Commission Regulation (EC) No 213/2001
of 9 January 2001
laying down detailed rules for the application of Council Regulation (EC) No 1255/1999 as regards methods for the analysis and quality evaluation of milk and milk products and amending Regulations (EC) No 2771/1999 and (EC) No 2799/1999
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Regulation (EC) No 1255/1999 of 17 May 1999 on the common organisation of the market in milk and milk products(1), and in particular Articles 10 and 15 and Articles 26(3), 29(1) and 31(14) thereof,
Whereas:
(1) Commission Regulations (EEC) No 1216/68 and (EEC) No 3942/92 and (EC) No 86/94, (EC) No 2721/95, (EC) No 1080/96, (EC) No 1081/96, (EC) No 1082/96, (EC) No 1854/96, (EC) No 880/98 and (EC) No 1459/98, the full references of which are given in Annex XXVI to this Regulation, lay down reference and routine methods for the analysis and quality evaluation of milk and milk products and establish the scope and rules for applying those methods. In the interests of clarity and to provide those operating in the sector with a single set of methods and rules for applying them, the abovementioned Regulations should be recast and brought together in a single text. For the same reason, Commission Regulations (EC) No 2771/1999 of 16 December 1999 laying down detailed rules for the application of Council Regulation (EC) No 1255/1999 as regards intervention on the market in butter and cream(2) and (EC) No 2799/1999 of 17 December 1999 laying down detailed rules for applying Regulation (EC) No 1255/1999 as regards the grant of aid for skimmed milk and skimmed-milk powder intended for animal feed and the sale of such skimmed-milk powder(3) should be amended so that the annexes to those Regulations concerning analysis methods can be included in this Regulation.
(2) The composition and quality requirements for milk and milk products laid down under the arrangements provided for in Regulation (EC) No 1255/1999 must be verified to ensure that they are strictly complied with.
(3) The reference methods for such verifications are often methods published by international organisations such as the CEN, IDF, ISO and AOAC International, which are regularly updated by those organisations. In some cases a Community reference method is laid down, while in other cases no reference method is specified in the Community rules. In order to ensure that reference methods are uniformly applied, a list of reference methods should be drawn up each year and only methods included in the list may be applied.
(4) The use of routine methods should not be ruled out. The conditions for using them should therefore be specified.
(5) Common methods should also be established to ensure uniform practice in evaluating the results of analyses, in sensory evaluation of the products concerned and in re-examining results which have been disputed.
(6) For some analyses, there are currently no internationally accepted reference methods which have been validated and thus no information is available on the between-laboratory-variation of analytical results. Community methods should therefore be laid down, which have been validated according to internationally established rules and are applied as reference methods.
(7) Commission Regulation (EC) No 2571/97 of 15 December 1997 on the sale of butter at reduced prices and the granting of aid for cream, butter and concentrated butter for use in the manufacture of pastry products, ice-cream and other foodstuffs(4), as last amended by Regulation (EC) No 635/2000(5), provides for the tracing of cream, butter and concentrated butter in certain circumstances in order to ensure the correct end use of these products. Since tracing is important if the scheme is to function properly, and in order to ensure that operators participating in it receive equal treatment, common methods should be established for determining some of these tracers.
(8) Under Commission Regulation (EEC) No 3143/85 of 11 November 1985 on the sale at reduced prices of intervention butter intended for direct consumption in the form of concentrated butter(6), as last amended by Regulation (EC) No 101/1999(7), Commission Regulation (EEC) No 429/90 of 20 February 1990 on the granting by invitation to tender of an aid for concentrated butter intended for direct consumption in the Community(8), as last amended by Regulation (EC) No 124/1999(9), and Regulation (EC) No 2571/97, concentrated butter must have tracers added to it under supervision. Compliance with the requirements for tracing concentrated butter must be strictly enforced to ensure that products are not diverted. A common method for detecting such tracers should therefore be laid down.
(9) Under Article 9 of Regulation (EC) No 1255/1999, private storage aid may be granted for cheeses made from ewes' milk. A special refund for these same products can be granted under Article 31 of that Regulation. Cheeses made from ewes' milk, goats' milk, buffalos' milk and mixtures of ewes', goats' and buffalos' milk may be imported into the Community under preferential arrangements from certain third countries. In view of the above provisions, appropriate checks are needed to ensure that no cow's milk has been incorporated in the products concerned. A Community reference method should therefore be established for detecting cow's milk, without prejudice to the use of routine methods, provided they comply with certain criteria.
(10) Under Commission Regulation (EEC) No 2921/90 of 10 October 1990 on the granting of an aid for skimmed milk used for the production of casein and caseinates(10), as last amended by Regulation (EC) No 2654/1999(11), the absence of coliforms must be detected. The internationally accepted reference method for detecting coliforms in milk and milk products is International Standard IDF 73A: 1985. However, that standard is applicable only in a modified form for detecting coliforms in a certain quantity of product. A Community reference method for detecting coliforms has therefore been established based on the abovementioned standard.
(11) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff(12), as last amended by Regulation (EC) No 254/2000(13), provides for different rates of customs duty for compound feedingstuffs falling within tariff heading No 2309, depending on their milk-product content. To ensure that the rules in question are uniformly applied, a generally recognised method for analysing lactose content should be laid down for compulsory use in all Member States.
(12) Under Regulation (EC) No 1255/1999, butter and skimmed-milk powder intended for intervention or, in the case of skimmed-milk powder, for use as animal feed, must meet certain quality requirements. Reference methods should be laid down to verify that those requirements are met.
(13) Implementation of some of the methods introduced for the first time in this Regulation will require a period of adaptation. Application of those methods should therefore be deferred.
(14) The Management Committee for Milk and Milk Products has not delivered an opinion within the time limit set by its chairman,
HAS ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Scope and field of application
This Regulation lays down the rules for applying the methods for the chemical, physical and microbiological analysis and sensory evaluation of milk and milk products to be used under the arrangements provided for in the common organisation of the market in milk and milk products established by Regulation (EC) No 1255/1999. It also lays down some of those methods.
Article 2
List of methods
1. Annex I to this Regulation contains the list of reference methods applicable to analyses as referred to in Article 1.
2. The Commission shall update the list at least once a year in accordance with the procedure laid down in Article 42 of Regulation (EC) No 1255/1999.
Article 3
Routine methods
Routine methods may be used for analyses required by the Community rules provided that they are properly calibrated and regularly checked against the reference method.
The procedure described in Annex II may be applied for checking results obtained by routine methods which are close to the limits specified in the Regulations concerned.
In cases of dispute, the results obtained by the reference method shall be decisive.
Article 4
Validation of reference methods
1. Reference methods shall be validated if they meet pre-determined precision criteria concerning the repeatability and reproducibility limit.
2. If a reference method laid down in the Regulations concerned has not been validated, Member States shall set a provisional reproducibility limit.
That limit shall be obtained according to the procedure described in Annex III(b). However, for the first 18 months following the entry into force of this Regulation, the Member States may use an equivalent procedure.
Compliance with the limit shall be checked at least once a year.
3. Where the results of applying validated reference methods or methods with provisional precision figures show that a limit has been exceeded, the analytical results may be evaluated using the method described in Annex IV to determine the critical difference from the limit concerned.
Article 5
Admissibility of analysis results
1. Analyses shall be performed in laboratories operating an internal quality control procedure in accordance with that described in Annex V(a) or a procedure of an equivalent standard.
A detailed description of the procedure applied must be available for consultation in the laboratory.
2. Laboratories shall establish their in-house precision within a run for all methods, following:
(a) the procedure described in Annex V(b), or
(b) a published, validated procedure with an established repeatability.
Compliance with the reproducibility limit must be checked at least once per year using the procedure described in Annex III(a).
The second subparagraph shall not apply to laboratories that have participated in a proficiency testing scheme during the year.
3. Laboratory reports of the results of the analysis must contain sufficient information for an evaluation of the results to be made in accordance with Annex IV and Annex VIII.
4. Analysis results shall be considered admissible if they have been obtained in accordance with the acceptability criteria described in the internal quality control procedure referred to in paragraph 1 and the in-house precision referred to in paragraph 2.
Article 6
Sensory evaluation
1. For butter, the procedures described in Annex VI shall be applied to check the performance of assessors and the reliability of results. The procedure described in Annex VII shall be applied as a reference method for sensory evaluation.
2. For milk and milk products other than butter, the reference method to be used by the Member States for sensory evaluation shall be either IDF standard 99C/1997 or other comparable methods which they shall notify to the Commission.
The procedures described in Annex VI may be used to check the performance of assessors and the reliability of results.
Article 7
Sampling and disputes over the results of analyses
1. Duplicate samples must be taken for analyses required under Community rules.
2. The procedure described in Annex VIII shall be used in cases where the results of an analysis are not accepted by the operator.
CHAPTER II
METHODS OF ANALYSIS
Article 8
Water/solids-non-fat/fat content of butter
1. The analysis method described in Annex IX shall be used as the reference method for determining the water content of butter.
2. The analysis method described in Annex X shall be used as the reference method for determining the solids-non-fat content of butter.
3. The analysis method described in Annex XI shall be used as the reference method for determining the fat content of butter.
Article 9
Tracers
1. The analysis method described in Annex XII shall be used as the reference method for determining vanillin in concentrated butter, butter and cream.
2. The analysis method described in Annex XIII shall be used as the reference method for determining the ethyl ester of beta-apo-8' carotenic acid content of concentrated butter and butter.
3. The analysis method described in Annex XIV shall be used as the reference method for determining the β-sitosterol or stigmasterol content of butter and concentrated butter.
4. Concentrated butter, butter and cream have been traced in conformity with the relevant Community rules if the results obtained are in accordance with the specifications of paragraph 8 of the Annexes referred to in paragraphs 1, 2 and 3.
Article 10
Detection of cows' milk casein
1. The reference method of analysis described in Annex XV shall be used to ensure that cheese which must be made exclusively from ewes' milk, goats' milk or buffalos' milk or from a mixture of ewes', goats' and buffalos' milk does not in fact contain cows' milk casein.
Cows' milk casein shall be held to be present if the apparent cows' milk casein content of the sample to be analysed is equal to or higher than the content of the reference sample containing 1 % cows' milk as described in Annex XV.
2. Routine methods for detecting cows' milk casein in cheeses as referred to in paragraph 1 may be used provided that:
(a) the detection limit is 0,5 % or lower,
(b) there are no false-positive results,
(c) cows' milk casein is detectable with the required sensitivity even after long ripening periods, as may occur in usual commercial conditions.
If the requirement provided for in (b) is not met, any sample giving a positive result must be analysed using the reference method.
If the requirement provided for in (c) is not met for one of the types of cheese referred to in paragraph 1, that cheese must be analysed using the reference method.
Article 11
Detection of coliforms
1. The reference method of analysis described in Annex XVI shall be used to detect the presence of coliforms in butter, skimmed-milk powder, casein and caseinates.
2. Routine methods for detecting coliforms may be used provided that the results obtained are comparable with the results obtained by the reference method described in the said Annex. Routine methods must in particular have an adequate detection limit. False-negative results must not occur. If the occurrence of false-positive results cannot be excluded, any positive result must be confirmed using the reference method.
Article 12
Lactose content
The method for determining the lactose content of products falling within CN code 2309 is described in Annex XVII.
Article 13
Detection of rennet whey
1. The method for detecting rennet whey in skimmed-milk powder intended for public storage is described in Annex XVIII.
2. The method for detecting rennet whey in skimmed-milk powder and mixtures intended for use as animal feed is described in Annex XIX.
Article 14
Detection of buttermilk
The method for detecting buttermilk in skimmed-milk powder is described in Annex XX.
Article 15
Antimicrobiotic residues
The method for detecting antibiotic and sulphonamide/dapson residues in skimmed-milk powder is described in Annex XXI.
Article 16
Skimmed-milk powder content
The method for determining the skimmed-milk powder content in compound feedingstuffs is described in Annex XXII.
Article 17
Detection of starch
The method for detecting starch in skimmed-milk powder, denatured milk powder and compound feedingstuffs is described in Annex XXIII.
Article 18
Moisture content of acid buttermilk powder
The method for determining the moisture content of acid buttermilk powder intended for use in feedingstuffs is described in Annex XXIV.
Article 19
Detection of foreign fats
The method for detecting foreign fats in milk fats is described in Annex XXV.
CHAPTER III
FINAL PROVISIONS
Article 20
Amendments to Regulation (EC) No 2771/1999
Regulation (EC) No 2771/1999 is amended as follows:
1. The first sentence of Article 4(1) is replaced by the following: "The competent authorities shall check the quality of butter using the methods described in Annex I and on the basis of samples taken in accordance with the rules set out in Annex IV."
2. In Annex I, footnote 2 is replaced by the following: "See Annex I to Regulation (EC) No 213/2001".
3. Annexes II and III are deleted.
4. In the penultimate sentence of Annex IV.2, the words "with Annex III" are replaced by "with Annex VII to Regulation (EC) No 213/2001".
Article 21
Amendments to Regulation (EC) No 2799/1999
Regulation (EC) No 2799/1999 is amended as follows:
1. Article 20(1), (2), (3) and (4) is replaced by the following: "1. The skimmed-milk powder content of mixtures and compound feedingstuffs shall be determined by testing each sample at least in duplicate using the analysis method described in Annex XXII to Regulation (EC) No 213/2001, supplemented by the checks provided for in Article 17(3) of this Regulation. Should there be a discrepancy between the results of these checks, the result of the on-the-spot inspection shall be conclusive.
2. The absence of rennet whey shall be proven using the method described in Annex XIX to Regulation (EC) No 213/2001.
3. The starch content of compound feedingstuffs shall be determined by the checks provided for in Article 17(3) of this Regulation, which must be supplemented with the analysis method described in Annex XXIII to Regulation (EC) No 213/2001.
4. The moisture content of acid buttermilk powder shall be determined using the analysis method described in Annex XXIV to Regulation (EC) No 213/2001."
2. Annexes III, IV, V and VI are deleted.
Article 22
Repeals
Regulations (EEC) No 1216/68, (EEC) No 3942/92, (EC) No 86/94, (EC) No 2721/95, (EC) No 1854/96, (EC) No 1080/96, (EC) No 1081/96, (EC) No 1082/96, (EC) No 880/98 and (EC) No 1459/98 are repealed.
References to the repealed Regulations shall be construed as references to this Regulation.
Article 23
Entry into force
This Regulation shall enter into force on the seventh day following its publication in the Official Journal of the European Communities.
However, the methods described in Annexes III, IV.4, V, VI and VIII shall apply 18 months after the entry into force of this Regulation.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 9 January 2001.