7.6.2005

Official Journal of the European Union

L 143/3

COMMISSION REGULATION (EC) No 856/2005

of 6 June 2005

amending Regulation (EC) No 466/2001 as regards Fusarium toxins

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (1), and in particular Article 2(3) thereof,

Whereas:

(1)	Commission Regulation (EC) No 466/2001 (2) provides for maximum levels for certain contaminants in foodstuffs.

(2)

Certain Member States have adopted or plan to adopt maximum levels for Fusarium toxins, such as deoxynivalenol (DON), zearalenone (ZEA) and fumonisins in certain foodstuffs. In view of the disparities between the level authorised in Member States and the consequent risk of distortion of competition, Community measures are necessary in order to ensure market unity while complying with the principle of proportionality.

(3)

A variety of Fusarium fungi, which are common soil fungi, produce a number of different mycotoxins of the class of trichothecenes such as deoxynivalenol (DON), nivalenol (NIV), T-2 toxin and HT-2 toxin and some other toxins (zearalenone and fumonisins). The Fusarium fungi are commonly found on cereals grown in the temperate regions of America, Europe and Asia. Several of the toxin producing Fusarium fungi are capable of producing to a variable degree two or more of these toxins.

(4)

The Scientific Committee for Food (SCF) has evaluated in a set of opinions the Fusarium toxins: deoxynivalenol (DON) in December 1999, zearalenone in June 2000, fumonisins in October 2000, updated in April 2003, nivalenol in October 2000 and T-2 and HT-2 toxin in May 2001 and a group evaluation of the trichothecenes in February 2002.

(5)

The SCF considered that the available data did not support the establishing of group Tolerable Daily Intake (TDI) for the evaluated trichothecenes and established

—	a TDI of 1 μg/kg body weight/day for deoxynivalenol (DON),

—	a temporary TDI (t-TDI) of 0,7 μg/kg body weight/day for nivalenol,

—	a combined temporary TDI of 0,06 μg/kg body weight/day for T-2 and HT-2 toxin.

For the other Fusarium toxins the SCF established

—	a temporary TDI (t-TDI) of 0,2 μg/kg body weight/day for zearalenone,

—	a TDI of 2 μg/kg bodyweight/day for the total of fumonisin B1, B2 and B3, alone or in combination.

(6)

In the framework of Council Directive 93/5/EEC of 25 February 1993 on assistance to the Commission and cooperation by the Member States in the scientific examination of questions relating to food (3), a scientific cooperation (SCOOP) task 3.2.10 ‘Collection of occurrence data on Fusarium toxins in food and assessment of dietary intake by the population of EU Member States’ (4) was performed and finalised in September 2003.

The results of that task demonstrate that Fusarium mycotoxins are widely distributed in the food chain in the Community. The major sources of dietary intake of Fusarium toxins are products made from cereals, in particular wheat and corn. While the dietary intakes of Fusarium toxins for the entire population and adults are often less than the TDI’s for the respective toxin, for risk groups like infants and young children, they are close or even exceed the TDI in some cases.

(7)

In particular for deoxynivalenol, the dietary intake for the group of young children and adolescents is close to the TDI. For T-2 and HT-2 toxin, the estimated dietary intake exceeded in most of the cases the t-TDI. However, it has to be noted that for T-2 and HT-2 toxin most occurrence data were obtained by making use of methods of analysis with a high limit of detection and taking into consideration that the amount of samples above the limit of detection was lower than 20 %, the dietary intake was strongly influenced by the limit of detection of the used analytical methods. For nivalenol all intakes were far below the t-TDI. As regards the other trichothecenes considered in the abovementioned SCOOP-Task, such as 3-acetyldeoxynivalenol, 15-acetyldeoxynivalenol, fusarenon-X, T2-triol, diacetoxyscirpenol, neosolaniol, monoacetoxyscirpenol and verrucol, as far as the information is available all dietary intakes are low.

(8)

For zearalenone, the average daily intake is significantly lower than the TDI but attention should be paid to population groups not identified in the task which might have regularly high consumption of products with high incidence of zearalenone contamination and to food aimed for consumption among children, since the diversity of the diet is among young children is limited.

(9)

For fumonisins, the estimated dietary intake for most population groups is far below the TDI. The dietary intake of fumonisins increases significantly when consumers only are considered. Nevertheless, the dietary intake is also for that group of consumers below the TDI. However, monitoring control results of the harvest 2003 indicate that maize and maize products can be very highly contaminated by fumonisins. It is appropriate that measures are taken to avoid that such unacceptably highly contaminated maize and maize products can enter the food chain.

(10)

Fusarium species infect the grain pre-harvest. In connection with Fusarium infection and Mycotoxin formation several risk factors have been identified. Climatic conditions during the growth, in particular at flowering, have a major influence on the mycotoxin content. However, good agricultural practices, whereby the risk factors are reduced to a minimum, can prevent to a certain degree the contamination by Fusarium fungi.

(11)

It is important for the protection of public health that maximum levels are set on unprocessed cereals in order to avoid that highly contaminated cereals can enter the food chain and to encourage and ensure that all measures are taken during the field, harvest and storage stage of the production chain (by applying good agricultural, harvest and storage practices). It is appropriate to apply the maximum level on unprocessed cereals to cereals placed on the market for first stage processing as the intended use (for food, feed or industrial) of the cereals is known at this stage. Cleaning, sorting, drying procedures are not considered as first-stage processing insofar no physical action is exerted on the grain kernel itself while scouring is to be considered as first-stage processing.

(12)

Maximum levels are set at a level taking into account the current human exposure in relation with the tolerable intake of the toxin in question and which can be reasonably achieved by following good practices at all stages of production and distribution. Such an approach ensures that food business operators apply all possible measures to prevent/reduce the contamination as far as possible in order to protect public health.

(13)

For maize, not all factors involved in the formation of Fusarium toxins, in particular zearalenone and fumonisins B1 and B2 are yet precisely known. Therefore, a time period is granted to enable food business operators in the cereal chain to perform investigations on the sources of the formation of these mycotoxins and on the identification of the management measures to be taken to prevent their presence as much as reasonably possible. Maximum levels based currently available occurrence data are proposed to apply from 2007 in case no specific maximum levels based on new information on occurrence and formation are set before that time.

(14)

Through cleaning and processing the content of Fusarium toxins in raw cereals can be reduced at a varying degree in processed cereal products. Given the varying degree of reduction, it is appropriate to set a maximum level for final consumer cereal products to protect the consumer and necessary to have an enforceable legislation. In setting maximum levels for final consumer cereal products, a pragmatic approach has to be followed. Furthermore the setting of a maximum level for major food ingredients derived from cereals is appropriate in order to ensure an efficient enforcement in the interest of ensuring public health protection.

(15)	Given the low contamination levels of Fusarium toxins found in rice, no maximum levels are proposed for rice or rice products.

(16)

It is not necessary due to co-occurrence to consider specific measures for 3-acetyl deoxynivalenol, 15-acetyl deoxynivalenol and Fumonisin B3, as possible measures with regard to in particular deoxynivalenol and Fumonisin B1 + B2 would also protect the human population from an unacceptable exposure from 3-acetyl deoxynivalenol, 15-acetyl deoxynivalenol and Fumonisin B3. The same applies to nivalenol for which to a certain degree co-occurrence with deoxynivalenol can be observed and human exposure to nivalenol is estimated to be significantly below the t-TDI.

(17)

Data on the presence of T-2 and HT-2 toxin are for the time being limited. There is also an urgent need for the development and validation of a sensitive method of analysis. However intake estimates indicate clearly that the presence of T-2 and HT-2 can be of concern for public health. Therefore, the development of a sensitive method, collection of more occurrence data and more investigations/research in the factors involved in the presence of T-2 and HT-2 in cereal and cereal products, in particular in oats and oat products, is necessary and of high priority.

(18)	Regulation (EC) No 466/2001 should therefore be amended accordingly.

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

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 466/2001 is amended as follows:

(1)

In Article 2, paragraph 3 is replaced by the following:

‘3. Without prejudice to Articles 3(1) and 4(3), the following shall be prohibited

(a)	to use products, which do not comply with the maximum levels set out in Annex I, as food ingredients for the production of compound or other foodstuffs;

(b)	to mix products complying with the maximum levels with products exceeding the maximum levels set out in Annex I;

(c)	to deliberately detoxify products by chemical treatments in the case of contaminants listed in section 2 (Mycotoxins) of Annex I.’

(2)

In Article 5, the following paragraph 5 is added:

‘5. The Commission shall review points 2.4, 2.5, 2.6 and 2.7 of section 2 of Annex I by 1 July 2008 as regards the maximum limits for deoxynivalenol, zearalenone and fumonisin B1+B2 and with a view to including a maximum level for T-2 and HT-2 toxin in cereals and cereal products.

For that purpose, the Member States and interested parties shall communicate each year to the Commission the results of investigations undertaken including occurrence data and the progress with regard to the application of prevention measures to avoid contamination by deoxynivalenol, zearalenone, T-2 and HT-2 toxin and fumonisin B1+B2.’

(3)	Annex I is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 July 2006. This Regulation shall not apply to products which were placed on the market before 1 July 2006 in conformity with the provisions applicable. The burden of proving when the products were placed on the market shall be borne by the food business operator.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 6 June 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission

(1) OJ L 37, 13.2.1993, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

(2) OJ L 77, 16.3.2001, p. 1. Regulation as last amended by Regulation (EC) 208/2005 (OJ L 34, 8.2.2005, p. 3).

(3) OJ L 52, 4.3.1993, p. 18. Directive as amended by Regulation (EC) No 1882/2003.

(4) Report available on the website of the European Commission, DG Health and Consumer Protection (http://europa.eu.int/comm/food/fs/scoop/task3210.pdf).

ANNEX

In Section 2 Mycotoxins of Annex I to Regulation (EC) No 466/2001, the following points 2.4, 2.5, 2.6, and 2.7 are added:

‘Product (1)

Maximum level

(μg/kg)

Sampling method

Reference analysis method

2.4.

DEOXYNIVALENOL (DON)

2.4.1.

Unprocessed cereals (2) other than durum wheat, oats and maize

1 250

Directive 2005/38/EC (*1)

Directive 2005/38/EC

2.4.2.

Unprocessed durum wheat and oats

1 750

Directive 2005/38/EC

2.4.3.

Unprocessed maize

— (3)

Directive 2005/38/EC

2.4.4.

Cereal flour, including maize flour, maize grits ands maize meal (4)

750

Directive 2005/38/EC

2.4.5.

Bread, pastries, biscuits, cereal snacks and breakfast cereals

500

Directive 2005/38/EC

2.4.6.

Pasta (dry)

750

Directive 2005/38/EC

2.4.7.

Processed cereal-based food for infants and young children and baby food (5)

200

Directive 2005/38/EC

Product (6)

Maximum level

(μg/kg)

Sampling method

Reference analysis method

2.5.

ZEARALENONE

2.5.1.

Unprocessed cereals (7) other than maize

100

Directive 2005/38/EC

2.5.2.

Unprocessed maize

— (8)

Directive 2005/38/EC

2.5.3.

Cereal flour except maize flour

Directive 2005/38/EC

2.5.4.

Maize flour, maize meal, maize grits and refined maize oil (9)

— (8)

Directive 2005/38/EC

2.5.5.

— Bread, pastries, biscuits

Directive 2005/38/EC

— maize snacks and maize-based breakfast cereals

— (8)

— other cereal snacks and breakfast cereals

2.5.6. —

processed maize-based foods for infants and young children

— (8)

Directive 2005/38/EC

—	other processed cereal-based foods for infants and young children and baby food (10)

Product

Maximum level FB1 + FB2

(μg/kg)

Sampling method

Reference analysis method

2.6.

FUMONISINS (11)

2.6.1.

Unprocessed maize (12)

— (13)

Directive 2005/38/EC

2.6.2.

Maize grits, maize meal and maize flour (14)

— (13)

Directive 2005/38/EC

2.6.3.

Maize-based foods for direct consumption with the exception of 2.6.2 and 2.6.4

— (13)

Directive 2005/38/EC

2.6.4.

Processed maize-based foods for infants and young children and baby food (15)

— (13)

Directive 2005/38/EC

Product (17)

Maximum level

(μg/kg)

Sampling method

Reference analysis method

2.7.

T-2 AND HT-2 TOXIN (16)

2.7.1.

Unprocessed cereals (18) and cereal products

— (19)

Directive 2005/38/EC

(*1) See page 18 of this Official Journal.

(1) For the purpose of the application of maximum levels of deoxynivalenol, zearalenone, fumonisins B1 and B2, T-2 and HT-2 toxin established in points 2.4, 2.5, 2.6 and 2.7 only, rice is not included in “cereals” and rice products not included in “cereal products.”

(2) The maximum levels set for “unprocessed cereals” applies to cereals placed on the market for first-stage processing. However, the maximum levels do apply for the cereals harvested and taken over, as from the 2005/2006 marketing year, in accordance with Commission Regulation (EC) No 824/2000 of 19 April 2000 establishing procedures for the taking-over of cereals by intervention agencies and laying down methods of analysis for determining the quality of cereals (OJ L 100, 20.4.2000, p. 31), as last amended by Regulation (EC) No 777/2004 (OJ L 123, 27.4.2004, p. 50).

“First-stage processing” shall mean any physical or thermal treatment, other than drying, of or on the grain.

Cleaning, sorting and drying procedures are not considered to be “first stage processing” insofar as no physical action is exerted on the grain kernel itself and the whole grain remains intact after cleaning and sorting.

(3) If no specific level is fixed before 1 July 2007, the level of 1 750 μg/kg will apply thereafter to maize referred to in this point.

(4) This category includes also similar products otherwise denominated such as semolina.

(5) Processed cereal-based foods for infants and young children and baby food as defined in Article 1 of Commission Directive 96/5/EC of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children (OJ L 49, 28.2.1996, p. 17) as last amended by Directive 2003/13/EC (OJ L 41, 14.2.2003, p. 33).

The maximum level for processed cereal-based foods for infants and young children and baby food refers to the dry matter.

(6) For the purpose of the application of maximum levels of deoxynivalenol, zearalenone, fumonisins B1 and B2, T-2 and HT-2 toxin established in points 2.4, 2.5, 2.6 and 2.7 only, rice is not included in “cereals” and rice products not included in “cereal products.”

(7) The maximum levels set for “unprocessed cereals” applies to cereals placed on the market for first-stage processing. However, the maximum levels do apply for the cereals harvested and taken over, as from the 2005/2006 marketing year, in accordance with Commission Regulation (EC) No 824/2000 establishing procedures for the taking over of cereals by intervention agencies and laying down methods of analysis for determining the quality of cereals (OJ L 100, 20.4.2000, p. 31), as last amended by Regulation (EC) No 777/2004 (OJ L 123, 27.4.2004, p. 50).

“First-stage processing” shall mean any physical or thermal treatment, other than drying, of or on the grain.

Cleaning, sorting and drying procedures are not considered to be “first-stage processing” insofar no physical action is exerted on the grain kernel itself and the whole grain remains intact after cleaning and sorting.

(8) If no specific level is fixed before 1 July 2007, the level of

—	200 μg/kg will apply thereafter to unprocessed maize

—	200 μg/kg will apply thereafter to maize flour, maize meal, maize grits and refined maize oil

—	50 μg/kg will apply thereafter to maize snacks and maize-based breakfast cereals

—	20 μg/kg will apply thereafter to processed maize-based foods for infants and young children.

(9) This category includes also similar products otherwise denominated such as semolina.

(10) Processed cereal-based foods for infants and young children and baby food as defined in Article 1 of Commission Directive 96/5/EC of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children (OJ L 49, 28.2.1996, p. 17) as last amended by Directive 2003/13/EC (OJ L 41, 14.2.2003, p. 33).

The maximum level for processed cereal-based foods for infants and young children and baby food refers to the dry matter.

(11) The maximum level applies to the sum of Fumonisin B1 (FB1) and Fumonisin B2 (FB2).

(12) The maximum level set for “unprocessed maize” applies to maize placed on the market for first-stage processing. However, the maximum levels do apply for the maize harvested and taken over, as from the 2006/2007 marketing year, in accordance with Commission Regulation (EC) No 824/2000 establishing procedures for the taking over of cereals by intervention agencies and laying down methods of analysis for determining the quality of cereals (OJ L 100, 20.4.2000, p. 31), as last amended by Regulation (EC) No 777/2004 (OJ L 123, 27.4.2004, p. 50).

“First-stage processing” shall mean any physical or thermal treatment, other than drying, of or on the grain.

(13) If no specific level is fixed before 1 October 2007, the level of

—	2 000 μg/kg will apply thereafter to unprocessed maize

—	1 000 μg/kg will apply thereafter to maize flour, maize meal, maize grits and refined maize semolina

—	400 μg/kg will apply thereafter to maize based foods for direct consumption

—	200 μg/kg will apply thereafter to processed maize based foods for infants and young children and baby food.

(14) This category includes also similar products otherwise denominated such as semolina.

(15) Processed cereal-based foods for infants and young children and baby food as defined in Article 1 of Commission Directive 96/5/EC of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children (OJ L 49, 28.2.1996, p. 17) as last amended by Directive 2003/13/EC (OJ L 41, 14.2.2003, p. 33).

The maximum level for processed cereal-based foods and baby food for infants and young children refers to the dry matter.

(16) The maximum level refers to the sum of T-2 and HT-2 toxin.

(17) For the purpose of the application of maximum levels of deoxynivalenol, zearalenone, fumonisins B1 and B2, T-2 and HT-2 toxin established in points 2.4, 2.5, 2.6 and 2.7 only, rice is not included in “cereals” and rice products not included in “cereal products”.

(18) The maximum levels set for “unprocessed cereals” applies to cereals placed on the market for first-stage processing.

“First-stage processing” shall mean any physical or thermal treatment, other than drying, of or on the grain. Cleaning, sorting and drying procedures are not considered to be “first stage processing” insofar as no physical action is exerted on the grain kernel itself and the whole grain remains intact after cleaning and sorting.

(19) A maximum level will be fixed, if appropriate, before 1 July 2007.

Data on the presence of T-2 and HT-2 toxin are for the time being limited. However, intake estimates indicate clearly that the presence of T-2 and HT-2 can be of concern for public health. Therefore, the development of a sensitive method, collection of more occurrence data and more investigations/research in the factors involved in the presence of T-2 and HT-2 in cereal and cereal products particularly in oats and oat products is necessary and of high priority.’

7.6.2005

Official Journal of the European Union

L 143/11

COMMISSION REGULATION (EC) No 858/2005

of 6 June 2005

accepting undertakings offered in connection with the anti-dumping proceeding concerning imports of potassium chloride originating in the Republic of Belarus or the Russian Federation and making imports of potassium chloride originating in the Republic of Belarus and the Russian Federation subject to registration

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 384/96 of 22 December 1995 on protection against dumped imports from countries not members of the European Community (1) (the basic Regulation) and in particular Articles 8, 21 and 22(c) thereof,

Having regard to Council Regulation (EC) No 992/2004 of 17 May 2004 amending Regulation (EEC) No 3068/92 imposing a definitive anti-dumping duty on imports of potassium chloride originating in Belarus, Russia or Ukraine (2),

Having regard to Commission Regulation (EC) No 1002/2004 of 18 May 2004 accepting undertakings offered in connection with the anti-dumping proceeding concerning imports of potassium chloride originating in Belarus, Russia or Ukraine and making imports of potassium chloride in Belarus or Russia subject to registration (3),

After consulting the Advisory Committee,

Whereas:

A. PROCEDURE

(1)

The Council, by Regulation (EEC) No 3068/92 (4), imposed a definitive anti-dumping duty (the measures) on imports of potassium chloride (potash) originating in the Republic of Belarus (Belarus) and the Russian Federation (Russia) and Ukraine. By Regulation (EC) No 969/2000 (5), the Council amended Regulation (EEC) No 3068/92.

(2)

In March 2004, by means of a notice published in the Official Journal of the European Union (6), the Commission launched, on its own initiative, a partial interim review of the measures in force on imports of potash originating in Belarus and Russia in order to examine whether they should be amended to take account of the enlargement of the European Union to 25 Member States on 1 May 2004 (enlargement).

(3)

The results of that partial interim review showed that it was in the interests of the Community to provide for the temporary adaptation of the measures so as to avoid a sudden and excessively negative economic impact immediately following enlargement on importers and users in the 10 new Member States (EU-10) which acceded to the European Union on enlargement.

(4)

In this regard, the Council, by Regulation (EC) No 992/2004, authorised the Commission to accept undertaking offers respecting the conditions set out in recitals 27 to 32 of the same Regulation. On this basis, and pursuant to Articles 8, 11(3), 21 and 22(c) of the basic Regulation, the Commission, by Regulation (EC) No 1002/2004 accepted undertaking offers (special Enlargement Undertakings) from (i) an exporting producer in Belarus jointly with companies situated in Austria, Lithuania and Russia, (ii) from an exporting producer in Russia jointly with companies situated in Russia and Austria, and (iii) from an exporting producer in Russia jointly with a company situated at the time of acceptance in Cyprus.

(5)	In addition, in order to provide for the exemption from the anti-dumping duties imposed by Regulation (EEC) No 3068/92 on imports into the EU-10 made under the terms of the special Enlargement Undertakings, Regulation (EEC) No 3068/92 was amended by Regulation (EC) No 992/2004.

(6)

In April 2004, by means of two notices published in the Official Journal of the European Union (7), pursuant to Article 11(3) of the basic Regulation, the Commission launched at the request of the two Russian exporting producers with special Enlargement Undertakings partial interim reviews of the anti-dumping measures applicable to the companies concerned (partial interim reviews for Russia).

(7)

In April 2005, by means of a notice published in the Official Journal of the European Union (8), pursuant to Article 11(2) of the basic Regulation, the Commission launched at the request of the Community Industry for potash an expiry review of the anti-dumping measures applicable to Russia (expiry review for Russia) and to Belarus (expiry review for Belarus).

(8)

In parallel, by means of a notice published in the Official Journal of the European Union (9), pursuant to Article 11(3) of the basic Regulation, the Commission launched at the request of the exporting producer in Belarus a review of the anti-dumping measures applicable to it (partial interim review for Belarus).

(9)	Offers of new special Enlargement Undertakings for a further temporary period have been made by the companies concerned.

B. DURATION OF THE MEASURES

(10)

It should be recalled that acceptance of the undertakings in question was an exceptional measure adopted pursuant to Article 22(c) of the basic Regulation as the Minimum Import Prices (MIPs) established (and to be respected by the companies concerned) were not directly equivalent to the anti-dumping duty.

(11)

In this regard, the MIPs were set at levels which were higher than previous import prices from the countries concerned, but below prices which totally eliminated the injurious effects of dumping, as would normally be the case. It was intended that these MIPs, applied over a transitional period, would help lessen the economic impact of the anti-dumping measures for importers and particularly end users in the EU-10 during the period following enlargement.

(12)

As concerns the length of this transitional period, it was stipulated in recital 14 of Regulation (EC) No 1002/2004 that acceptance of the Special Enlargement Undertakings would be limited to an initial period of 12 months without prejudice to the normal duration of the existing measures. It follows from this that acceptance of new undertakings, but with the same provisions, could be accepted if the circumstances so warranted (e.g. if the conditions prevailing at the time of acceptance of the original undertakings still existed), provided that the transitional character of these exceptional measures is respected. Accordingly, in determining whether new undertakings are required, it is necessary to make an appraisal of the effectiveness of the measures.

C. APPRAISAL

(13)

Analysis of the monthly sales reports submitted to the Commission by the companies concerned backed up by available official statistical data showed that although there has been convergence in prices, a difference still appears to prevail between the prices charged by the companies with special Enlargement Undertakings for the product concerned to customers in the EU-10 and those prevailing in the Community as constituted before enlargement (EU-15).

(14)

The question of a shortage of supply on the EU-10 market was also raised by certain interested parties and the alleged inability of the Community Industry to supply potash to new customers in the EU-10 who, prior to enlargement, had traditionally sourced the product concerned from Belarus or Russia.

(15)

In this regard, it is to be expected that a period of re-adjustment would be required by the Community Industry given the complex logistical and sales network changes required for sales to the EU-10, to service what is in effect a new market for them. Nevertheless, the Commission found that intra-Community exports of potash from the largest producer in the EU-15 to customers in the EU-10 had more than doubled between 2003 and 2004, even if the starting point was comparatively low, which would indicate that partial changes to the structure of supply in the EU-25 have started to occur.

(16)

As concerns compliance with the special Enlargement Undertakings, verification visits to the exporting producers showed that the companies concerned had observed the MIPs and that the volumes exported to the EU-10 had not exceeded the levels of the quantitative ceilings stipulated in the undertakings. In addition, it was found that the companies were broadly respecting their traditional patterns of trade with individual customers in the EU-10.

(17)	Moreover, according to the information available, there have been no apparent ‘spill-overs’ from the EU-10 into the EU-15 of imports of the product concerned which had benefited from the exemption to the anti-dumping duties afforded by the undertakings.

D. CONCLUSION

1. General

(18)	The available information suggests that certain of the negative conditions which prevailed prior to enlargement and which necessitated the undertakings still appear to exist.

(19)

In addition, although there appear to have been some changes in the supply chain with Community Industry supplying more potash to the EU-10, information received from various interested parties indicated that there may be short term supply difficulties in the EU-10 for the product concerned, even though the Community Industry has started to increase its sales there.

(20)

It should also be recalled that a significant degree of difficulty in planning for potash customers in the EU-10 market has also undoubtedly been created due to (i) the fact that there was uncertainty in the market concerning whether the current anti-dumping measures would expire in May 2005 following their five-year imposition, and (ii) the unknown results of the two partial interim reviews for Russia initiated in April 2004 by the Commission.

(21)

In view of the foregoing, it is considered that particular account should be taken of the question of Community Interest and the concerns of the many importers and end users of potash in the EU-10. It is considered that the protection afforded by the current anti-dumping duties would still cause a degree of financial hardship to be suffered by the importers and end users if these anti-dumping duties were to be applied at the present time.

(22)

Therefore, on balance, it is concluded that the acceptance of new special Enlargement Undertakings offered by the companies concerned for a further period is justified as this will not only lessen the economic impact for buyers in the EU-10 but also help to alleviate the problems of supply in the EU-10 in the short term.

(23)

As concerns the length of the further period of application of the special Enlargement Undertakings, as mentioned above, an expiry review for Belarus and Russia and a partial interim review for Belarus was initiated on 13 April 2005. Given that the expiry review will normally be concluded within twelve months, it is considered appropriate to accept the new special Enlargement Undertakings until 13 April 2006.

(24)	Given also that the level of the anti-dumping measures for Belarus and Russia are being reviewed, it is considered appropriate to leave the level of the MIPs unchanged pending the outcome of these reviews.

(25)	With regard to the level of the quantitative ceilings to be applied, it should be noted that these correspond to the quantitative ceilings for the initial period of twelve months.

(26)

In conformity with Regulation (EC) No 992/2004, the undertakings oblige each individual producing exporter to respect MIPs within the framework of import ceilings and, in order that the undertakings can be monitored, the exporting producers concerned have also agreed to broadly respect their traditional selling patterns to individual customers in the EU-10. The exporting producers are also aware that if it is found that these sales patterns change significantly, or that the undertakings become in any way difficult or impossible to monitor, the Commission is entitled to withdraw acceptance of the company’s undertaking resulting in definitive anti-dumping duties being imposed in its place, or it may adjust the level of the ceiling, or it may take other remedial action.

(27)	It is also a condition of the undertakings that if they are breached in any way, the Commission will be entitled to withdraw acceptance thereof resulting in definitive anti-dumping duties being imposed in their place.

(28)	The companies will also provide the Commission with regular and detailed information concerning their exports to the Community, meaning that the undertakings can be monitored effectively by the Commission.

(29)

In order that the Commission can monitor effectively the companies’ compliance with the undertakings, when the request for release for free circulation pursuant to an undertaking is presented to the relevant customs authority, exemption from the duty will be conditional upon the presentation of an invoice containing at least the items of information listed in the Annex to Regulation (EC) No 992/2004. This level of information is also necessary to enable customs authorities to ascertain with sufficient precision that the shipment corresponds to the commercial documents. Where no such invoice is presented, or when it does not correspond to the product presented to customs, the appropriate anti-dumping duty will instead be payable.

2. Disclosure to interested parties

(30)	All interested parties which had previously made themselves known were advised of the intention to accept undertakings for a further period. No comments were received, however, which caused the Commission to alter its views on the matter.

E. REGISTRATION OF IMPORTS

(31)

Although the terms of the original undertakings have been observed during the initial period of their application by the companies concerned, there is still considered to be an inherent risk that breaches of the undertakings may occur, particularly towards the end of the period of application of these special measures.

(32)

It is therefore considered appropriate that customs authorities register imports into the Community of the product concerned originating in Belarus and Russia exported by the companies from which new special Enlargement Undertakings are accepted and for which an exemption from the anti-dumping duties imposed by Regulation (EEC) No 3068/92, as last amended by Regulation (EC) No 992/2004, is sought for a maximum period of nine months in accordance with Article 14(5) of the basic Regulation,

HAS ADOPTED THIS REGULATION:

Article 1

The undertakings offered by the exporting producers mentioned below, in connection with the anti-dumping proceeding concerning imports of potassium chloride originating in the Republic of Belarus and the Russian Federation are hereby accepted:

Country	Company	Taric Additional Code
Republic of Belarus	Produced and sold by Republican Unitary Enterprise Production Amalgamation Belaruskali, Soligorsk, Belarus, or produced by Republican Unitary Enterprise Production Amalgamation Belaruskali, Soligorsk, Belarus and sold by Belarus Potash Company, Minsk, Belarus, or JSC International Potash Company, Moscow, Russia, or Belurs Handelsgesellschaft mbH, Vienna, Austria, or UAB Baltkalis, Vilnius, Lithuania, to the first independent customer in the Community acting as an importer	A518
Russian Federation	Produced by JSC Silvinit, Solikamsk, Russia and sold by JSC International Potash Company, Moscow, Russia, or Belurs Handelsgesellschaft mbH, Vienna, Austria to the first independent customer in the Community acting as an importer	A519
Russian Federation	Produced and sold by JSC Uralkali, Berezniki, Russia or produced by JSC Uralkali, Berezniki, Russia and sold by Uralkali Trading SA, Geneva, Switzerland to the first independent customer in the Community acting as an importer	A520

Article 2

Customs authorities are hereby directed, pursuant to Article 14(5) of Regulation (EC) No 384/96 to take the appropriate steps to register the imports into the Community of potassium chloride originating in the Republic of Belarus or the Russian Federation falling within CN codes 3104 20 10 (TARIC codes 3104201010 and 3104201090), 3104 20 50 (TARIC codes 3104205010 and 3104205090), 3104 20 90, ex 3105 20 10 (TARIC codes 3105201010 and 3105201020), ex 3105 20 90 (TARIC codes 3105209010 and 3105209020), ex 3105 60 90 (TARIC codes 3105609010 and 3105609020), ex 3105 90 91 (TARIC codes 3105909110 and 3105909120), ex 3105 90 99 (TARIC codes 3105909910 and 3105909920) produced and sold or produced and exported by the companies listed in Article 1 for which an exemption to the anti-dumping duties imposed by Regulation (EEC) No 3068/92, as last amended by Regulation (EC) No 992/2004, is sought.

Registration shall expire nine months following the date of entry into force of this Regulation.

Article 3

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union and shall remain in force until 13 April 2006.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 6 June 2005.

For the Commission

Peter MANDELSON

Member of the Commission

(1) OJ L 56, 6.3.1996, p. 1. Regulation as last amended by Regulation (EC) No 461/2004 (OJ L 77, 13.3.2004, p. 12).

(2) OJ L 182, 19.5.2004, p. 23.

(3) OJ L 183, 20.5.2004, p. 16. Regulation as amended by Commission Regulation (EC) No 588/2005 (OJ L 98, 16.4.2005, p. 11).

(4) OJ L 308, 24.10.1992, p. 41. Regulation as last amended by Regulation (EC) No 992/2004.

(5) OJ L 112, 11.5.2000, p. 4. Corrigendum: OJ L 2, 5.1.2001, p. 42.

(6) OJ C 70, 20.3.2004, p. 15.

(7) OJ C 93, 17.4.2004, p. 2 and p. 3.

(8) OJ C 89, 13.4.2005, p. 3.

(9) OJ C 89, 13.4.2005, p. 7.

7.6.2005

Official Journal of the European Union

L 143/16

COMMISSION REGULATION (EC) No 859/2005

of 6 June 2005

fixing Community producer and import prices for carnations and roses with a view to the application of the arrangements governing imports of certain floricultural products originating in Jordan

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EEC) No 4088/87 of 21 December 1987 fixing conditions for the application of preferential customs duties on imports of certain flowers originating in Cyprus, Israel, Jordan, Morocco and the West Bank and the Gaza Strip (1), and in particular Article 5(2)(a) thereof,

Whereas:

(1)

Under Articles 2(2) and 3 of Regulation (EEC) No 4088/87, Community import and producer prices are fixed each fortnight for uniflorous (bloom) carnations, multiflorous (spray) carnations, large-flowered roses and small-flowered roses and apply for two-week periods. Under Article 1(b) of Commission Regulation (EEC) No 700/88 of 17 March 1988 laying down detailed rules for the application of the arrangements for the import into the Community of certain floricultural products originating in Cyprus, Israel, Jordan, Morocco and the West Bank and the Gaza Strip (2), those prices are determined for two-week periods on the basis of weighted prices provided by the Member States.

(2)	Those prices should be fixed immediately so the customs duties applicable can be determined.

(3)	Following the accession of Cyprus to the European Union on 1 May 2004, it is no longer necessary to fix import prices for Cyprus.

(4)

Likewise, it is no longer necessary to fix import prices for Israel, Morocco and the West Bank and the Gaza Strip, in order to take account of the agreements approved by Council Decisions 2003/917/EC of 22 December 2003 on the conclusion of an Agreement in the form of an Exchange of Letters between the European Community and the State of Israel concerning reciprocal liberalisation measures and the replacement of Protocols 1 and 2 to the EC-Israel Association Agreement (3), 2003/914/EC of 22 December 2003 on the conclusion of an Agreement in the form of an Exchange of Letters between the European Community and the Kingdom of Morocco concerning reciprocal liberalisation measures and the replacement of Protocols 1 and 3 to the EC-Morocco Association Agreement (4) and 2005/4/EC of 22 December 2004 on the conclusion of the Agreement in the form of an Exchange of Letters between the European Community and the Palestine Liberation Organisation (PLO) for the benefit of the Palestinian Authority of the West Bank and the Gaza Strip concerning reciprocal liberalisation measures and the replacement of Protocols 1 and 2 to the EC-Palestinian Authority Interim Association Agreement (5).

(5)	The Commission must adopt these measures in between the meetings of the Management Committee for Live Plants and Floriculture Products,

HAS ADOPTED THIS REGULATION:

Article 1

The Community producer and import prices for uniflorous (bloom) carnations, multiflorous (spray) carnations, large-flowered roses and small-flowered roses as referred to in Article 1 of Regulation (EEC) No 4088/87 shall be as set out in the Annex hereto for the period from 8 to 21 June 2005.

Article 2

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 6 June 2005.

For the Commission

J. M. SILVA RODRÍGUEZ

Director-General for Agriculture and Rural Development

(1) OJ L 382, 31.12.1987, p. 22. Regulation as last amended by Regulation (EC) No 1300/97 (OJ L 177, 5.7.1997, p. 1).

(2) OJ L 72, 18.3.1988, p. 16. Regulation as last amended by Regulation (EC) No 2062/97 (OJ L 289, 22.10.1997, p. 1).

(3) OJ L 346, 31.12.2003, p. 65.

(4) OJ L 345, 31.12.2003, p. 117.

(5) OJ L 2, 5.1.2005, p. 4.

ANNEX

(EUR/100 pieces)
Period from 8 to 21 June 2005
Community producer price	Uniflorous (bloom) carnations	Multiflorous (spray) carnations	Large-flowered roses	Small-flowered roses
	15,16	11,23	29,32	13,14
Community import prices	Uniflorous (bloom) carnations	Multiflorous (spray) carnations	Large-flowered roses	Small-flowered roses
Jordan	—	—	—	—

7.6.2005

Official Journal of the European Union

L 143/18

COMMISSION DIRECTIVE 2005/38/EC

of 6 June 2005

laying down the sampling methods and the methods of analysis for the official control of the levels of Fusarium toxins in foodstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption (1), and in particular Article 1(1) thereof,

Whereas:

(1)	Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs (2) provides for maximum limits for certain Fusarium toxins in certain foodstuffs.

(2)

Council Directive 89/397/EEC of 14 June 1989 on the official control of foodstuffs (3) lays down the general principles for the performance of control of foodstuffs. Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs (4) introduces a system of quality standards for laboratories entrusted by the Member States with the official control of foodstuffs.

(3)	Sampling plays a crucial part in the precision of the determination of the levels of Fusarium toxins, which are very heterogeneously distributed in a lot.

(4)	It is necessary to fix general criteria which the method of analysis should comply with in order to ensure that control laboratories use methods of analysis with comparable levels of performance.

(5)	The measures provided for in this Directive are in accordance with the opinion of the Standing Committee for the Food Chain and Animal Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Member States shall ensure that sampling for the official control of the levels of Fusarium toxins (deoxynivalenol, zearalenone, fumonisins B1 and B2 and T-2 and HT-2 toxin) in foodstuffs is carried out in accordance with the methods set out in Annex I.

Article 2

Member States shall ensure that sample preparation and methods of analyses used for the official control of the levels of Fusarium toxins (deoxynivalenol, zearalenone, fumonisins B1 and B2 and T-2 and HT-2 toxin) in foodstuffs comply with the criteria set out in Annex II.

Article 3

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 4

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 6 June 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission

(1) OJ L 372, 31.12.1985, p. 50. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

(2) OJ L 77, 16.3.2001, p. 1. Regulation last amended by Regulation (EC) No 856/2005 (See page 3 of this Official Journal).

(3) OJ L 186, 30.6.1989, p. 23.

(4) OJ L 290, 24.11.1993, p. 14. Directive as amended by Regulation (EC) No 1882/2003.

ANNEX I

METHODS OF SAMPLING FOR OFFICIAL CONTROL OF THE LEVELS OF FUSARIUM TOXINS IN CERTAIN FOODSTUFFS

1. Purpose and scope

Samples intended for official checking of the levels of Fusarium toxins content in foodstuffs shall be taken according to the methods set out in this Annex. Aggregate samples thus obtained shall be considered as representative of the lots. Compliance with maximum limits laid down in Annex I to Regulation (EC) 466/2001 shall be established on the basis of the levels determined in the laboratory samples.

2. Definitions

For the purpose of this Annex, the following definitions shall apply:

2.1. Lot: an identifiable quantity of a food commodity delivered at one time and determined by the official to have common characteristics, such as origin, variety, type of packing, packer, consignor or markings.

2.2. Sublot: designated part of a large lot in order to apply the sampling method on that designated part; each sublot must be physically separate and identifiable.

2.3. Incremental sample: a quantity of material taken from a single place in the lot or sublot.

2.4. Aggregate sample: the combined total of all the incremental samples taken from the lot or sublot.

3. General provisions

3.1. Personnel

Sampling shall be performed by an authorised person as designated by the Member State.

3.2. Material to be sampled

Each lot which is to be examined must be sampled separately. In accordance with the point 4.3, large lots must be subdivided into sublots to be sampled separately.

3.3. Precautions to be taken

In the course of sampling and preparation of the samples precautions, must be taken to avoid any changes, which would affect the Fusarium toxin content, adversely affect the analytical determination or make the aggregate samples unrepresentative.

3.4. Incremental samples

As far as possible incremental samples shall be taken at various places distributed throughout the lot or sublot. Departure from such procedure must be recorded in the record.

3.5. Preparation of the aggregate sample

The aggregate sample shall be made up by uniting the incremental samples.

3.6. Replicate samples

The replicate samples for enforcement, trade (defence) and reference (referee) purposes shall be taken from the homogenised aggregate sample, unless such procedure conflicts with Member States’ rules.

3.7. Packaging and transmission of samples

Each sample shall be placed in a clean, inert container offering adequate protection from contamination and against damage in transit. All necessary precautions shall be taken to avoid any change in composition of the sample, which might arise during transportation or storage.

3.8. Sealing and labelling of samples

Each sample taken for official use shall be sealed at the place of sampling and identified following the regulations of the Member State.

A record must be kept of each sampling, permitting each lot to be identified unambiguously and giving the date and place of sampling together with any additional information likely to be of assistance to the analyst.

4. Specific provisions

4.1. Different types of lots

Food commodities may be traded in bulk, containers, or individual packings, such as sacks, bags, retail packings. The sampling procedure may be applied to all the different forms in which the commodities are put on the market.

Without prejudice to the specific provisions set out in points 4.3, 4.4 and 4.5, the following formula may be used as a guide for the sampling of lots traded in individual packs, such as sacks, bags, retail packings.

—	weight: in kg

—	sampling frequency (SF): every nth sack or bag from which an incremental sample must be taken (decimal figures should be rounded to the nearest whole number).

4.2. Weight of the incremental sample

The weight of the incremental sample must be about 100 grams, unless otherwise defined in this Annex. In the case of lots in retail packings, the weight of the incremental sample shall depend on the weight of the retail packing.

4.3. General survey of the sampling procedure for cereals and cereal products

Table 1

Subdivision of lots into sublots depending on product and lot weight

Commodity	Lot weight (tonnes)	Weight or number of sublots	No incremental samples	Aggregate sample Weight (kg)
Cereals and cereal products	≥ 1 500	500 tonnes	100	10
	> 300 and < 1 500	3 sublots	100	10
	≥ 50 and ≤ 300	100 tonnes	100	10
	< 50	—	3-100 (*1)	1-10

4.4. Sampling procedure for cereals and cereal products for lots ≥ 50 tonnes

—

On condition that the sublot can be separated physically, each lot must be subdivided into sublots following Table 1. Taking into account that the weight of the lot is not always an exact multiple of the weight of the sublots, the weight of the sublot may exceed the mentioned weight by a maximum of 20 %.

—	Each sublot must be sampled separately.

—	Number of incremental samples: 100. Weight of the aggregate sample = 10 kg.

—

If it is not possible to carry out the method of sampling set out in this point because of the commercial consequences resulting from damage to the lot such as packaging forms, means of transport, an alternative method of sampling may be applied provided that it is as representative as possible and is fully described and documented.

4.5. Sampling procedure for cereals and cereal products for lots < 50 tonnes

For lots of cereals and cereal products less than 50 tonnes, the sampling plan must be used with 10 to 100 incremental samples, depending on the lot weight, resulting in an aggregate sample of 1 to 10 kg. For very small lots (≤ 0,5 tonnes) a lower number of incremental samples may be taken, but the aggregate sample uniting all incremental samples shall be also in that case at least 1 kg.

The figures in Table 2 may be used to determine the number of incremental samples to be taken.

Table 2

Number of incremental samples to be taken depending on the weight of the lot of cereals and cereal products

Lot weight (tonnes)	No of incremental samples
≤ 0,05	3
> 0,05-≤ 0,5	5
> 0,5-≤ 1	10
> 1-≤ 3	20
> 3-≤ 10	40
> 10-≤ 20	60
> 20-≤ 50	100

4.6. Sampling procedure for foods intended for infants and young children

—

The sampling procedure for cereals and cereal products as set out in point 4.5 shall apply to food intended for infants and young children. Accordingly the number of incremental samples to be taken shall depend on the weight of the lot, with a minimum of 10 and a maximum of 100, in accordance with Table 2 at point 4.5. For very small lots (≤ 0,5 tonnes) a lower number of incremental samples may be taken, but the aggregate sample uniting all incremental samples shall be also in that case at least 1 kg.

—

Weight of the incremental sample must be about 100 grams. In the case of lots in retail packing, the weight of the incremental sample shall depend on the weight of the retail packing and in case of very small lots (≤ 0,5 tonnes) the incremental samples must have a weight as such that uniting the incremental samples results in an aggregate sample of at least 1 kg.

—	Weight of aggregate sampling = 1-10 kg sufficiently mixed.

4.7. Sampling at retail stage

Sampling of foodstuffs at the retail stage must be done where possible in accordance with the sampling provisions set out in points 4.4. and 4.5. Where that is not possible, other effective sampling procedures at retail stage may be used provided that they ensure sufficient representativeness for the sampled lot.

5. Acceptance of a lot or sublot

—	Acceptance if the aggregate sample conforms to the maximum limit, taking into account the measurement uncertainty and correction for recovery.

—	Rejection if the aggregate sample exceeds the maximum limit beyond reasonable doubt taking into account the measurement uncertainty and correction for recovery.

(*1) Depending on the lot weight — see Table 2.

ANNEX II

SAMPLE PREPARATION AND CRITERIA FOR METHODS OF ANALYSIS USED IN OFFICIAL CHECKING OF THE LEVELS OF FUSARIUM TOXINS IN CERTAIN FOODSTUFFS

1. Precautions

As the distribution of Fusarium toxins is non-homogeneous, samples shall be prepared, and especially homogenised, with extreme care.

All the material received by the laboratory must be used for the preparation of test material.

2. Treatment of the sample as received in the laboratory

Each laboratory sample must be finely grinded and mixed thoroughly using a process that has been demonstrated to achieve complete homogenisation.

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 procedure that has been demonstrated to determine accurately the dry matter content.

3. Subdivision of samples for enforcement and defence purposes

The replicate samples for enforcement, trade (defence) and referee purposes shall be taken from the homogenised material unless such procedure conflicts with Member States’ rules on sampling.

4. Method of analysis to be used by the laboratory and laboratory control requirements

4.1. Definitions

A number of the most commonly used definitions that the laboratory shall be required to use are the following:

The most commonly quoted precision parameters are repeatability and reproducibility.

r	=	Repeatability, the value below which the absolute difference between two single test results obtained under repeatability conditions, namely same sample, same operator, same apparatus, same laboratory, and short interval of time may be expected to lie within a specific probability (typically 95 %) and hence r = 2,8 × sr
sr	=	Standard deviation, calculated from results generated under repeatability conditions
RSDr	=	Relative standard deviation, calculated from results generated under repeatability conditions
R	=	Reproducibility, the value below which the absolute difference between single test results obtained under reproducibility conditions, namely on identical material obtained by operators in different laboratories, using the standardised test method may be expected to lie within a certain probability (typically 95 %); R = 2,8 × sR
sR	=	Standard deviation, calculated from results under reproducibility conditions
RSDR	=	Relative standard deviation calculated from results generated under reproducibility conditions .

4.2. General requirements

Methods of analysis used for food control purposes must comply with the provisions of items 1 and 2 of the Annex to Directive 85/591/EEC.

4.3. Specific requirements

4.3.1. Performance Criteria

Where no specific methods for the determination of Fusarium toxins levels in foodstuffs are required by Community legislation, laboratories may select any method provided the selected method meets the following criteria:

(a)

Performance characteristics for deoxynivalenol

Level μg/kg	Deoxynivalenol
Level μg/kg	RSDr %	RSDR %	Recovery %
> 100-≤ 500	≤ 20	≤ 40	60 to 110
> 500	≤ 20	≤ 40	70 to 120

(b)

Performance characteristics for zearalenone

Level μg/kg	Zearalenone
Level μg/kg	RSDr %	RSDR %	Recovery %
≤ 50	≤ 40	≤ 50	60 to 120
> 50	≤ 25	≤ 40	70 to 120

(c)

Performance characteristics for Fumonisin B1 and B2

Level μg/kg	Fumonisin B1 or B2
Level μg/kg	RSDr %	RSDR %	Recovery %
≤ 500	≤ 30	≤ 60	60 to 120
> 500	≤ 20	≤ 30	70 to 110

(d)

Performance characteristics for T-2 and HT-2 toxin

Level μg/kg	T-2 toxin
Level μg/kg	RSDr %	RSDR %	Recovery %
50-250	≤ 40	≤ 60	60 to 130
> 250	≤ 30	≤ 50	60 to 130

Level μg/kg	HT-2 toxin
Level μg/kg	RSDr %	RSDR %	Recovery %
100-200	≤ 40	≤ 60	60 to 130
> 200	≤ 30	≤ 50	60 to 130

The detection limits of the methods used are not stated as the precision values are given at the concentrations of interest.

The precision values are calculated from the Horwitz equation:

RSDR = 2(1-0,5logC)

where:

RSDR is the relative standard deviation calculated from results generated under reproducibility conditions

C is the concentration ratio (i.e. 1 = 100 g/100 g, 0,001 = 1 000 mg/kg

That is a generalised precision equation, which has been found to be independent of analyte and matrix but solely dependent on concentration for most routine methods of analysis.

4.3.2. ‘Fitness-for-purpose’ approach

In the case where there are a limited number of fully validated methods of analysis, alternatively, a ‘fitness-for-purpose’ approach, defining a single parameter, a fitness function, to evaluate the acceptability of methods of analysis may be used. A fitness function is an uncertainty function that specifies maximum levels of uncertainty regarded as fit for purpose.

Given the limited number of methods of analysis, fully validated by a collaborative trial, especially for the determination of T-2 and HT-2 toxin, the uncertainty function approach, specifying the maximum acceptable uncertainty, may also be used to assess the suitability (the ‘fitness-for-purpose’) of the method of analysis to be used by the laboratory. The laboratory may use a method which produces results within the maximum standard uncertainty. The maximum standard uncertainty may be calculated using the following formula:

where:

—	Uf is the maximum standard uncertainty (μg/kg)

—	LOD is the limit of detection of the method (μg/kg)

—	α is a constant, numeric factor to be used depending on the value of C. The values to be used are set out in Table 3

—	C is the concentration of interest (μg/kg).

If the analytical method provides results with uncertainty measurements less than the maximum standard uncertainty the method shall be considered being equally suitable to one which meets the performance characteristics given in point 4.3.1.

Table 3

Numeric values to be used for α as constant in formula set out in this point, depending on the concentration of interest

C (μg/kg)	α
≤ 50	0,2
51-500	0,18
501-1 000	0,15
1 001 -10 000	0,12
> 10 000	0,1

4.4. Recovery calculation and reporting of results

The analytical result must be reported corrected or uncorrected for recovery. The manner of reporting and the level of recovery must be reported. The analytical result corrected for recovery shall be used for checking compliance (see Annex I, point 5).

The analytical result must be reported as x +/– U whereby x is the analytical result and U is the expanded measurement uncertainty.

U is the expanded uncertainty, using a coverage factor of 2 which gives a level of confidence of approximately 95 %.

4.5. Laboratory quality standards

Laboratories must comply with Council Directive 93/99/EEC.

7.6.2005

Official Journal of the European Union

L 143/27

COMMISSION DECISION

of 27 November 2002

on the conclusion of a Cooperation Agreement between the European Atomic Energy Community and the Government of the Republic of Kazakhstan in the field of controlled nuclear fusion

(notified under document number C(2002) 4572)

(2005/419/Euratom)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Atomic Energy Community and in particular the second paragraph of Article 101 thereof,

Having regard to the approval of the Council (1),

Whereas the Agreement between the European Atomic Energy Community and the Government of the Republic of Kazakhstan in the field of nuclear fusion must be concluded,

HAS DECIDED AS FOLLOWS:

Article 1

The Agreement between the European Atomic Energy Community and the Government of the Republic of Kazakhstan in the field of controlled nuclear fusion is hereby concluded on behalf of the European Atomic Energy Community.

The text of the Agreement is appended to this Decision.

Article 2

The Member of the Commission responsible for Research or his designated representative is authorised to sign the Agreement on behalf of the European Atomic Energy Community for the purpose of binding the European Atomic Energy Community.

Done at Brussels, 27 November 2002.

For the Commission

Philippe BUSQUIN

Member of the Commission

(1) 12188/01 (press 333), 27.9.2001.

AGREEMENT

for cooperation between the Government of the Republic of Kazakhstan and the European Atomic Energy Community in the field of controlled nuclear fusion

THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN,

of the one part, and

THE EUROPEAN ATOMIC ENERGY COMMUNITY,

of the other part,

hereinafter referred to as ‘the Community’, both also generally referred to hereinafter as the ‘Party’ or ‘Parties’, as appropriate,

RECALLING that the Agreement on Partnership and Cooperation was signed on 23 January 1995 by the European Communities and their Members States and Kazakhstan;

DESIRING to facilitate the achievement of fusion energy as a potentially environmentally acceptable, economically competitive, and virtually limitless source of energy;

NOTING that the Community fusion programme is a broad-based comprehensive programme based on the toroidal magnetic confinement;

NOTING that the Fusion Programme of Kazakhstan is a focused programme concentrating on the specifics strengths of fusion science and technology in Kazakhstan;

RECOGNISING the mutual benefits to be obtained by establishing closer links between the Parties' scientific communities working in the field of controlled nuclear fusion;

DETERMINED to strengthen the cooperation between the Parties in the field of controlled nuclear fusion through regular consultations,

HAVE AGREED AS FOLLOWS:

Article 1

The objective of this Agreement is to maintain and intensify cooperation between the Parties in the areas covered by their respective fusion programmes on the basis of mutual benefit in order to develop the scientific understanding and technological capability underlying a fusion power system.

Article 2

Cooperation under this Agreement may be undertaken in the following areas:

(a)	experimental and theoretical studies of plasma confinement, transport, heating and current drive (including the development of related RF systems) and diagnostics, in magnetic devices;

(b)	fusion technology;

(c)	applied plasma physics;

(d)	programme policies and plans; and

(e)	other areas as may be agreed.

Article 3

Cooperation in the areas referred to in Article 2 may include the following activities:

(a)	exchange and provision of information;

(b)	exchange and provision of personnel;

(c)	meetings of various forms;

(d)	exchange and provision of samples, instruments and apparatus for experimental and evaluation purposes;

(e)	balanced participation in joint studies and activities;

(f)	involvement in either Party’s contribution to the fusion programmes or projects involving third parties, subject to the consent, if required, of such third parties; and

(g)	other activities as may be agreed.

Article 4

1. To the extent necessary, implementing arrangements on specific cooperative actions shall be concluded between:

the Community or any organisation associated with it within the framework of the Community fusion programme, designated by the Community for this purpose;

Government of the Republic of Kazakhstan, the executive body of which for those purposes is the Ministry of Energy and Mineral Resources of the Republic of Kazakhstan or any other organisation, designated by the Republic of Kazakhstan for this purpose.

2. Specific terms and conditions necessary to implement activities listed in Article 3 shall be mutually agreed by both parties in the implementing arrangements and shall contain:

(a)	specific details, procedures and financing provisions for individual cooperative activities;

(b)	assignment of the responsibility for the operational management of the concerned activity to a single organisation or operating agent;

(c)	detailed provisions on dissemination of information and treatment of intellectual property.

3. Each Party shall coordinate its activities under this Agreement as appropriate, with other international activities related to research and development in the field of controlled nuclear fusion in which the other Party is a participant, in order to minimise duplication of effort.

Article 5

1. The Parties shall establish a Coordinating Committee to coordinate and to supervise the execution of this Agreement. Each of the Parties shall appoint an equal number of members to the Coordinating Committee and nominate one of its appointed members as its Head of Delegation. The Coordinating Committee shall meet each year, alternately in the Community and in Kazakhstan or at any other agreed time and place. The Head of Delegation of the receiving Party shall chair the meeting.

2. The functions of the Coordinating Committee shall include:

(a)	assessing the state of cooperation under this Agreement;

(b)	determining the specific tasks to be undertaken in the areas referred to in Article 2 of this Agreement, without prejudice to the taking of autonomous decisions by the Parties on their respective programmes.

3. All decisions of the Coordinating Committee shall be by unanimity.

4. For periods between meetings of the Coordinating Committee, each Party shall nominate an Executive Secretary to act on its behalf in all matters concerning cooperation under this Agreement. The Executive Secretaries shall be responsible for day-to-day management of such cooperation.

Article 6

All costs resulting from the cooperation shall be borne by the Party that incurs them, unless otherwise specifically agreed in writing by the implementing agencies.

Article 7

Utilisation and diffusion of information and intellectual property rights including industrial property, patents and copyrights connected with the cooperative activities under this Agreement shall be in accordance with the Annexes, which form an integral part of this Agreement.

Article 8

Nothing in this Agreement shall be construed to prejudice existing or future arrangements for cooperation between the Parties.

Article 9

1. Performance of the Parties under this Agreement shall be subject to the availability of appropriated funds.

2. Cooperation under this Agreement shall be in accordance with the laws and regulations applicable.

3. Each Party shall use its best endeavours, within the framework of the laws and regulations applicable, to facilitate the accomplishment of formalities involved in the movement of persons, the transfer of materials and equipment and the transfer of currency required to conduct the cooperation.

4. Compensation for damages incurred during the implementation of this Agreement shall be in accordance with the laws and regulations applicable.

Article 10

Subject to the laws and regulations applicable, the Parties shall endeavour to settle all questions connected with this Agreement through consultations between themselves.

Article 11

1. This Agreement shall enter into force on the date (1) which the Parties, by an exchange of diplomatic notes, specify for its entry into force and shall remain in force for an initial period of 10 years.

2. Thereafter, this Agreement shall be automatically renewed for five-year periods, unless either Party, by written notice, requests its termination or renegotiation not later than six months prior to the expiry date.

3. In the event of termination or renegotiation, this Agreement shall remain in force in its previous form, with respect to cooperation activities effectively entered into prior to the request for termination or renegotiation and to implementing arrangements as envisaged in Article 4, until the end of such activities and arrangements.

4. Termination of this Agreement shall not affect rights and obligations under Article 7.

Article 12

This Agreement shall apply, in so far as the Community is concerned, to the territories in which the Treaty establishing the European Atomic Energy Community applies and to the territories of the countries participating in the Community fusion programme as fully associated third States.

Article 13

This Agreement shall be drawn up in duplicate in the Danish, Dutch, English, Finnish, French, German, Greek, Italian, Portuguese, Spanish, Swedish, Kazakh and Russian languages, each text being equally authentic.

Done in Brussels, 29 November 2002.

For the European Atomic Energy Community

Philippe BUSQUIN

For the Government of the Republic of Kazakhstan

Akhmetzhan S. YESSIMOV

(1) 13 April 2004.

ANNEX I

Guiding principles on the allocation of intellectual property rights (*1) resulting from joint research under the Cooperation Agreement in the field of controlled nuclear fusion

I. OWNERSHIP, ALLOCATION AND EXERCISE OF RIGHTS

All research carried out pursuant to this Agreement shall be ‘joint research’. The participants shall jointly develop joint technology management plans (TMPs) (*2) in respect of the ownership and use, including publication, of information and intellectual property (IP) to be created in the course of joint research. Those plans shall be approved by the Parties before the conclusion of any specific R & D cooperation contracts to which they refer. The TMPs shall be developed taking into account the aims of the joint research, the relative contributions of the participants, the advantages and disadvantages of licensing by territory or for fields of use, requirements imposed by laws applicable and other factors deemed appropriate by the participants. The rights and obligations concerning the research generated by visiting researchers in respect of IP shall also be addressed in the joint technology management plans.

Information or IP created in the course of joint research and not addressed in the technology management plan shall be allocated, with the approval of the Parties, according to the principles set out in the technology management plan. In case of disagreement, such information or IP shall be owned jointly by all the participants involved in the joint research from which the information or IP results. Each participant to whom this provision applies shall have the right to use such information or IP for his own commercial exploitation with no geographical limitation.

Each Party shall ensure that the other Party and its participants may have the rights to IP allocated to them in accordance with these principles.

While maintaining the conditions of competition in areas affected by the Agreement each Party shall endeavour to ensure that rights acquired pursuant to this Agreement are exercised in such a way as to encourage in particular:

(i)	the dissemination and use of information created, disclosed, or otherwise made available, under the Agreement;

(ii)	the adoption and implementation of international standards.

II. COPYRIGHT WORKS

Copyright belonging to the Parties or to their participants shall be accorded treatment consistent with the Berne Convention (1971 Paris Act).

III. SCIENTIFIC LITERARY WORKS

Without prejudice to Section IV, unless otherwise agreed in the TMP, publication of results of research shall be made jointly by the Parties or participants to that joint research. Subject to the foregoing general rule, the following procedures shall apply:

in the case of publication by a Party or public bodies of that Party of scientific and technical journals, articles, reports, books, including video and software, arising from joint research pursuant to this Agreement, the other Party shall be entitled to a worldwide, non-exclusive, irrevocable, royalty-free licence to translate, reproduce, adapt, transmit and publicly distribute such works;

2.	the Parties shall ensure that literary works of a scientific character arising from joint research pursuant to this Agreement and published by independent publishers shall be disseminated as widely as possible;

all copies of a copyrights work to be publicly distributed and prepared under this provision shall indicate the names of the author(s) of the work unless an author or authors expressly declines or decline to be named. They shall also bear a clearly visible acknowledgement of the cooperative support of the Parties.

IV. UNDISCLOSED INFORMATION

A. Documentary undisclosed information

Each Party or its participants, as appropriate, shall identify at the earliest possible moment and preferably in the technology management plan the information that it wishes to remain undisclosed in relation to this Agreement, taking account, inter alia, of the following criteria:

—	secrecy of the information in the sense that the information is not, as a body or in the precise configuration or assembly of its components, generally known among or readily accessible by lawful means to experts in the field,

—	the actual or potential commercial value of the information by virtue of its secrecy,

—	previous protection of the information in the sense that it has been subject to steps that were reasonable under the circumstances by the person lawfully in control, to maintain its secrecy.

The Parties and the participants may in certain cases agree that, unless otherwise indicated, parts or all of the information provided, exchanged or created in the course of joint research pursuant to the Agreement may not be disclosed.

Each Party shall ensure that undisclosed information under this Agreement and its ensuing privileged nature is readily recognisable as such by the other Party, for example by means of an appropriate marking or restrictive legend. This also applies to any reproduction of the said information, in whole or in part.

A Party receiving undisclosed information pursuant to the Agreement shall respect the privileged nature thereof. These limitations shall automatically terminate when this information is disclosed by the owner without restriction to experts in the field.

Undisclosed information communicated under this Agreement may be disseminated by the receiving Party to persons within or employed by the receiving Party, and other concerned departments or agencies in the receiving Party authorised for the specific purposes of the joint research under way, provided that any undisclosed information so disseminated shall be pursuant to an agreement of confidentiality and shall be readily recognisable as such, as set out above.

With the prior written consent of the Party providing undisclosed information under this Agreement, the receiving Party may disseminate such undisclosed information more widely than otherwise permitted in paragraph 3 above. The Parties shall cooperate in developing procedures for requesting and obtaining prior written consent for such wider dissemination, and each Party will grant such approval to the extent permitted by its domestic policies, regulations and laws.

B. Non-documentary undisclosed information

Non-documentary undisclosed or other confidential or privileged information provided in seminars and other meetings arranged under this Agreement, or information arising from the attachment of staff, use of facilities, or joint projects, shall be treated by the Parties or their participants according to the principle specified for documentary information in the Agreement, provided, however, that the recipient of such undisclosed or other confidential or privileged information has been made aware of the confidential character of the information communicated at he time such communication is made.

C. Control

Each Party shall endeavour to ensure that undisclosed information received by it under this Agreement shall be controlled as provided therein. If one of the Parties becomes aware that it will be, or may reasonably be expected to become, unable to meet the non-dissemination provisions of paragraphs A and B, it shall immediately inform the other Party. The Parties shall thereafter consult to define an appropriate course of action.

(*1) Definitions of the concepts referred to in these guiding principles are set out in Annex II.

(*2) The indicative features of such TMPs are set out in Annex III.

ANNEX II

DEFINITIONS

1. INTELLECTUAL PROPERTY: shall have the meaning found in Article 2 of the Convention establishing the World Intellectual Property Organisation, done at Stockholm on 14 July 1967.

2. PARTICIPANT: any natural or legal person, including the Parties themselves, participating in a project under this Agreement.

3. JOINT RESEARCH: research implemented and/or funded by the joint contributions of the Parties and with collaboration from participants of both Parties, where appropriate.

4. INFORMATION: scientific or technical data, results or methods of research and development stemming from the JOINT RESEARCH and any other information deemed necessary by the Parties and/or participants engaged in the JOINT RESEARCH to be provided or exchanged under this Agreement or research pursuant thereto.

ANNEX III

INDICATIVE FEATURES OF A TECHNOLOGY MANAGEMENT PLAN (TMP)

The TMP is a specific agreement to be concluded between the participants, about the implementation of joint research and the respective rights and obligations of the participants. With respect to IP, the TMP will normally address, inter alia: ownership, protection, user rights for R & D purposes, exploitation and dissemination, including arrangements for joint publication, the rights and obligations of visiting researchers and dispute settlement procedures. The TMP may also address foreground and background information, licensing and deliverables.

7.6.2005

Official Journal of the European Union

L 143/34

COMMISSION DECISION

of 2 June 2005

amending Appendix A to Annex VIII to the 2003 Act of Accession as regards certain establishments in the milk, fish and meat sectors in Latvia

(notified under document number C(2005) 1609)

(Text with EEA relevance)

(2005/420/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to the Act of Accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia (1), and in particular Annex VIII, Chapter 4, Section B, Subsection I(1), paragraph (d) thereof,

Whereas:

(1)	Latvia has been granted transitional periods for certain establishments listed in Appendix A (2) to Annex VIII to the 2003 Act of Accession. That Appendix has been amended by Commission Decisions 2004/460/EC (3) and 2004/472/EC (4).

(2)	Latvia has submitted a declaration stating that certain establishments in the milk, fish and meat sectors have completed their upgrading process and are now in full compliance with Community legislation. Furthermore, certain establishments have ceased their activities.

(3)	Accordingly, it is appropriate to amend Appendix A to Annex VIII to the 2003 Act of Accession. However, for the sake of clarity, that Appendix should be replaced.

(4)	The Standing Committee on the Food Chain and Animal Health has been informed of the measures provided for in this Decision,

HAS ADOPTED THIS DECISION:

Article 1

Appendix A to Annex VIII to the 2003 Act of Accession is replaced by the Annex to this Decision.

Article2

This Decision is addressed to the Member States.

Done at Brussels, 2 June 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission

(1) OJ L 236, 23.9.2003, p. 33.

(2) OJ C 227 E, 23.9.2003, p. 104.

(3) OJ L 156, 30.4.2004, p. 78.

(4) OJ L 160, 30.4.2004, p. 61.

ANNEX

‘Appendix A

as referred to in Chapter 4, Section B, Subsection I, point 1 of Annex VIII (*1)

List of establishments, including shortcomings and deadlines for the correction of these shortcomings

MEAT ESTABLISHMENTS

Vet. No

Name of establishment

Shortcomings

Date of full compliance

Talsu gaļa, Akciju sabiedrība

Council Directive 64/433/EEC:

Annex I, Chapter I, point 1(a), (b), (c), (e) and (g)

Annex I, Chapter I, point 2(a)

Annex I, Chapter I, point 4(a)

Annex I, Chapter I, point 11

Annex I, Chapter II, point 14(e) and (f)

Annex I, Chapter III , point 15

Annex I, Chapter IV, point 16(b)

Annex I, Chapter IV, point 17(b)

Annex I, Chapter XIV, point 68

Council Directive 77/99/EEC:

Annex A, Chapter I, point 2(a), (b), (c), (d), (e), (f) and (g)

Annex A, Chapter I, points 6 and 11

Annex B, Chapter I, points 1 and 2

Annex B, Chapter II, point 3

Council Directive 94/65/EC:

Annex I, Chapter I, point 1(a)

Annex I, Chapter III, point 1(a)

31.12.2005

Tukuma gaļas pārstrādes sabiedrība, Akciju sabiedrība

Council Directive 64/433/EEC:

Annex I, Chapter I, point 1(a), (b), (c), (e), (f) and (g)

Annex I, Chapter I, point 2(a)

Annex I, Chapter I, point 4(a)

Annex I, Chapter I, point 11

Annex I, Chapter II, point 14(e) and (f)

Annex I, Chapter III, point 15

Annex I, Chapter IV, point 16(b)

Annex I, Chapter IV, point 17(b)

Annex I, Chapter XIV, point 68

Council Directive 77/99/EEC:

Annex A, Chapter I, point 2(a), (b), (c), (d), (e), (f) and (g)

Annex A, Chapter I, points 6 and 11

Annex B, Chapter I, points 1 and 2

Annex B, Chapter II, point 3

Council Directive 94/65/EC:

Annex I, Chapter I, point 1(a)

Annex I, Chapter III, point 1(a)

31.12.2005

Triāls filiāle „Valmieras gaļas kombināts“, Sabiedrība ar ierobežotu atbildību

Council Directive 64/433/EEC:

Annex I, Chapter I, point 1(a), (b), (c), (e), (f) and (g)

Annex I, Chapter I, point 2(a)

Annex I, Chapter I, point 4(a)

Annex I, Chapter I, point 11

Annex I, Chapter II, point 14(e) and (f)

Annex I, Chapter III, point 15

Council Directive 77/99/EEC:

Annex A, Chapter I, point 2(a), (b), (c), (d), (e), (f) and (g)

Annex A, Chapter I, points 6 and 11

Annex B, Chapter I, points 1 and 2

Annex B, Chapter II, point 3

Council Directive 94/65/EC:

Annex I, Chapter I, point 1(a)

Annex I, Chapter III, point 1(a)

31.12.2005

Gravendāle, Sabiedrība ar ierobežotu atbildību

Council Directive 64/433/EEC:

Annex I, Chapter I, point 1(a), (b), (c), (e) and (g)

Annex I, Chapter I, point 2(a)

Annex I, Chapter I, point 11

Annex I, Chapter III, point 15

Council Directive 77/99/EEC:

Annex A, Chapter I, point 2(a), (b), (c), (d), (e), (f) and (g)

Annex A, Chapter I, point 11

Annex B, Chapter I, points 1 and 2

Council Directive 94/65/EC:

Annex I, Chapter I, point 1(a)

Annex I, Chapter III, point 1(a)

31.12.2005

Putnu fabrika Ķekava, Akciju sabiedrība

Council Directive 71/118/EEC:

Annex I, Chapter I, point 1(a), (b), (c), (e) and (g)

Annex I, Chapter I, point 4(c)

Annex I, Chapter II, point 14(b) and 14(c)

Annex I, Chapter V, point 18(d)

Annex I, Chapter VII, point 43

Council Directive 77/99/EEC:

Annex A, Chapter I, point 2(a), (b), (c), (d) and (e)

Annex A, Chapter I, point 11

Annex B, Chapter I, points 1 and 2

Council Directive 94/65/EC:

Annex I, Chapter III, point 1(a)

31.12.2005

Erso7, Sabiedrība ar ierobežotu atbildību

Council Directive 64/433/EEC:

Annex II, Chapter 1, point 4(a)

Annex II, Chapter 1, point 9

Council Directive 77/99/EEC:

Annex A, Chapter I, point 2(f)

Annex A, Chapter I, points 6 and 11

Annex B, Chapter I, points 1 and 2

31.12.2005

Strautmaļi, Zemnieku saimniecība

Council Directive 64/433/EEC:

Annex II, Chapter I, point 1(a), (b), (c) and (e)

Annex II, Chapter I, point 4(a)

Annex II, Chapter I, point 9

Council Directive 77/99/EEC:

Annex A, Chapter I, point 2(a), (b), (c), (d), (e) and (f)

Annex A, Chapter I, points 6 and 11

Annex B, Chapter I, points 1 and 2

Annex B, Chapter II, point 3

31.12.2005

Bērzlejas, Zemnieku saimniecība

Council Directive 64/433/EEC:

Annex II, Chapter I, point 1(a), (b), (c) and (e)

Annex II, Chapter I, point 4(a)

Annex II, Chapter I, point 9

Council Directive 77/99/EEC:

Annex A, Chapter I, point 2(a), (b) ,(c), (e) and (f)

Annex A, Chapter I, points 6 and 11

Annex B, Chapter I, points 1 and 2

31.12.2005

GPC Smārde, Sabiedrība ar ierobežotu atbildību

Council Directive 64/433/EEC:

Annex II, Chapter I, point 1(a), (c) and (e)

Annex II, Chapter I, point 4(a)

Annex II, Chapter I, point 9

Council Directive 77/99/EEC:

Annex A, Chapter I, point 2(b) and (c)

Annex A, Chapter I, point 11

Annex B, Chapter I, points 1 and 2

31.12.2005’

(*1) For the text of Annex VIII see OJ L 236, 23.9.2003, p. 824.

7.6.2005

Official Journal of the European Union

L 143/38

COMMISSION DECISION

of 3 June 2005

amending Appendix B to Annex IX to the 2003 Act of Accession as regards certain establishments in the meat, milk and fish sectors in Lithuania

(notified under document number C(2005) 1633)

(Text with EEA relevance)

(2005/421/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to the Act of Accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia (1), and in particular Annex IX, Chapter 5, Section B, Subsection I, paragraph (d) thereto,

Whereas:

(1)	Lithuania has been granted transitional periods for certain establishments listed in Appendix B to Annex IX to the 2003 Act of Accession.

(2)	The Appendix B to Annex IX to the 2003 Act of Accession has been amended by Commission Decisions 2004/472/EC (2) and 2004/473/EC (3).

(3)	According to an official declaration from the Lithuanian competent authority, certain establishments in the meat, milk and fish sectors have completed their upgrading process and are now in full compliance with Community legislation. Furthermore, certain establishments have ceased their activities.

(4)	The Appendix B to Annex IX to the 2003 Act of Accession should therefore be amended accordingly. For the sake of clarity, it should be replaced.

(5)	The Standing Committee on the Food Chain and Animal Health has been informed of the measures provided for in this Decision,

HAS ADOPTED THIS DECISION:

Article 1

The Appendix B to the Annex IX to the 2003 Act of Accession is replaced by the Annex to this decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 3 June 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission

(1) OJ L 236, 23.9.2003, p. 33.

(2) OJ L 160, 30.4.2004, p. 62.

(3) OJ L 160, 30.4.2004, p. 68.

ANNEX

‘Appendix B

referred to in Chapter 5, Section B, Subsection I of Annex IX (*1)

List of establishments, including shortcomings and deadlines for the correction of these shortcomings

MEAT ESTABLISHMENTS

Initial list

Vet. No

Name of establishment

Shortcomings

Date of full compliance

77-23

UAB „Jatkančių mėsinė“, Jatkančių k., Tauragės r., Tauragės aps.

Council Directive 64/433/EEC:

Annex I, Chapter I, point 1

Annex I, Chapter I, point 2

Annex I, Chapter I, point 4(c)

Annex I, Chapter I, points 9, 11 and 12

Annex I, Chapter II, point 14(a), (b), (c), (e), (f), (g), (h), (k), and (l)

Annex I, Chapter III, point 15(b),

Council Directive 77/99/EEC:

Annex A, Chapter I, point 1

Annex A, Chapter I, point 2(a), (b), (c), (d), (e), (f) and (g)

Annex A, Chapter I, points 3, 4, 6, 7, 8, 9, 11, 12, and 15

Annex B, Chapter I, point 1(a), (d), (e) and (f)

Annex B, Chapter I, point 2(d), (e), (h), and (i)

1.11.2006

77-02

UAB „Stragutės mėsa“

Council Directive 64/433/EEC:

Annex I, Chapter I, point 1(a), (b), (c), (e), (f), and (g)

Annex I, Chapter I, point 2

Annex I, Chapter I, points 11 and 12

Annex I, Chapter II, point 14(a), (b), (c), (e), (g), (h), (k), and (l)

Annex I, Chapter III, point 15(b)

Council Directive 77/99/EEC:

Annex A, Chapter I, point 1

Annex A, Chapter I, point 2(a), (b), (c), (d), (e), (f) and (g)

Annex A, Chapter I, points 3, 4, 6, 8, 9, 11 and 15

Annex B, Chapter I, point 1(a), (d), (e) and (f)

Annex B, Chapter I, point 2(a), (b) and (j)

1.11.2006

88-01

AB „Grabupėliai“

Council Directive 64/433/EEC:

Annex I, Chapter I, point 1

Annex I, Chapter I, point 2

Annex I, Chapter I, point 4(c)

Annex I, Chapter I, points 5, 9, 11 and 12

Annex I, Chapter II, point 14(b), (c), (d), (e), (h), (k) and (l)

Annex I, Chapter III, point 15(b) and (d)

Annex I, Chapter IV, point 16(a)

Council Directive 77/99/EEC:

Annex A, Chapter I, point 1

Annex A, Chapter I, point 2(a), (b), (c), (d), (e), (f), and (g)

Annex A, Chapter I, points 4, 6, 7, 8, 9, 11 and 15

Annex B, Chapter I, point 1(a) and (f)

Annex B, Chapter I, point 2(c), (d), (i) and (j)

1.11.2006

HC-Meat products establishments

41-20

UAB „Rukesa ir ko“

Council Directive 64/433/EEC:

Annex I, Chapter I, point 1(a), (b), (c), (e), (f) and (g)

Annex I, Chapter III, point 15(b)

Council Directive 77/99/EEC:

Annex A, Chapter I, point 1

Annex A, Chapter I, point 2(a), (b), (c), (d), (e), (f) and (g)

Annex A, Chapter I, points 3, 7, 8, 11, 12, 14 and 15

Annex B, Chapter I, point 1

Annex B, Chapter I, point 2(c), (d), (e) and (h)

1.5.2006

72-01

BĮ „Litmos“

Council Directive 64/433/EEC:

Annex I, Chapter I, point 1

Annex I, Chapter I, point 2(a)

Annex I, Chapter III, point 15(b)

Council Directive 77/99/EEC:

Annex A, Chapter I, point 1

Annex A, Chapter I, point 2(a), (b), (c), (d), (e), (f) and (g)

Annex A, Chapter I, points 3, 4, 6, 7, 8, 9, 11, 12, 13, 14 and 15

Annex B Chapter I, point 1

Annex B Chapter I, point 2(a), (b), (c), (d), (e), (h), (i) and (j)

Council Directive 94/65/EC:

Annex I, Chapter I, point 1(a)

1.11.2006

AB „Vilniaus mėsos kombinatas“

Council Directive 77/99/EEC:

Annex A, Chapter I, point 1

Annex A, Chapter I, point 2(a), (b), (c) and (d)

Annex A, Chapter I, points 4, 12 and 15

Annex B, Chapter I, point 1(d), (e) and (f)

Annex B, Chapter I, point 2(b) and (d)

1.12.2004

01-23

UAB „Esla“

Council Directive 77/99/EEC:

Annex A, Chapter I, point 1

Annex A, Chapter I, point 2(a), (c), (e) and (g)

Annex A, Chapter I, points 7, 8, 11, 13 and 14

Annex B, Chapter I, point 1(d) and (f)

1.12.2004

01-29

UAB „Naujasodžio mėsa“

Council Directive 77/99/EEC:

Annex A, Chapter I, point 1

Annex A, Chapter I, point 2(a), (b), (c), (d), (e), (f) and (g)

Annex A, Chapter I, points 11 and 15

Annex B, Chapter I, point 1

Annex B, Chapter I, point 2(c)

1.12.2005

LC-Meat products establishments

77-32

V. Pietarienės IĮ

Council Directive 64/433/EEC:

Annex I, Chapter I, point 1(c) and (e)

Annex I, Chapter III, point 15(b)

Council Directive 77/99/EEC:

Annex A, Chapter I, point 1

Annex A, Chapter I, point 2(b), (c), (d), (e) and (g)

Annex A, Chapter I, points 3, 4, 6, 11, 12, 13 and 14

Annex B, Chapter I, point 1(a), (d) and (e)

Annex B, Chapter I, point 2(a), and (j)

1.1.2006

10.

27-13

UAB „Guostė“

Council Directive 64/433/EEC:

Annex I, Chapter I, point 1(c), (e) and (f)

Council Directive 77/99/EEC:

Annex A, Chapter I, point 1

Annex A, Chapter I, point 2(d) and (e)

Annex A, Chapter I, points 3, 4, 8, 9, 11, 13, and 15

Annex B, Chapter I, point 2(a), (d) and (j)

1.11.2006

Supplementary list

No	Veterinary approval number	Name and address of establishment	Sector: Meat				Date of compliance
			Activity of the establishments
			Fresh meat, Slaughter, Cutting	Meat products	Minced meat, Meat preparation	Cold store
1.	16	UAB „Alytaus mėsinė“, Pramonės g. 16, Alytaus m., Alytaus aps.	X				1.5.2005
2.	84 02	UAB „Samsonas“, Striūpų k., Šakių sen., Šakių r., Marijampolės aps.	X				1.5.2005
3.	57 03	ŽŪB „Antašavos centras“, Astravų k., Kupiškio r., Panevėžio aps.	X				1.5.2005
4.	87 11	ŽŪB „Kontautėliai“, Kantautalių k., Šilalės r., Tauragės aps.	X				1.5.2005
5.	88 19	UAB „Aisytė“, Vilkyčių k., Šilutės r., Klaipėdos aps.	X	X	X		1.5.2005
6.	91 01	UAB „Kužių agroįmonė“, Kužių k., Šiaulių r., Šiaulių aps.	X	X	X	1.5.2005
7.	54 13	UAB „Molavėna“, Beržėnų k., Kelmės r., Šiaulių aps.	X	X	X		1.5.2005
8.	65 23	ŽŪK „Getautų ūkininkas“, Getautų k., Pakruojo r., Šiaulių aps.	X	X	X	1.5.2005
9.	32 02	UAB „Norpa“, Šapnagių k., Akmenės r., Šiaulių aps.	X	X	X	1.5.2005
10.	71 16	UAB „Ropokalnis“, Žvejų g. 2, Šeduva, Radviliškio r., Šiaulių aps.	X	X	X		1.5.2005
11.	68 03	UAB „Burgis“, Babrungėnų k., Babrungo sen., Plungės r., Telšių aps.	X	X	X		1.5.2005
12.	41 05	UAB „Cesta“, Žemoji Riešė, Vilniaus r., Vilniaus aps.	X	X	X	1.5.2005
13.	85 18	UAB „Olkusjana“, Jašiūnų k., Šalčininkų r., Vilniaus aps.	X	X	X		1.5.2005
14.	81 07	UAB „Geras skonis“, Alionių k., Ukmergės r., Vilniaus aps.	X	X	X	1.5.2005
15.	49 03	UAB „Gelombickienė ir partneriai“, Slėnio g. 2, Rumšiškės, Kaišiadorių r., Kauno aps.		X			1.5.2005
16.	51 08	I. Medžiuvienės f. „Čečeta“, Čečetų k., K. Rūdos sen., K. Rūdos sav., Marijampolės aps.		X	X		1.5.2005
17.	39 24	UAB „Damsa“, Basanavičiaus g. 57, Kybartai, Vilkaviškio r., Marijampolės aps.		X	X		1.5.2005
18.	51 10	UAB „Sasnelė“, Bitikų k. Sasnavos sen., Marijampolės sav., Marijampolės aps.		X	X	1.5.2005
19.	51 02	UAB „Lavirda“, Patašinės k., Marijampolės sen., Marijampolės sav., Marijampolės aps.		X	X		1.5.2005
20.	91 08	Šlepkų ŽŪB, Gergždos k., Šiaulių r., Šiaulių aps.	X	X	X		1.5.2005
21.	47 26	ŽŪB „Delikatesas“, Kudirkos g. 2, Joniškio r., Šiaulių aps.	X	X	X	1.5.2005
22.	34 04	UAB „Agrogrupė“, Katlierių k., Skiemonių sen., Anykščių r., Utenos aps.	X	X	X		1.5.2005
23.	67 14	ŽŪK „Mikoliškio paukštynas“, Mykoliškio k., Pasvalio r., Panevėžio aps.	X			1.5.2005

FISH ESTABLISHMENTS

Initial list

Vet. No

Name of establishment

Shortcomings

Date of full compliance

66-25

UAB „Lipresa“

Council Directive 91/493/EEC:

Annex, Chapter III.I, point 1

Annex, Chapter III.I, point 2(a), (d), (e) and (h)

Annex, Chapter III.I, points 3, 6, 9, 10 and 11

Annex, Chapter IV.IV, point 6(a)

1.11.2006

55-27

UAB „Myxum“

Council Directive 91/493/EEC:

Annex, Chapter III.I, point 1

Annex, Chapter III.I, point 2(a), (c), (d), (e) and (h)

Annex, Chapter III.I, points 5, 9 and 10

Annex, Chapter IV.V, point 1

Annex, Chapter VIII, point 1

1.11.2006

Supplementary list

No	Veterinary approval number	Name and address of establishment	Sector: Fish	Date of compliance
			Activity of the establishments
			Fish and fish products
1.	55 31	L. Šemetulskio IĮ, Girkaliai, Kretingalė, Klaipėdos r.	X	1.5.2005

MILK ESTABLISHMENTS

Initial list

Vet. No

Name of establishment

Shortcomings

Date of full compliance

54-01P

UAB „Kelmės pieninė“

Council Directive 92/46/EEC:

Annex B, Chapter I, point 2(a), (b), (c), (d), (e), (f) and (g)

Annex B, Chapter I, points 3, 11 and 13

1.11.2006

Supplementary list

No	Veterinary approval number	Name and address of establishment	Sector: Milk	Date of compliance
			Activity of the establishments
			Milk and milk based products
1.	47 01 P	ŽŪB „Bariūnai“, Bariūnų k., Joniškio r., Šiaulių aps.	X	1.5.2005’

(*1) For the text of Annex IX see OJ L 236, 23.9.2003, p. 836.

		ISSN 1725-2555
Official Journal of the European Union		L 143

English edition	Legislation	Volume 48 7 June 2005

Contents		I Acts whose publication is obligatory	page
		Commission Regulation (EC) No 855/2005 of 6 June 2005 establishing the standard import values for determining the entry price of certain fruit and vegetables	1
	*	Commission Regulation (EC) No 856/2005 of 6 June 2005 amending Regulation (EC) No 466/2001 as regards Fusarium toxins ( 1 )	3
	*	Commission Regulation (EC) No 857/2005 of 6 June 2005 amending Regulation (EC) No 622/2003 laying down measures for the implementation of the common basic standards on aviation security ( 1 )	9
	*	Commission Regulation (EC) No 858/2005 of 6 June 2005 accepting undertakings offered in connection with the anti-dumping proceeding concerning imports of potassium chloride originating in the Republic of Belarus or the Russian Federation and making imports of potassium chloride originating in the Republic of Belarus and the Russian Federation subject to registration	11
		Commission Regulation (EC) No 859/2005 of 6 June 2005 fixing Community producer and import prices for carnations and roses with a view to the application of the arrangements governing imports of certain floricultural products originating in Jordan	16
	*	Commission Directive 2005/38/EC of 6 June 2005 laying down the sampling methods and the methods of analysis for the official control of the levels of Fusarium toxins in foodstuffs ( 1 )	18

(EUR/100 kg)
CN code	Third country code (1)	Standard import value
0702 00 00	052	111,0
	204	82,9
	999	97,0
0707 00 05	052	92,9
0707 00 05	999	92,9
0709 90 70	052	92,6
	624	107,4
	999	100,0
0805 50 10	388	61,2
	508	50,9
	528	56,8
	624	65,6
	999	58,6
0808 10 80	204	70,2
	388	85,0
	400	147,8
	404	126,8
	508	65,8
	512	64,0
	524	66,5
	528	67,2
	624	173,6
	720	91,6
	804	93,8
	999	95,7
0809 10 00	052	232,4
0809 10 00	999	232,4
0809 20 95	052	335,3
	400	451,9
	999	393,6

	II Acts whose publication is not obligatory
	Commission
*	Commission Decision of 27 November 2002 on the conclusion of a Cooperation Agreement between the European Atomic Energy Community and the Government of the Republic of Kazakhstan in the field of controlled nuclear fusion (notified under document number C(2002) 4572)	27
	Agreement for cooperation between the Government of the Republic of Kazakhstan and the European Atomic Energy Community in the field of controlled nuclear fusion	28
*	Commission Decision of 2 June 2005 amending Appendix A to Annex VIII to the 2003 Act of Accession as regards certain establishments in the milk, fish and meat sectors in Latvia (notified under document number C(2005) 1609) ( 1 )	34
*	Commission Decision of 3 June 2005 amending Appendix B to Annex IX to the 2003 Act of Accession as regards certain establishments in the meat, milk and fish sectors in Lithuania (notified under document number C(2005) 1633) ( 1 )	38
*	Commission Decision of 3 June 2005 authorising France to make use of the system established by Title I of Regulation (EC) No 1760/2000 to replace the May survey of bovine livestock (notified under document number C(2005) 1626) ( 1 )	45