12.7.2011   

EN

Official Journal of the European Union

L 182/1

12.7.2011   

EN

Official Journal of the European Union

L 182/2

(1)

Finland submitted a request to the Commission that mixtures of wastes classified under Basel entries B3040 and B3080 be considered for inclusion in Annex IIIA to Regulation (EC) No 1013/2006.

(2)

The United Kingdom submitted a request to the Commission that mixtures of wastes classified under Basel entry B3020 be considered for inclusion in Annex IIIA to Regulation (EC) No 1013/2006.

(3)

The Commission received comments from Belgium, Czech Republic, Denmark, Germany, Italy, Luxembourg, Netherlands, Austria, Poland, Portugal, Romania, Slovenia, Finland and Sweden with regard to the acceptability of mixing waste corresponding to different indents or sub-indents of Basel entries B1010, B2010, B2030, B3010, B3020, B3030, B3040 and B3050 to be considered for inclusion in Annex IIIA to Regulation (EC) No 1013/2006. Taking into account those comments, the Commission selected a list of mixtures of wastes classified under one single Basel entry for inclusion in Annex IIIA to Regulation (EC) No 1013/2006.

(4)

The Commission assessed the requests by Finland and the United Kingdom and the comments of Member States and on the basis of that assessment, a list of mixtures of wastes classified under individual Basel entries for inclusion in Annex IIIA to Regulation (EC) No 1013/2006 was selected.

(5)

It is important to clarify which procedures are applicable to shipments of mixtures of wastes classified under one single Basel entry. In order to allow the export of some of those mixtures of wastes to countries to which Decision C(2001) 107/Final of the OECD Council concerning the revision of Decision C(92) 39/Final on control of transboundary movements of wastes destined for recovery operations (the OECD Decision) does not apply using the general information requirements laid down in Article 18 of Regulation (EC) No 1013/2006, a transitional period for those countries is necessary before they can inform the Commission, whether relevant mixtures of wastes may be exported to that country and of the applicable control procedure, if any.

(6)

Regulation (EC) No 1013/2006 should therefore be amended accordingly.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 39 of Directive 2008/98/EC of the European Parliament and of the Council (2),

12.7.2011   

EN

Official Journal of the European Union

L 182/5

(1)

Pursuant to Regulation (EC) No 1924/2006 health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.

(2)

Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’.

(3)

Following receipt of an application the Authority is to inform without delay the other Member States and the Commission thereof, and to deliver an opinion on the health claim concerned.

(4)

The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.

(5)

The three opinions referred to in this Regulation are related to applications for reduction of disease risk claims, as referred to in Article 14(1)(a) of Regulation (EC) No 1924/2006.

(6)

Following an application from Wrigley GmbH, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of sugar-free chewing gum and reduction of tooth demineralisation (Question No EFSA-Q-2010-00119) (2). The claim proposed by the applicant was worded as follows: ‘Chewing of sugar-free chewing gum remineralises tooth enamel which reduces the risk of dental caries’.

(7)

On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 1 October 2010 that a cause and effect relationship has been established between the consumption of sugar-free chewing gum and the claimed effect. Accordingly, a health claim reflecting this conclusion should be considered as complying with the requirements of Regulation (EC) No 1924/2006, and it should be included in the Union list of permitted claims.

(8)

Following an application from Wrigley GmbH, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of sugar-free chewing gum and neutralisation of plaque acids which reduces the risk of dental caries (Question No EFSA-Q-2010-00120) (3). The claim proposed by the applicant was worded as follows: ‘Chewing of sugar-free chewing gum neutralises plaque acids which reduces the risk of dental caries’.

(9)

On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 1 October 2010 that a cause and effect relationship has been established between the consumption of sugar-free chewing gum and the claimed effect. Accordingly, a health claim reflecting this conclusion should be considered as complying with the requirements of Regulation (EC) No 1924/2006, and it should be included in the Union list of permitted claims.

(10)

Article 16(4) of Regulation (EC) No 1924/2006 provides that an opinion in favour of authorising a health claim should include certain particulars. Accordingly, those particulars should be set out in Annex I to this Regulation as regards the authorised claims and include, as the case may be, the revised wording of the claims, specific conditions of use of the claims, and, where applicable, conditions or restrictions of use of the food and/or an additional statement or warning, in accordance with the rules laid down in Regulation (EC) No 1924/2006 and in line with the opinions of the Authority.

(11)

One of the objectives of Regulation (EC) No 1924/2006 is to ensure that health claims are truthful, clear and reliable and useful to the consumer, and that wording and presentation are taken into account in that respect. Therefore, where the wording of claims has the same meaning for consumers as that of an authorised health claim, because they demonstrate the same relationship that exists between a food category, a food or one of its constituents and health, they should be subject to the same conditions of use, as indicated in Annex I.

(12)

Following an application from GP International Holding BV, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of OPC Plus on the reduction of the risk of chronic venous insufficiency (Question No EFSA-Q-2009-00751) (4). The claim proposed by the applicant was worded as follows: ‘OPC Plus has been shown to increase the microcirculation and may therefore reduce the risk of chronic venous insufficiency’.

(13)

On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 7 September 2010 that a cause and effect relationship had not been established between the consumption of OPC Plus and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

(14)

The comments from the applicants and the members of the public received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting the measures provided for in this Regulation.

(15)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council have opposed them,

12.7.2011   

EN

Official Journal of the European Union

L 182/8

(1)

Pursuant to Regulation (EC) No 1924/2006 health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.

(2)

Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’.

(3)

Following receipt of an application the Authority is to inform without delay the other Member States and the Commission thereof and to deliver an opinion on the health claim concerned.

(4)

The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.

(5)

Following an application from Synbiotec S.r.l., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of Synbio on maintenance and improvement of intestinal well-being (Question No EFSA-Q-2009-00889) (2). The claim proposed by the applicant was worded as follows: ‘Synbio persists in the intestinal tract and favours the natural regularity contributing to maintain and improve human intestinal well-being’.

(6)

On 27 September 2010, the Commission and the Member States received the scientific opinion from the Authority, which concluded that on the basis of the data presented, a cause and effect relationship had not been established between the consumption of Synbio and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

(7)

Following an application from MILTE ITALIA SpA, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of Silymarin BIO-C® on increase in production of breast milk (Question No EFSA-Q-2009-00957) (3). The claim proposed by the applicant was worded, inter alia, as follows: ‘Suggested for improving the physiological production of breast milk during breast feeding’.

(8)

On 28 September 2010, the Commission and the Member States received the scientific opinion from the Authority, which concluded that on the basis of the data presented, a cause and effect relationship had not been established between the consumption of Silymarin BIO-C® and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

(9)

All the health claims subject to this Regulation are health claims as referred to in point (a) of Article 13(1) of Regulation (EC) No 1924/2006 and may benefit from the transition period laid down in Article 28(5) of that Regulation. As the Authority concluded that cause and effect relationships have not been established between the foods and the respective claimed effects, the two claims do not comply with Regulation (EC) No 1924/2006, and therefore they may not benefit from the transition period provided for in that Article.

(10)

In order to ensure that this Regulation is fully complied with, both food business operators and the national competent authorities should take the necessary actions to ensure that, at the latest 6 months following the entry into force of this Regulation, products bearing the health claims listed in its Annex are no longer present on the market.

(11)

The comments from the applicants and the members of the public received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting the measures provided for in this Regulation.

(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 and neither the European Parliament nor the Council have opposed them,

12.7.2011   

EN

Official Journal of the European Union

L 182/10

12.7.2011   

EN

Official Journal of the European Union

L 182/12

(1)

Annex VI to the Agreement on the European Economic Area (the ‘EEA Agreement’) contains specific provisions and arrangements concerning social security and Protocol 37 contains a list of Committees where EEA EFTA States participate.

(2)

It is appropriate to include Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems (2), Regulation (EC) No 988/2009 of the European Parliament and of the Council of 16 September 2009 amending Regulation (EC) No 883/2004 on the coordination of social security systems, and determining the content of its Annexes (3) and Regulation (EC) No 987/2009 of the European Parliament and Council of 16 September 2009 laying down the procedure for implementing Regulation (EC) No 883/2004 on the coordination of social security systems (4) in the EEA Agreement. In addition, it is appropriate to include a number of decisions and recommendations of the Administrative Commission. Furthermore, Protocol 37 should be amended to include in its list of committees the Administrative Commission for the coordination of social security systems, set up by Regulation (EC) No 883/2004.

(3)

Annex VI and Protocol 37 to the EEA Agreement should be amended accordingly,

12.7.2011   

EN

Official Journal of the European Union

L 182/24

(1)

Greenland is included in the list of overseas countries and territories set out in Annex II to the Treaties. In accordance with Article 198 of the Treaty on the Functioning of the European Union (hereinafter ‘the Treaty’), the purpose of the association of the overseas countries and territories with the Union is to promote the economic and social development of the overseas countries and territories and to establish close economic relations between them and the Union as a whole.

(2)

Denmark and Greenland have requested that veterinary checks between the Union and Greenland on fishery products, bivalve molluscs, echinoderms, tunicates, marine gastropods, by-products and products derived from these by-products that are regarded as originating in Greenland according to Annex III to Council Decision 2001/822/EC of 27 November 2001 on the association of the overseas countries and territories with the European Community (‘Overseas Association Decision’) (1), and of the same products which are introduced into Greenland from third countries, be permitted in accordance with the rules on sanitary and veterinary controls applicable to trade within the Union.

(3)

Trade in those products between Greenland and the Union should, therefore, be conducted in compliance with Union rules on animal health and food safety. Accordingly, Denmark and Greenland should undertake to ensure that consignments of products dispatched to the Union from Greenland are in conformity with the applicable Union rules concerning animal health and food safety. In particular, eligible feed and food business operators should be registered and listed in accordance with Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (2).

(4)

Veterinary checks at border inspection posts in Greenland should be carried out in accordance with Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (3). Veterinary checks at border inspection posts should be carried out in close cooperation with customs officials. To simplify those tasks it is appropriate to provide the competent authorities with references to the Combined Nomenclature (CN) specified in Annex I to Commission Decision 2007/275/EC of 17 April 2007 concerning lists of animals and products to be subject to controls at border inspection posts under Council Directives 91/496/EEC and 97/78/EC (4).

(5)

The competent authority in Greenland should provide official assurances to the Commission on the enforcement of the Union rules and animal health requirements for the products concerned. Those assurances should cover, in particular, compliance with the applicable provisions laid down in Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption (5), Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (6) and Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (7). Those assurances should also include a commitment to ensure compliance with the rules on trade within the Union.

(6)

Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products (8) requires the establishment of national monitoring plans for aquaculture animals. Accordingly, those provisions should also apply to Greenland.

(7)

In order to permit importation of the products covered by this Decision into the Union from Greenland in accordance with the rules on trade within the Union laid down in Union legal acts, as well as to ensure the sanitary safety of the products concerned, Denmark and Greenland should undertake to transpose and implement the relevant provisions of Union laws in Greenland, before the date from which this Decision should apply.

(8)

Denmark and Greenland should also undertake to ensure that imports into Greenland from third countries of the products concerned comply with Union rules on animal health and food safety.

(9)

Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (9) provides for the introduction of a computerised system linking veterinary authorities, with a view, in particular, to facilitate the rapid exchange of information relating to animal health and welfare between the competent authorities (Traces). Commission Decision 2004/292/EC of 30 March 2004 on the introduction of the Traces system (10) provides that the Member States are to use Traces from 1 April 2004. Traces is essential for the effective monitoring of trade in animals and products of animal origin and accordingly, it should be used for the transmission of data on movements and trade in such products between Greenland and the Union.

(10)

Outbreaks of animal diseases listed in Council Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases within the Community (11), are to be reported to the Commission through the Animal Disease Notification System (ADNS) in accordance with Commission Decision 2005/176/EC of 1 March 2005 laying down the codified form and the codes for the notification of animal diseases pursuant to Directive 82/894/EEC (12). For the products concerned, those provisions should also apply to Greenland.

(11)

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (13) established a rapid alert system for the notification of a direct or indirect risk to human health deriving from food or feed. Those provisions should also apply to Greenland for the products concerned.

(12)

Before Greenland can carry out veterinary checks on products that are introduced into Greenland from third countries, a Union inspection should be carried out in Greenland in order to verify that one or more border inspection posts in Greenland are in compliance with the requirements laid down in Directive 97/78/EC and Commission Regulation (EC) No 136/2004 of 22 January 2004 laying down procedures for veterinary checks at Community border inspection posts on products imported from third countries (14) and Commission Decision 2001/812/EC of 21 November 2001 laying down the requirements for the approval of border inspection posts responsible for veterinary checks on products introduced into the Community from third countries (15).

(13)

In the event that the results of such an inspection are positive, one or more border inspection posts in Greenland should be listed in Commission Decision 2009/821/EC of 28 September 2009 drawing up a list of approved border inspection posts, laying down certain rules on the inspections carried out by Commission veterinary experts and laying down the veterinary units in Traces (16). In order to ensure effective control of the products covered by this Decision introduced in Greenland and in the Union, it is appropriate that this Decision apply as from the moment at which one or more border inspection posts in Greenland are listed in Decision 2009/821/EC.

(14)

This Decision does not affect any possible arrangements related to the import of fishery products based on the Protocol (No 34) on special arrangements for Greenland annexed to the Treaties,

(a)

‘bivalve molluscs’ means molluscs as defined in point 2.1 of Section 2 of Annex I to Regulation (EC) No 853/2004;

(b)

‘fishery products’ means products as defined in point 3.1 of Section 3 of Annex I to Regulation (EC) No 853/2004;

(c)

‘by-products and products derived from these by-products’ means animal by-products and derived products within the meaning of points 1 and 2 respectively of Article 3 of Regulation (EC) No 1069/2009, as far as they are derived from fishery products, bivalve molluscs, echinoderms, tunicates or marine gastropods;

(d)

‘products originating from Greenland’ means products provided for in points (a), (b) and (c) of this Article, as defined in accordance with the provisions of Annex III to Decision 2001/822/EC.

(a)

the effective transposition and implementation in Greenland of the applicable rules laid down in legal acts of the Union concerning animal health and food safety, relating to the products;

(b)

the drawing-up and keeping up to date by the competent authorities in Denmark and Greenland of a list of feed and food business operators which have been registered in accordance with Article 31 of Regulation (EC) No 882/2004;

(c)

the conformity of consignments of products dispatched to the Union from Greenland with the applicable rules laid down in legal acts of the Union concerning animal health and food safety.

12.7.2011   

EN

Official Journal of the European Union

L 182/28

12.7.2011   

EN

Official Journal of the European Union

L 182/31

(1)

Pursuant to Article 18.1 of the Statute of the ESCB, the European Central Bank (ECB) and the national central banks of Member States whose currency is the euro may conduct credit operations with credit institutions and other market participants, with lending being based on adequate collateral. The criteria determining the eligibility of collateral for the purposes of Eurosystem monetary policy operations are laid down in Annex I to Guideline ECB/2000/7 of 31 August 2000 on monetary policy instruments and procedures of the Eurosystem (1) (hereinafter referred to as the ‘General Documentation’).

(2)

Pursuant to Section 1.6 of the General Documentation, the Governing Council of the ECB may, at any time, change the instruments, conditions, criteria and procedures for the execution of Eurosystem monetary policy operations. Pursuant to Section 6.3.1 of the General Documentation, the Eurosystem reserves the right to determine whether an issue, issuer, debtor or guarantor fulfils its requirements for high credit standards on the basis of any information it may consider relevant.

(3)

The exceptional circumstances prevailing in the financial market, in conjunction with the fiscal position of the Portuguese Government, have disrupted the assessment by the market of securities issued by the Portuguese Government, with negative effects on the stability of the financial system. This exceptional situation requires a swift and temporary adaptation of the Eurosystem monetary policy framework.

(4)

The Governing Council has assessed the fact that the Portuguese Government has approved and is in the process of implementing an economic and financial adjustment programme, which it has negotiated with the European Commission, the ECB and the International Monetary Fund, and which the Portuguese Government has committed to fully implement. The Governing Council has also assessed, from a Eurosystem credit risk management perspective, the effects of such a programme on the securities issued by the Portuguese Government. The Governing Council considers the programme to be appropriate, so that, from a credit risk management perspective, the marketable debt instruments issued by the Portuguese Government or guaranteed by the Portuguese Government retain a quality standard sufficient for their continued eligibility as collateral for Eurosystem monetary policy operations, irrespective of any external credit assessment. These positive assessments provide the basis for an exceptional and temporary adaptation of the Eurosystem monetary policy framework, put in place with a view to contributing to the soundness of financial institutions, thereby strengthening the stability of the financial system as a whole and protecting the customers of those institutions.

(5)

The Governing Council will closely monitor the continued strong commitment of the Portuguese Government to fully implement the economic and financial adjustment programme underlying this exceptional and temporary adaptation of the Eurosystem monetary policy framework.

(6)

This exceptional adaptation of the Eurosystem monetary policy framework was decided and publicly announced by the Governing Council on 7 July 2011. It will apply temporarily, until the Governing Council considers that the stability of the financial system allows the normal application of the Eurosystem framework for monetary policy operations,