(1)

Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction (1) provides, in Article 21 thereof, that the European Monitoring Centre for Drugs and Drug Addiction shall be open to the participation of any third country that shares the interests of the Union and its Member States in the Centre’s objectives and work.

(2)

On 11 July 2006 the Council authorised the Commission to open negotiations with the Republic of Croatia for an Agreement between the European Union and the Republic of Croatia on the participation of the Republic of Croatia in the work of the European Monitoring Centre for Drugs and Drug Addiction (hereinafter ‘the Agreement’). The negotiations were successfully concluded by the initialling of the Agreement.

(3)

The Agreement should be signed on behalf of the Union, subject to its conclusion,

(1)

Article 37 of Regulation (EC) No 1234/2007 provides that when the average Community market price for pig carcasses as established by reference to the prices recorded in each Member State on the representative markets of the Community and weighted by means of coefficients reflecting the relative size of the pig herd in each Member State is, and is likely to remain, at less than 103 % of the reference price, the Commission may decide to grant aid for private storage.

(2)

Market prices have fallen below that level and, given seasonal and cyclical trends, this situation could persist. In view of this, it is therefore appropriate to grant aid for private storage.

(3)

Article 31 of Regulation (EC) No 1234/2007 provides that a private storage aid maybe granted for pigmeat and that aid shall be fixed by the Commission in advance or by means of tendering procedure.

(4)

Commission Regulation (EC) No 826/2008 of 20 August 2008 laying down common rules for the granting of private storage aid for certain agricultural products (2) has established common rules for the implementation of the private storage aid scheme.

(5)

Pursuant to Article 6 of Regulation (EC) No 826/2008 an aid fixed in advance is to be granted in accordance with the detailed rules and conditions provides for in Chapter III of that Regulation.

(6)

In order to facilitate the management of the measure, the pigmeat products are classified in categories according to similarities with regard to the level of storage cost.

(7)

The closing date for the submission of applications should depend on market situation and should be decided in accordance with the procedure referred to in Article 195(2) of Regulation (EC) No 1234/2007.

(8)

In order to facilitate the administrative and control work relating to the conclusion of contracts, the minimum quantities of products each application must provide for should be fixed.

(9)

A security should be fixed in order to ensure the operators fulfil their contractual obligations and that the measure will have its desired effect on the market.

(10)

Exports of pigmeat products contribute to the restoring of the balance on the market. Therefore, provisions of Article 28(3) of Regulation (EC) No 826/2008 should apply when the storage period is shortened where products removed from storage are intended for export. Daily amounts to be applied for the reduction of the amount of the aid as referred to in that Article should be fixed.

(11)

For the purpose of application of the first subparagraph of Article 28(3) of Regulation (EC) No 826/2008 and for reason of consistency and clarity for operators, it is necessary to express in days the period of 2 months referred therein.

(12)

Article 35 of Regulation (EC) No 826/2008 provides for the information that the Member States have to notify to the Commission. It is appropriate to specify the rules on the notifications within the framework of the present Regulation.

(13)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets,

(1)

The representative prices and additional duties applicable to imports of white sugar, raw sugar and certain syrups for the 2010/11 marketing year are fixed by Commission Regulation (EU) No 867/2010 (3). These prices and duties have been last amended by Commission Regulation (EU) No 33/2011 (4).

(2)

The data currently available to the Commission indicate that those amounts should be amended in accordance with the rules and procedures laid down in Regulation (EC) No 951/2006,

(1)

Commission Regulation (EU) No 1017/2010 (2) has opened the sales of cereals by tendering procedures, in accordance with the conditions provided for in Commission Regulation (EU) No 1272/2009 of 11 December 2009 laying down common detailed rules for the implementation of Council Regulation (EC) No 1234/2007 as regards buying-in and selling of agricultural products under public intervention (3).

(2)

In accordance with Article 46(1) of Regulation (EU) No 1272/2009 and Article 4 of Regulation (EU) No 1017/2010, in the light of the tenders received in response to individual invitations to tender, the Commission has to fix for each cereal and per Member State a minimum selling price or to decide not to fix a minimum selling price.

(3)

On the basis of the tenders received for the fifth individual invitations to tender, it has been decided that a minimum selling price should be fixed for the cereals and for the Member States.

(4)

In order to give a rapid signal to the market and to ensure efficient management of the measure, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets,

(1)

Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs (2) authorises the use of 2,2-bis(4-hydroxyphenyl)propane, commonly known as Bisphenol A (hereinafter ‘BPA’), as monomer for the manufacture of plastic materials and articles intended to come into contact with foodstuffs in accordance with the opinions of the Scientific Committee on Food (hereinafter ‘SCF’) (3) and the European Food Safety Authority (hereinafter ‘the EFSA’) (4).

(2)

BPA is used as monomer in the manufacture of polycarbonate plastics. Polycarbonate plastics are used amongst others in the manufacture of infant feeding bottles. When heated under certain conditions small amounts of BPA can potentially leach out from food containers into foods and beverages and be ingested.

(3)

On 29 March 2010 the Danish Government informed the Commission and the Member States that it has decided to apply the safeguard measures provided for in Article 18 of Regulation (EC) No 1935/2004 and to temporarily ban the use of BPA for the manufacture of plastic materials in contact with food intended for children aged 0-3 (5).

(4)

The Danish Government substantiated its safeguard measure with a risk assessment provided on 22 March 2010 by the National Food Institute at the Technical University of Denmark (hereinafter ‘DTU Food’). The risk assessment covers the evaluation of a comprehensive study carried out on animals exposed to BPA in low doses monitoring the development of the nervous system and the behaviour in newborn rats. DTU Food has also evaluated whether the new data changes its previous evaluation of the toxic effects on the development of the nervous system and behaviour possibly caused by BPA.

(5)

In accordance with the procedure provided for in Article 18 of Regulation (EC) No 1935/2004 on 30 March 2010 the Commission asked the EFSA to give its opinion on the grounds adduced by Denmark for concluding that the use of the material endangers human health, although it complies with the relevant specific measures.

(6)

On 6 July 2010 the French Government informed the Commission, and on 9 July 2010 the Member States, that it has decided to apply the safeguard measures provided for in Article 18 of Regulation (EC) No 1935/2004 and to temporarily ban the manufacture, import, export and placing on the market of feeding bottles containing BPA (6).

(7)

The French Government substantiated its safeguard measure with two opinions issued by the French Food Safety Authority (AFSSA) on 29 January and 7 June 2010 and the report published on 3 June 2010 by the National Institute of Health and Medical Research (INSERM).

(8)

On 23 September 2010 the EFSA adopted the opinion of its Panel on food contact materials, enzymes, flavourings and processing aids (hereinafter ‘the Panel’) on BPA responding to the Commission’s request of 30 March 2010 as well as covering the evaluation of the specific neurobehavioural study evaluated in the Danish risk assessment and the review and evaluation of other recently published studies on BPA (7).

(9)

In its opinion the Panel concludes that based on the comprehensive evaluation of recent human and animal toxicity data, no new study could be identified, which would call for a revision of the current tolerable daily intake (hereinafter ‘TDI’) of 0,05 mg/kg bodyweight per day. This TDI is based on the no adverse effect level of 5 mg/kg bodyweight per day from a multi-generation reproductive toxicity study in rats, and the application of an uncertainty factor of 100, which is considered as conservative based on all information on BPA toxicokinetics. However, in a minority opinion one Member of the Panel concluded that the effects observed in certain studies raised uncertainties which may not be covered by the current TDI which should therefore be considered temporary until more robust data becomes available in the areas of uncertainty.

(10)

The Panel noted that some animal studies conducted on developing animals have suggested other BPA-related effects of possible toxicological relevance, in particular biochemical changes in brain, immune-modulatory effects and enhanced susceptibility to breast tumours. These studies have many shortcomings. The relevance of these findings in relation to human health cannot be assessed at present. In case any new relevant data becomes available in the future, the Panel will reconsider its opinion.

(11)

Infant formula or breast milk is the only source of nutrition for infants up to the age of 4 months, and it remains the major source of nutrition for some additional months. In its opinion of 2006 the EFSA concluded that infants aged 3 and 6 months fed using polycarbonate infant feeding bottles have the highest exposure to BPA, though below the TDI. For this group of infants the level of exposure to BPA decreases once feeding from polycarbonate bottles is phased out and other sources of nutrition become dominant.

(12)

Even if the infant has sufficient capacity to eliminate BPA at worst-case exposure the EFSA opinion pointed out that an infant’s system to eliminate BPA is not as developed as that of an adult and it only gradually reaches the adult capacity during the first 6 months.

(13)

The potential toxicological effects may have a higher impact in the developing organism. According to the opinions of the Scientific Committee on Food of 1997 (8) and 1998 (9) certain effects, in particular endocrine and reproductive effects, effects on the immune system and the neurodevelopment are of particular relevance to infants. Reproductive effects and neurodevelopmental effects of BPA have been studied extensively in standard multigeneration toxicological tests and in other studies, which took account of the developing organism and did not reveal effects in doses below the TDI. However, studies which could not be taken into account for setting the TDI due to many shortcomings showed BPA-related effects of possible toxicological relevance. These effects, in particular those on the biochemical changes in the brain, which may affect neurodevelopment, and on immune modulation are reflecting the area of particular concern for infants highlighted in the SCF opinions of 1997 and 1998. In addition, the EFSA opinion of 2010 mentions the enhancing effect of an early exposure to BPA on tumour formation later on in life when exposed to a carcinogen. Also in this case the sensitive stage is the developing organism. Thus the infant can be identified as the particular vulnerable part of the population as regards those findings for which the relevance for human health could not yet be fully assessed.

(14)

According to the EFSA opinion of 2006 polycarbonate feeding bottles is the main source of exposure to BPA for infants. Alternative materials to polycarbonate that do not contain BPA exist on the EU market, in particular glass and other plastic infant feeding bottles. These alternative materials have to comply with the strict safety requirements set out for food contact materials. Therefore, it is not necessary to continue the use of BPA-containing polycarbonate for infant feeding bottles.

(15)

Given that there exists a possible particular vulnerability of infants to potential effects of BPA, although also the infant is deemed to be able to eliminate BPA and even where the risk, notably to human health, has not yet been fully demonstrated, it is appropriate to reduce their exposure to BPA as much as reasonably achievable, until further scientific data is available to clarify the toxicological relevance of some observed effects of BPA, in particular as regards biochemical changes in brain, immune-modulatory effects and enhanced susceptibility to breast tumours.

(16)

The precautionary principle referred to in Article 7 of 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 (10) allows the Union to provisionally adopt measures on the basis of available pertinent information, pending an additional assessment of risk and a review of the measure within a reasonable period of time.

(17)

Taking into account that there are uncertainties in the present state of scientific research with regard to the harmfulness of BPA exposure to infants (11) through polycarbonate infant feeding bottles that would need to be clarified, the Commission is entitled to take a preventive measure regarding the use of BPA in polycarbonate infant feeding bottles on the basis of the precautionary principle which is applicable in a situation in which there is scientific uncertainty, even if the risk, notably to human health, has not yet been fully demonstrated.

(18)

Thus, it is necessary and appropriate for the achievement of the basic objective of ensuring a high level of human health protection to obviate sources of danger to physical and mental health that may be caused to infants by BPA exposure through feeding bottles.

(19)

The Commission evaluated the infant feeding bottle market and received an indication by the relevant producers that voluntary action by the industry for replacements on the market are ongoing and the economic impact of the proposed measure is limited. Therefore, all BPA-containing infant feeding bottles on the EU market should be replaced by the middle of 2011.

(20)

Until further scientific data are available to clarify the toxicological relevance of some observed effects of BPA, in particular as regards biochemical changes in brain, immune-modulatory effects and enhanced susceptibility to breast tumours, the use of BPA in the manufacture and placing on the market of polycarbonate infant feeding bottles should be temporarily banned. Directive 2002/72/EC should therefore be amended accordingly. The Authority has a mandate to monitor new studies to clarify these endpoints.

(21)

Following the evaluation of the technical and economic feasibility to implement the proposed measure it is concluded that the measure is no more restrictive of trade than is required to achieve the high level of health protection chosen in the Union.

(22)

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

(1)

Article 136(1)(a) TFEU foresees the possibility of adopting measures specific to the Member States whose currency is the euro with a view to strengthening the coordination and surveillance of their budgetary discipline.

(2)

Article 126 TFEU establishes that Member States are to avoid excessive government deficits and sets out the excessive deficit procedure to that effect. The Stability and Growth Pact, which in its corrective arm implements the excessive deficit procedure, provides the framework supporting government policies for a prompt return to sound budgetary positions taking account of the economic situation.

(3)

On 27 April 2009, the Council decided, in accordance with Article 104(6) of the Treaty establishing the European Community that an excessive deficit existed in Greece.

(4)

On 10 May 2010, the Council adopted Decision 2010/320/EU (1) (hereinafter ‘the Decision’) addressed to Greece under Article 126(9) TFEU and Article 136 TFEU with a view to reinforcing and deepening fiscal surveillance and giving notice to Greece to take measures for the deficit reduction judged necessary to remedy the situation of excessive deficit at the latest by the deadline of 2014. The Council established the following path for the deficit correction: government deficit not exceeding EUR 18 508 million in 2010, EUR 17 065 million in 2011, EUR 14 916 million in 2012, EUR 11 399 million in 2013 and EUR 6 385 million in 2014.

(5)

According to the forecast available at the time the Council adopted the Decision, real GDP was expected to contract by 4 % in 2010 and 2,5 % in 2011, and recover afterwards, with growth rates of 1,1 % in 2012, and 2,1 % in 2013 and in 2014. GDP deflator was expected to be 1,2 %, – 0,5 %, 1,0 %, 0,7 % and 1,0 % for the years 2010 to 2014, respectively. Given economic developments, real GDP is now expected to contract by 4,25 % in 2010 and 3 % in 2011 and recover afterwards with growth rates of 1,1 % in 2012, and 2,1 % in 2013 and in 2014. GDP deflators are now expected to be 3,0 %, 1,5 %, 0,4 %, 0,8 % and 1,2 % for the years 2010 to 2014, respectively.

(6)

On 7 September 2010, the Council adopted Decision 2010/486/EU (2) amending the Decision.

(7)

On 15 November 2010 Eurostat validated the Greek government deficit and debt statistics, in accordance with Council Regulation (EC) No 479/2009 of 25 May 2009 on the application of the Protocol on the excessive deficit procedure annexed to the Treaty establishing the European Community (3). On that occasion, the deficit and debt series for the years 2006-2009 were revised upwards. The government deficit ratio-to-GDP for 2009 was revised from 13,6 % of GDP to 15,4 % of GDP, while the debt ratio was revised from 115,1 % of GDP to 126,8 % of GDP.

(8)

Greece has made good progress in the implementation of the measures required by the Decision, including the reduction of government deficit. However, the aforesaid revision in statistical series along with weak revenue collection and other problems with budgetary implementation, including the accumulation of payables, imply that the government deficit ceiling for 2010 will most likely be missed. This slippage will have to be fully offset in the course of 2011.

(9)

On 24 November 2010, Greece submitted to the Council and the Commission a report outlining the policy measures taken to comply with the Decision. The Commission assessed the report and concluded that Greece is satisfactorily complying with the Decision.

(10)

In light of the above considerations, it appears appropriate to amend the Decision in a number of respects, while keeping unchanged the deadline for the correction of the excessive deficit and the adjustment path for the government deficit and the increase of government debt in nominal terms,

(1)

in Article 1(3), the second sentence is replaced by the following:

‘Based on November 2010 GDP projections, the corresponding path for the debt-to-GDP ratio shall not exceed 143 % in 2010, 153 % in 2011, 157 % in 2012, 158 % in 2013 and 156 % in 2014.’;

(2)

in Article 2(3), point (b) is replaced by the following:

(3)

in Article 2(3), point (g) is deleted;

(4)

in Article 2(3), point (k) is replaced by the following:

(5)

in Article 2(3), point (m) is replaced by the following:

(6)

in Article 2(3), point (o) is replaced by the following:

(7)

in Article 2(3), point (p) is deleted;

(8)

in Article 2(3), the following points are added:

(9)

in Article 2(4), point (a) is deleted;

(10)

in Article 2(4), the following points are added:

(11)

in Article 2(5), point (b) is replaced by the following:

(12)

in point (d) of Article 2(5), the years ‘2010-2060’ are replaced by the years ‘2009-2060’;

(13)

in Article 2(5), the following point is added:

(14)

in Article 2(6), point (a) is replaced by the following:

(15)

in Article 2(7), point (c) is deleted;

(16)

in Article 2(7), the following points are added: