ANNEX
The Annex to Regulation (EC) No 333/2007 is amended as follows:
(1)
point C.2.1. is replaced by the following:
‘C.2.1. Precautions and general considerations
The basic requirement is to obtain a representative and homogeneous laboratory sample without introducing secondary contamination.
The whole part to which the maximum level is applicable shall be used for homogenisation of the sample.
For products other than fish all of the sample material received by the laboratory shall be used for the preparation of the laboratory sample.
For fish, all of the sample material received by the laboratory shall be homogenised. From the homogenised aggregate sample, a representative part/quantity shall be used for the preparation of the laboratory sample.
In case the maximum level applies to the dry matter, the dry matter content of the product shall be determined on a part of the homogenised sample, using a method that has been demonstrated to determine accurately the dry matter content.
Compliance with maximum levels laid down in Regulation (EU) 2023/915 shall be established on the basis of the levels determined in the laboratory samples.’;
(2)
point C.2.2.1. is replaced by the following:
‘C.2.2.1. Specific procedures for lead, cadmium, mercury, inorganic tin, inorganic and total arsenic and nickel
The analyst shall ensure that samples do not become contaminated during sample preparation. Wherever possible, apparatus and equipment coming into contact with the sample shall not contain those metals to be determined and be made of inert materials, e.g. plastics such as polypropylene, polytetrafluoroethylene (PTFE), etc. These shall be acid cleaned to minimise the risk of contamination. High quality stainless steel may be used for cutting edges.
There are many satisfactory specific sample preparation procedures which may be used for the products under consideration. For those aspects not specifically covered by this Regulation, the CEN Standard “Foodstuffs. Determination of elements and their chemical species. General considerations and specific requirements”
( *1 ) has been found to be satisfactory but other sample preparation methods may be equally valid.
In the case of inorganic tin, care shall be taken to ensure that all the material is taken into solution as losses are known to occur readily, particularly because of hydrolysis to insoluble hydrated Sn(IV) oxide species.
In the case of nickel, contamination problems may arise when stainless steel or iron equipment is used for sampling or analysis. Special equipment shall be used in such cases in materials such as titanium, ceramics or agate.
( *1 ) Standard EN 13804:2013, “Foodstuffs. Determination of elements and their chemical species. General considerations and specific requirements”, CEN, Rue de Stassart/Stassartstraat 36, B-1050 Bruxelles/Brussel, BELGIQUE/BELGIË.’;"
(3)
in point C.3.3.1, point (a) is replaced by the following:
‘(a)
Performance criteria for methods of analysis for lead, cadmium, mercury, inorganic tin, inorganic and total arsenic and nickel
Table 5
Parameter
Criterion
Applicability
Foods specified in Regulation (EU) 2023/915
Specificity
Free from matrix or spectral interferences
Repeatability (RSD r )
HORRAT r less than 2
Reproducibility (RSD R )
HORRAT R less than 2
Recovery
The provisions of point D.1.2 apply
LOD
= three tenths of LOQ
LOQ
Inorganic tin
≤ 10 mg/kg
Lead
ML ≤ 0,02 mg/kg
0,02 < ML < 0,1 mg/kg
ML ≥ 0,1 mg/kg
≤ ML
≤ two thirds of the ML
≤ one fifth of the ML
Cadmium, mercury
ML ≤ 0,02 mg/kg
0,02 < ML < 0,1 mg/kg
ML ≥ 0,1 mg/kg
≤ two fifths of the ML
≤ two fifths of the ML
≤ one fifth of the ML
Inorganic arsenic and total arsenic
ML ≤ 0,03 mg/kg
0,03 < ML < 0,1 mg/kg
ML ≥ 0,1 mg/kg
≤ ML
≤ two thirds of the ML
≤ two thirds of the ML
Nickel
ML ≤ 0,3 mg/kg
0,3 < ML < 0,6 mg/kg
ML ≥ 0,6 mg/kg
≤ ML
≤ two thirds of the ML
≤ one third of the ML’
(4)
in point C.3.3.1, point (b), first indent, the references to ‘point 4.1 of the Annex to Regulation (EC) No 1881/2006’ in the title of Table 6a and in Table 6a are replaced by ‘point 5.2 of Annex I to Regulation (EU) 2023/915’;
(5)
in point C.3.3.1, point (b), second indent, the references to ‘point 4.3 of the Annex to Regulation (EC) No 1881/2006’ in the title of Table 6b and in Table 6b is replaced by ‘point 5.3 of Annex I to Regulation (EU) 2023/915’;
(6)
in point C.3.3.1, point (b), third indent:
(a)
the reference to ‘point 4.3 of the Annex to Regulation (EC) No 1881/2006’ in the title of Table 6c and in Table 6c is replaced by ‘point 5.3 of Annex I to Regulation (EU) 2023/915’;
(b)
in the column ‘Parameter’ of Table 6c, the reference to entry ‘4.3.1’ is replaced by ‘5.3.1’, ‘4.3.2’ by ‘5.3.2’, ‘4.3.3’ by ‘5.3.3.1’ and ‘4.3.4’ by ‘5.3.3.2’;
(7)
in point C.3.3.1, point (b), fourth indent:
(a)
the reference to ‘point 4.2 of the Annex to Regulation (EC) No 1881/2006’ in the title of Table 6d and in Table 6d is replaced by ‘point 5.4 of Annex I to Regulation (EU) 2023/915’;
(b)
in the column ‘Parameter’ of Table 6d, the reference to entry ‘4.2.1’ is replaced by ‘5.4.1’, ‘4.2.2’ by ‘5.4.2’, ‘4.2.3’ by ‘5.4.3.1’ and ‘4.2.4’ by ‘5.4.3.2’;
(8)
in point C.3.3.1, point (c), in Table 7 the reference to ‘Regulation (EC) No 1881/2006’ is replaced by ‘Regulation (EU) 2023/915’;
(9)
in point D.1.1. the reference to ‘Regulation (EC) No 1881/2006’ is replaced by ‘Regulation (EU) 2023/915’;
(10)
in point D.2.1. the reference to ‘Regulation (EC) No 1881/2006’ is replaced by ‘Regulation (EU) 2023/915’;
(11)
in point D.2.2. the reference to ‘Regulation (EC) No 1881/2006’ is replaced by ‘Regulation (EU) 2023/915’.
( *1 ) Standard EN 13804:2013, “Foodstuffs. Determination of elements and their chemical species. General considerations and specific requirements”, CEN, Rue de Stassart/Stassartstraat 36, B-1050 Bruxelles/Brussel, BELGIQUE/BELGIË.’;’
