.

3.

When F2making regulations provided for in this Section, and insofar as this does not prevent the achievement of the objectives pursued by the rules referred to in Article 1(2), the F3appropriate authority shall also take into account the following:

(a)

the need to facilitate the application of the F4regulations, taking into account the nature and the size of small businesses;

(b)

the need to enable the continued use of traditional methods at any stage of production, processing or distribution of food, and the production of traditional foods; and

(c)

the needs of operators situated in regions that are subject to specific geographical constraints.