COMMISSION REGULATION (EC) No 273/2008
of 5 March 2008
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
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(4) thereof,
Whereas:
(1)
Commission Regulation (EC) No 213/2001 (2) lays 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. In the light of technical developments in the field of analytical methodology further substantial changes need to be made. In the interest of clarity and efficiency and given the number and technical nature of the amendments, Regulation (EC) No 213/2001 should be repealed and replaced by a new regulation.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 European Committee for Standardization (CEN), the International Dairy Federation (IDF), the International Organisation for Standardisation (ISO) and the Scientific Association dedicated to the analytical Excellence (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 and provision should be made for the Commission to adapt the list where necessary.
(4)
The use of routine methods should not be ruled out. Minimal conditions for using them should therefore be specified.
(5)
Common procedures 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 should be applied as reference methods.
(7)
Commission Regulation (EC) No 1898/2005 (3) lays down detailed rules for implementing Council Regulation (EC) No 1255/1999 as regards measures for the disposal of cream, butter and concentrated butter on the Community market and provides for the tracing of cream, butter and concentrated butter in certain circumstances in order to ensure the correct end use of these products. Tracing is important for the proper functioning of the scheme. 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 Article 9 of Regulation (EC) No 1255/1999, private storage aid may be granted for cheeses made from ewes’ milk. A special refund for the 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, 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.
(9)
Under Commission Regulation (EEC) No 2921/90 of 10 October 1990 on aid for the production of casein and caseinates from skimmed milk (4), the absence of coliforms must be detected. The internationally accepted reference methods for detecting coliforms in milk and milk products is ISO 4831. A Community reference method for detecting coliforms has been established based on the abovementioned standard.
(10)
Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (5) 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.
(11)
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.
(12)
Some methods are introduced for the first time in this Regulation. A sufficient period from the time of entry into force of this Regulation should be provided in order to allow laboratories to correctly introduce and use these new methods. Whenever a reference method referred to in Annex I is revised and published by the Standards Developing Organisation, the laboratories should be allowed six months to update their analytical procedures to conform to the new standard.
(13)
The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Milk and Milk products,
HAS ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter and scope
1. This Regulation lays down certain reference 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 and the rules for applying those methods.
2. The list of the reference methods applicable to analyses as referred to in paragraph 1 is laid down in Annex I to this Regulation.
3. The Commission shall update the list in accordance with the procedure laid down in Article 42 of Regulation (EC) No 1255/1999.
Article 2
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. Results shall be compared taking into account the constant bias, the repeatability and the reproducibility.
In cases of dispute, the result obtained by the reference method shall be decisive.
Member States shall inform the Commission on the use of routine methods in the analysis referred to in Article 1.
CHAPTER II
METHODS OF ANALYSIS
Article 3
Evaluation of compliance of a consignment with a legal limit
Except for the analysis of tracers, Annex II to this Regulation shall apply in order to define compliance with legal compositional requirements.
Article 4
Sensory evaluation
1. For milk and milk products other than butter for public storage, 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 III shall be applied to check the performance of assessors and the reliability of results in sensory analyses.
2. For butter for public storage, the procedures described in Annex III shall be applied to check the performance of assessors and the reliability of results in sensory analyses.
The procedure laid down in Annex IV shall be applied as a reference method for sensory evaluation.
Article 5
Tracers
1. The method of analysis laid down in Annex V shall be used as the reference method for determining the content of enanthic acid triglyceride in butter, butter-oil and cream.
2. The method of analysis laid down in Annex VI shall be used as the reference method for determining vanillin in concentrated butter, butter and cream.
3. The method of analysis laid down in Annex VII shall be used as the reference method for determining the ethyl ester of beta-apo-8' carotenic acid content of concentrated butter and butter.
4. The analysis method laid down in Annex VIII shall be used as the reference method for determining the β-sitosterol or stigmasterol content of butter and concentrated butter.
5. Concentrated butter, butter and cream are considered to be traced in conformity with the relevant Community rules if the results obtained are in accordance with the specifications of points 10 and 11 of Annex V and point 8 of Annexes VI, VII and VIII.
Article 6
Detection of cows’ milk casein
1. The reference method of analysis laid down in Annex IX shall be used to ensure that cheese made exclusively from ewes’ milk, goats’ milk or buffalos’ milk or from a mixture of ewes’, goats’ and buffalos’ milk does not contain cows’ milk casein.
Cows’ milk casein is considered to be present if the cows’ milk casein content of the analysed sample is equal to or higher than the content of the reference sample containing 1 % cows’ milk as laid down in Annex IX.
2. Routine methods for detecting cows’ milk casein in cheeses referred to in paragraph 1 may be used provided that:
(a)
the detection limit is maximum 0,5 %; and
(b)
there are no false-positive results; and
(c)
cows’ milk casein is detectable with the required sensitivity even after long ripening periods, as may occur in usual commercial conditions.
If any of the above mentioned requirements is not met, the reference methods laid down in Annex IX shall be used.
Article 7
Detection of coliforms
Coliforms in butter, skimmed-milk powder, casein and caseinates shall be detected in accordance with the reference method laid down in Annex X.
Article 8
Determination of the lactose content
The lactose content of products falling within CN code 2309 shall be determined in accordance with the reference method laid down in Annex XI.
Article 9
Detection of rennet whey
1. Rennet whey in skimmed-milk powder intended for public storage shall be detected in accordance with the reference method laid down in Annex XII.
2. Rennet whey in skimmed-milk powder and mixtures intended for use as animal feed shall be detected in accordance with the reference method laid down in Annex XII. In case of detection of rennet whey, Annex XIII should be implemented.
Article 10
Detection of buttermilk
Buttermilk in skimmed-milk powder shall be detected in accordance with the reference method laid down in Annex XIV.
Article 11
Detection of antimicrobiotic residues
Antimicrobial residues in skimmed-milk powder shall be detected in accordance with the reference method laid down in Annex XV.
Article 12
Determination of skimmed-milk powder content
Skimmed-milk powder content in compound feedingstuffs shall be determined in accordance with the reference method laid down in Annex XVI.
Article 13
Detection of starch
Starch in skimmed-milk powder, denatured milk powder and compound feedingstuffs shall be detected in accordance with the reference method laid down in Annex XVII.
Article 14
Determination of moisture content in dried cream
Moisture content in dried cream shall be determined in accordance with the reference method laid down in Annex XVIII.
Article 15
Determination of moisture content of acid buttermilk powder
Moisture content in acid buttermilk powder intended for use in feedingstuffs shall be determined in accordance with the reference method laid down in Annex XIX.
Article 16
Determination of milk fat purity
Milk fat purity shall be determined in accordance with the reference method laid down in Annex XX.
CHAPTER III
GENERAL AND FINAL PROVISIONS
Article 17
Quality assurance
Analyses shall be performed in laboratories having an analytical quality assurance system including internal quality control procedures. Not accredited laboratories shall participate in proficiency testing schemes at least once per year and their results shall not deviate by more than 2σR (reproducibility standard deviation of the reference method) from the consensus value. A detailed description of the systems used shall be available for consultation in the laboratory.
Laboratories that are accredited in accordance with the standards referred to in Article 12 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (6) shall be exempted from the obligation to participate in proficiency testing.
Article 18
Sampling and disputes over the results of analysis
1. Sampling shall be carried out in accordance with the relevant regulation for the product under consideration. If no sampling provisions are presented, then the provision given in ISO 707 | IDF 50, Milk and milk products - Guidance of sampling, shall be used.
2. 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 II and Annex XXI.
3. Duplicate samples must be taken for analyses required under Community rules.
4. The procedure described in Annex XXI shall be used in cases where the results of an analysis are not accepted by the operator.
5. If the manufacturer can prove, within five working days of sampling, that the sampling procedure was not carried out correctly, sampling must be repeated where possible. If sampling cannot be repeated, the consignment must be accepted.
Article 19
Transition period
Evaluation of compliance according to Annex II to this Regulation shall be performed within 12 months after its entry into force. Member States will immediately report to the Commission where necessary if any major problem is encountered during this period with the statistical control procedure.
Article 20
Repeals
Regulation (EC) No 213/2001 is repealed.
References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex XXII.
Article 21
Entry into force
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
It shall apply from 31 March 2008.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 March 2008.