26.8.2014   

EN

Official Journal of the European Union

L 252/1

(1)

Regulation (EEC) No 2658/87 established a nomenclature of goods (hereinafter referred to as the ‘Combined Nomenclature’), which is set out in Annex I to that Regulation.

(2)

The classification of pieces of fish meat as fillets or other fish meat in heading 0304 of the Combined Nomenclature depends on whether such pieces can be identified as having been obtained from fish fillets.

(3)

The term ‘loins’ is used as a synonym for fillets of big fish in the Combined Nomenclature. Since heading 1604 of the Combined Nomenclature, covering prepared or preserved fish, makes already reference to ‘fillets known as loins’ such a reference should also be introduced in Chapter 3 of the Combined Nomenclature, covering fish.

(4)

Taking into account the anatomy of big fish such as tuna (of the genus Thunnus), swordfish (Xiphias gladius), marlin, sailfish and spearfish (of the family Istiophoridae), as well as oceanic sharks (Hexanchus griseus; Cetorhinus maximus; family Alopiidae; Rhincodon typus; family Carcharhinidae; family Sphyrnidae; family Isuridae), a maximum of four relatively large fish fillets per fish can be obtained (from the right and left side as well as from the upper and lower side).

(5)

In order to ensure a consistent application of the Combined Nomenclature, the classification of fish fillets referred to as ‘loins’ (whether or not cut into pieces) obtained from big fish, under heading 0304, should be clarified.

(6)

An Additional Note should therefore be inserted in Chapter 3 of Part Two of the Combined Nomenclature to ensure its uniform interpretation throughout the Union.

(7)

Annex I to Regulation (EEC) No 2658/87 should therefore be amended accordingly.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

26.8.2014   

EN

Official Journal of the European Union

L 252/3

(1)

Commission Directive 2008/125/EC (2) included tebuconazole as active substance in Annex I to Council Directive 91/414/EEC (3) for use as a fungicide, under the condition that the Member States concerned ensure that the notifiers at whose request tebuconazole was included in that Annex provides further confirmatory information in the form of studies on the risk for birds and mammals.

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

(3)

On 8 April 2010 one of the notifiers at whose request tebuconazole was included in Annex I to Directive 91/414/EEC, submitted an application for an amendment to the conditions of approval of the active substance tebuconazole to allow uses as a plant growth regulator to be authorised without restriction. That application was accompanied by information relating to the requested additional supported use as plant growth regulator in oilseed rape. It was submitted to Denmark, which had been designated rapporteur Member State by Commission Regulation No. 1490/2002 (5).

(4)

Denmark assessed the information submitted by the notifier. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’, on 23 July 2012.

(5)

The Commission consulted the Authority which presented its opinion on the risk assessment of tebuconazole on 9 December 2013 (6). The draft assessment report, the addendum and the opinion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised within the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 in the format of the Commission review report for tebuconazole.

(6)

The Commission invited the notifier to submit its comments on the review report for tebuconazole.

(7)

The Commission has come to the conclusion that allowing uses as a plant growth regulator to be authorised without restriction does not cause any risks in addition to those already taken into account in the approval of tebuconazole and in the Commission review report for that substance.

(8)

It is appropriate to extend the approval of tebuconazole to cover uses as a plant growth regulator without restriction. However, in order to take into account the remaining uncertainty on the potential for groundwater exposure of the metabolite 1,2,4-triazole for the representative spray uses on cereals, as a barley seed treatment and on grapes, Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil or climatic conditions, in particular as regards the occurrence in groundwater of the metabolite 1,2,4-triazole.

(9)

In January 2014, Denmark finalized the evaluation of the confirmatory information as regards the risk to birds and mammals. The Standing Committee on Plants, Animals, Food and Feed agrees that, on the basis of the current outcome, the risk to birds and mammals is acceptable. Therefore, the conclusions of the original risk assessment are not substantially affected by the evaluation of the submitted confirmatory data. No further review by the Authority has been considered necessary.

(10)

The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(11)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

26.8.2014   

EN

Official Journal of the European Union

L 252/6

(1)

In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For metaflumizone the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2006/517/EC (3).

(2)

In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 29 March 2005 an application from BASF SE. for the inclusion of the active substance metaflumizone in Annex I to Directive 91/414/EEC. Decision 2006/517/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

(3)

For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 29 March 2005. In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (4) additional information was requested from the applicant on 5 July 2011. The evaluation of the additional data by the United Kingdom was submitted in the format of an updated draft assessment report on 8 June 2012.

(4)

The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance metaflumizone (5) on 13 September 2013. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised within the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 in the format of the Commission review report for metaflumizone.

(5)

It has appeared from the various examinations made that plant protection products containing metaflumizone may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve metaflumizone.

(6)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

(7)

A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

(8)

Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing metaflumizone. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

(9)

The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (6) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

(10)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (7) should be amended accordingly.

(11)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(a)

in the case of a product containing metaflumizone as the only active substance, where necessary, amend or withdraw the authorisation by 30 June 2016 at the latest; or

(b)

in the case of a product containing metaflumizone as one of several active substances, where necessary, amend or withdraw the authorisation by 30 June 2016 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

26.8.2014   

EN

Official Journal of the European Union

L 252/11

(1)

Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use.

(2)

Commission Regulation (EU) No 231/2012 (2) lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008.

(3)

The Union list of food additives and the specifications may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council either on the initiative of the Commission or following an application (3).

(4)

The European Food Safety Authority (hereinafter: ‘the Authority’), in its opinion of 22 May 2008 (4) recommended to lower the tolerable weekly intake (TWI) for aluminium to 1 mg/kg body weight/week. In addition, the Authority considered that the revised TWI was generally exceeded for high consumers, especially children, in a significant part of the Union. In order to ensure that the revised TWI is not exceeded, the conditions of use and the use levels for food additives containing aluminium, including aluminium lakes were amended by Commission Regulation (EU) No 380/2012 (5).

(5)

Regulation (EU) No 380/2012 provides that aluminium lakes prepared from all colours listed in Table 1 of Part B of Annex II to Regulation (EC) No 1333/2008 are authorised until 31 July 2014. From 1 August 2014 only aluminium lakes prepared from the colours listed in Table 3 of Part A of Annex II to Regulation (EC) No 1333/2008 are authorised and only in those food categories where provisions on maximum limits on aluminium coming from lakes are explicitly stated in Part E of that Annex.

(6)

Applications for authorisation of the use of aluminium lakes of riboflavins (E 101) and the extension of use of aluminium lakes of cochineal, carminic acid, carmines (E 120) were submitted in the course of 2013 and have been made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. While considering the applications a special attention was paid to a possible exposure to aluminium in order not to undermine Regulation (EU) No 380/2012.

(7)

In aluminium lakes of colours the dye is rendered insoluble and functions differently to its dye equivalent (e.g. improved light, pH and heat stability, preventing colour bleed and providing a different colour shade to dye colours) making the lake form suitable for certain specific technical applications.

(8)

The authorisation of aluminium lakes of riboflavins provides an alternative to aluminium lakes of other yellow colours in foods in which the use of aluminium lakes is authorised. The use levels requested for aluminium lakes of cochineal, carminic acid, carmines are low and the extension of use is either to niche products or to products which are not consumed by children. A higher use level for pasteurised fish roe is needed due to the heat treatment to guarantee a stable colour during the shelf life of the product. It is not expected that the authorisation of aluminium lakes of riboflavins and the extension of use of aluminium lakes of cochineal, carminic acid, carmines would have a significant impact on the total exposure to aluminium.

(9)

Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the Authority in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where such update is not liable to have an effect on human health. Since the authorisation of aluminium lakes of riboflavins and the extensions of use of aluminium lakes of cochineal, carminic acid, carmines constitute updates of that list which are not liable to have an effect on human health, it is not necessary to seek the opinion of the Authority.

(10)

Annex to Regulation (EU) No 231/2012 stipulates that a colour may be used in the form of aluminium lakes only where explicitly stated. Therefore, the authorisation of aluminium lakes of riboflavins (E 101) requires modification of the specifications for that food additive provided in the Annex to Regulation (EU) No 231/2012 with regard to use of aluminium lakes of colours.

(11)

Therefore, Annex II to Regulation (EC) No 1333/2008 and Annex to Regulation (EU) No 231/2012 should be amended accordingly.

(12)

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

26.8.2014   

EN

Official Journal of the European Union

L 252/18

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,