23.10.2010   

EN

Official Journal of the European Union

L 279/1

(1)

The Convention for the Protection of the Mediterranean Sea against Pollution, which was subsequently renamed as the Convention for the Protection of the Marine Environment and the Coastal Region of the Mediterranean (hereinafter referred to as ‘the Barcelona Convention’) was concluded on behalf of the European Community by the Council in Decisions 77/585/EEC (1) and 1999/802/EC (2).

(2)

In accordance with Article 4.3(e) of the Barcelona Convention, the Contracting Parties shall commit themselves to promote the integrated management of the coastal zones, taking into account the protection of areas of ecological and landscape interest and the rational use of natural resources.

(3)

The Recommendation of the European Parliament and of the Council of 30 May 2002, concerning the implementation of Integrated Coastal Zone Management in Europe (3), and in particular Chapter V thereof, encourages the implementation by the Member States of integrated coastal zone management in the context of existing conventions with neighbouring countries, including non-Member States, in the same regional sea.

(4)

The European Union promotes integrated management on a larger scale by means of horizontal instruments, including in the field of environmental protection, and by developing a sound scientific base for it, through its research programmes. These activities therefore contribute to integrated coastal zone management.

(5)

Integrated Coastal Zone Management is one component of the EU Integrated Maritime Policy as endorsed by the European Council held in Lisbon on 13 and 14 December 2007 and as also detailed in the Commission Communication ‘Towards an Integrated Maritime Policy for better governance in the Mediterranean’ and later welcomed by the General Affairs Council in its conclusions on Integrated Maritime Policy of 16 November 2009.

(6)

By Decision 2009/89/EC of 4 December 2008 (4), the Council signed the Protocol on Integrated Coastal Zone Management in the Mediterranean to the Barcelona Convention (hereinafter referred to as ‘the ICZM Protocol’) on behalf of the Community, subject to the subsequent conclusion of the ICZM Protocol at a later date.

(7)

Following the entry into force of the Treaty of Lisbon on 1 December 2009, the European Union notified the Government of Spain as regards the European Union having replaced and succeeded the European Community.

(8)

The Mediterranean coastal zones continue to experience severe environmental pressure and degradation of coastal resources. The ICZM Protocol provides a framework to stimulate a more concerted and integrated approach, involving public and private stakeholders including civil society and economic operators. Such an inclusive approach, based on best available scientific observation and knowledge, is required to address these problems more effectively and achieve a more sustainable development of the Mediterranean coastal zones.

(9)

The ICZM Protocol covers a broad range of provisions which will need to be implemented by different levels of administration, having regard to the principles of subsidiarity and proportionality.While it is appropriate for the Union to act in support of integrated coastal zone management, bearing in mind, inter alia, the cross-border nature of most environmental problems, the Member States and their relevant competent authorities will be responsible for the design and implementation on the coastal territory of certain detailed measures laid down in the ICZM Protocol, such as the establishment of zones where construction is not allowed.

(10)

The ICZM Protocol should be approved,

23.10.2010   

EN

Official Journal of the European Union

L 279/3

(1)

Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (2) lays down veterinary certification requirements for those commodities. Those requirements take into account whether or not additional guarantees or specific conditions are required due to the Newcastle disease status of those third countries, territories, zones or compartments.

(2)

Regulation (EC) No 798/2008 also lays down conditions for determining whether or not a third country, territory, zone or compartment is to be considered as free from Newcastle disease. One such criterion is that no vaccination against that disease is carried out using vaccines that do not comply with the criteria for recognised Newcastle disease vaccines set out in Part I of Annex VI to that Regulation. Point 2 of Part II of that Annex sets out specific criteria for Newcastle disease vaccines including for inactivated vaccines.

(3)

The Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (the OIE Manual) sets out requirements for vaccines against Newcastle disease including safety controls at different stages of the manufacturing process.

(4)

In the interests of safeguarding the health status of poultry in the Union and in order to facilitate trade in poultry and poultry meat, it is appropriate that the requirements for Newcastle disease vaccines and their use in third countries from where poultry and poultry meat may be imported, take into account the requirements for such vaccines set out in the OIE Manual.

(5)

For that purpose, the general criteria for recognised Newcastle disease vaccines set out in Part I of Annex VI to Regulation (EC) No 798/2008 should refer to the requirements of the OIE Manual, which should be kept as a dynamic reference to take into account the regular updates to that Manual in the light of new scientific developments.

(6)

In addition, in view of technical progress that has been made in relation to the production of Newcastle disease vaccines, in particular as regards inactivation techniques, as well as the requirements laid down in the OIE Manual, the specific criteria for inactivated Newcastle disease vaccines set out in point 2 of Part II of Annex VI to Regulation (EC) No 798/2008 should be deleted.

(7)

It is necessary to amend certain provisions for meat of poultry set out in Annex VII to Regulation (EC) No 798/2008 and the corresponding model veterinary certificate for meat of poultry (POU) set out in Annex I, in order to take account of the amendments to Annex VI to that Regulation.

(8)

Regulation (EC) No 798/2008 should therefore be amended accordingly.

(9)

It is appropriate to lay down a date of application of this Regulation, in order to align it with the date of application of Commission Decision 93/152/EEC (3), as amended by Decision 2010/633/EU (4), which introduces corresponding amendments for the criteria for inactivated vaccines against Newcastle disease.

(10)

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

23.10.2010   

EN

Official Journal of the European Union

L 279/10

(1)

Regulation (EC) No 999/2001 lays down rules for the prevention, control and eradication of transmissible spongiform encephalopathies (TSEs) in animals. It applies to the production and placing on the market of live animals and products of animal origin and in certain specific cases to exports thereof.

(2)

Point 4 of Chapter C of Annex X to Regulation (EC) No 999/2001 sets out a list of rapid tests to be used for the monitoring of bovine spongiform encephalopathy (BSE) in bovine animals and TSEs in ovine and caprine animals.

(3)

On 18 December 2009 and 29 April 2010, the European Food Safety Authority (EFSA) published two Scientific Opinions on Analytical sensitivity of approved TSE rapid tests. Those opinions were based on studies performed by the European Union Reference Laboratory (EURL) for TSEs. The EURL studies were intended to evaluate the analytical sensitivity of all the currently approved TSE rapid tests in order to produce robust analytical sensitivity data and evaluate each test against the same sample sets for the three main types of ruminant TSE: BSE, classical scrapie and atypical scrapie.

(4)

As regards scrapie, the EFSA concluded in its opinion published on 18 December 2009 that the tests ‘Enfer TSE v2’, ‘Enfer TSE v3’, ‘Prionics®-Check LIA SR’ and ‘Prionics®-WB Check Western SR’ could fail in identifying atypical scrapie cases that other validated tests would detect and according to the EFSA protocol for evaluation of rapid post mortem tests to detect TSE in small ruminants (EFSA, 2007b) they could not be recommended for use for TSE monitoring in that field. Accordingly, those methods should no longer be included in the list of rapid tests to be used for the monitoring of TSEs in ovine and caprine animals set out in point 4 of Chapter C of Annex X to Regulation (EC) No 999/2001.

(5)

On 2 July 2009, Idexx laboratories informed the Commission that their combined test ‘IDEXX HerdChek BSE-Scrapie Antigen Test Kit, EIA’, which was developed both for the monitoring of TSE in small ruminants and BSE in bovine animals, has never been included in the list of rapid tests to be used for the monitoring of BSE in the Union even though it has been officially approved by the EURL for that purpose. That test should therefore be added to the list of rapid tests for BSE monitoring set out in point 4 of Chapter C of Annex X to Regulation (EC) No 999/2001.

(6)

For practical reasons, the amendments introduced by this Regulation should apply from 1 January 2011, as the Member States need sufficient time in order to align their monitoring procedures for TSEs in ovine and caprine animals with the new list of rapid tests.

(7)

Annex X to Regulation (EC) No 999/2001 should therefore be amended accordingly.

(8)

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

23.10.2010   

EN

Official Journal of the European Union

L 279/13

(1)

Pursuant to Regulation (EC) No 1924/2006 health claims made on food 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 of the application, and to deliver an opinion on a 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)

Two 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 and three opinions are related to applications for health claims referring to children’s development and health, as referred to in Article 14(1)(b) of Regulation (EC) No 1924/2006.

(6)

Following an application from Association de la Transformation Laitière Française (ATLA), submitted pursuant to Article 14(1)(b) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of iodine on normal growth of children (Question No EFSA-Q-2008-324) (2). The claim proposed by the applicant was worded as follows: ‘Iodine is necessary for the growth of children’.

(7)

On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 20 November 2009 that a cause and effect relationship had been established between the intake of iodine 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 Association de la Transformation Laitière Française (ATLA), submitted pursuant to Article 14(1)(b) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of iron on cognitive development of children (Question No EFSA-Q-2008-325) (3). The claim proposed by the applicant was worded as follows: ‘Iron is necessary for the cognitive development of children’.

(9)

On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 20 November 2009 that a cause and effect relationship had been established between the intake of iron 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 the Annex I to the present 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 PremiumTM on reduction of blood cholesterol (Question No EFSA-Q-2009-00454) (4). The claim proposed by the applicant was worded as follows: ‘OPC have been shown to reduce blood cholesterol levels and may therefore reduce the risk of cardiovascular disease’.

(13)

On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 26 October 2009 that a cause and effect relationship had not been established between the intake of OPC PremiumTM 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)

Following an application from Valosun AS, 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 Uroval® on urinary tract infections (Question No EFSA-Q-2009-00600) (5). The claim proposed by the applicant was worded as follows: ‘Cranberry extract and D-mannose, the main active ingredients of the food supplement Uroval®, eliminate the adhesion of harmful bacteria to the bladder wall. The adhesion of harmful bacteria to the bladder wall is the main risk factor in the development of urinary tract infections’.

(15)

On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 22 December 2009 that a cause and effect relationship had not been established between the intake of Uroval® 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.

(16)

Following an application from Töpfer GmbH, submitted pursuant to Article 14(1)(b) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of a combination of bifidobacteria (Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum) on decreasing potentially pathogenic intestinal micro-organisms (Question No EFSA-Q-2009-00224) (6). The claim proposed by the applicant was worded as follows: ‘Probiotic bifidobacteria lead to a healthy intestinal flora comparable to the composition of the intestinal flora of breast-fed infants’ intestine’.

(17)

On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 22 December 2009 that a cause and effect relationship had not been established between the intake of the combination of bifidobacteria 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.

(18)

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.

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

23.10.2010   

EN

Official Journal of the European Union

L 279/18

(1)

Pursuant to Regulation (EC) No 1924/2006 health claims made on food 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 and to deliver an opinion on a 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 Rudolf Wild GmbH & Co. KG, submitted on 10 June 2008 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 Immune Balance Drink on strengthening body’s defences (Question No EFSA-Q-2009-00517) (2). The claim proposed by the applicant was worded, inter alia, as follows: ‘The Immune Balance Drink activates body’s defence’.

(6)

On 4 November 2009, 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 Immune Balance Drink 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)

The comments from the applicant 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.

(8)

Health claims referred to in Article 13(1)(a) of Regulation (EC) No 1924/2006 are subject to the transition measures laid down in Article 28(5) of that Regulation only if they comply with the conditions therein mentioned, among which that they have to comply with the Regulation. As for the claim subject to the present Regulation, the Authority concluded that a cause and effect relationship had not been established between the consumption of the food and the claimed effect and thus it does not comply with the Regulation (EC) No 1924/2006 and it could not benefit from the transition period foreseen in Article 28(5) of that Regulation. A transition period of six months is provided for to enable food business operators to adapt to the requirements laid down in this Regulation.

(9)

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,

23.10.2010   

EN

Official Journal of the European Union

L 279/20

23.10.2010   

EN

Official Journal of the European Union

L 279/22

(1)

European Parliament and Council Directive 95/2/EC on food additives other than colours and sweeteners (3) lays down a list of food additives that may be used in the European Union and the conditions for their use.

(2)

There have been technical developments in the field of food additives since the adoption of Directive 95/2/EC. This Directive should be adapted to take into account those developments.

(3)

In accordance with Article 31 of Regulation (EC) No 1333/2008 until the establishment of the Union lists of food additives as provided for in Article 30 of that Regulation is completed, the Annexes to Directive 95/2/EC shall be amended, where necessary, by measures adopted by the Commission.

(4)

The following stabilisers agar (E 406), carrageenan (E 407), locust bean gum (E 410), guar gum (E 412), xanthan gum (E 415), pectins (E 440), cellulose (E 460), carboxy methyl cellulose (E 466), oxidised starch (E 1404), monostarch phosphate (E 1410), distarch phosphate (E 1412), phosphated distarch phosphate (E 1413), acetylated distarch phosphate (E 1414), acetylated starch (E 1420), acetylated distarch adipate (E 1422), hydroxyl propyl starch (E 1440), hydroxy propyl distarch phosphate (E 1442), starch sodium octenyl succinate (E 1450), acetylated oxidised starch (E 1451) and emulsifier mono- and diglycerides of fatty acids (E 471) are currently authorised under Directive 95/2/EC for a variety of uses. These food additives have been allocated an acceptable daily intake (ADI) ‘not specified’ by the Scientific Committee on Food (hereinafter SCF) and therefore do not present any hazard to the health of consumers. There is a technological need to extend their uses to unflavoured live fermented cream products and substitute products with a fat content of less than 20 % to ensure the stability and integrity of the emulsion. This use would benefit the consumer by providing the choice of reduced fat fermented cream products with similar properties as to the ordinary product. It is therefore appropriate to authorise this additional use.

(5)

In 1990, the SCF evaluated sodium and potassium salts of lactate (E 325 and E 326), potassium acetate (E 261), sodium acetate (E 262i) and sodium hydrogen acetate (E 262ii) and came to the conclusion that they are all naturally present as constituents in food and estimates of their intake are likely to be insignificant compared to the intake from natural sources. Therefore they were all allocated a ‘group ADI not specified’. Consequently, these food additives are generally permitted for use in all foodstuffs, other than those referred to in Article 2(3) of Directive 95/2/EC. There is a proposal to extend the use of these food additives into pre-packed preparations of fresh minced meat to control the growth of microbial pathogens, e.g. Listeria, E. coli O157. Based on this technological justification, and taking into account that this use raises no safety concern, it is appropriate to permit the additional use of these food additives in pre-packed preparations of fresh minced meat.

(6)

Sorbates (E 200, E 202, E 203) and benzoates (E 210, E 211, E 212, E 213) are currently permitted as food additives under Directive 95/2/EC. An additional use as preservative of these food additives is proposed in seaweed-based fish product analogues (caviar analogues made of seaweed) as topping on various foods in order to prevent the growth of moulds and yeasts and the formation of mycotoxins. These salts are allocated an ADI of 0-25 mg/kg bw and 0-5 mg/kg/ bw respectively. On the basis of a worst case scenario where the maximum concentrations were used, the intake estimates are very low compared to the ADI. The exposure of the consumer as a result of this use does not give rise to safety concern. It is therefore appropriate to permit the additional use of sorbates and benzoates in seaweed based fish analogue products, bearing in mind the technological justification and the fact that this new product represents a niche market.

(7)

The use of sorbates (E 200, E 202, E 203) and benzoates (E 210, E 211, E 212, E 213) is requested for beers in keg to which more than 0,5 % fermentable sugars and/or fruit juices or concentrates have been added and which are directly served on draft. These beers in keg may stay connected to the beer tap for a longer time. As the connection of the keg to the tap cannot be performed under sterile conditions, microbiological contamination of the keg is possible. This is a problem for beers which still contain fermentable sugars because this may lead to the growth of hazardous microorganisms. Therefore antimicrobial agents are required in draft beers and to which fermentable sugars and/or fruit juices or concentrates have been added. From an intake point of view, the consumption on draft of such fruit beers remains marginal and the intake estimates for sorbates and benzoates, on the grounds of a ‘worst case approach’, should be below their respective ADIs. Therefore it is appropriate to permit the additional use of sorbates and benzoates in beer in kegs containing more than 0,5 % added fermentable sugar and/or fruit juices or concentrates.

(8)

To prevent the development of moulds on citrus fruit, their post harvest treatment with pesticides such as imazalil and thiabendazole is authorised. Sorbates (E 200, E 202, E 203) could be used to replace these pesticides partly or completely for the treatment of citrus fruit. Sorbates can be applied on the surface of the unpeeled fresh citrus fruit via the authorised waxes: beeswax, candelilla wax, carnauba wax and shellac (E 901, E 902, E 903 and E 904 respectively). The exposure of the consumer to these additives due to this use is not a cause of safety concern. It is therefore appropriate to authorise its additional use.

(9)

Consumers may choose to supplement their intake of some nutrients with food supplements. For that purpose, vitamin A and combinations of vitamins A and D can be added to food supplements, as defined by Directive 2002/46/EC of the European Parliament and of the Council (4). For reasons of safe handling, vitamin A and combinations of vitamins A and D have to be formulated into preparations that may require high humidity and high temperature, in the presence of starches and sugars. Such processing may favour the development of microorganisms. In order to prevent the growth of these microorganisms, the addition of sorbates (E 200, E 202, E 203) and benzoates (E 210, E 211, E 212 and E 213) should be authorised in vitamin A and in combinations of vitamins A and D when used in food supplements supplied in dried form.

(10)

Sulphur dioxide and sulphites (E 220, E 221, E 222, E 223, E 224, E 226, E 227, E 228) are food additives authorised under Directive 95/2/EC which act primarily as antimicrobial agents and controlling chemical spoilage. Nowadays, transport of fresh fruit has become very important, in particular by sea freight. Such transport may be several weeks. The use of sulphur dioxide and sulphites will protect fresh blueberries against fungi growth. The additional use of sulphur dioxide and sulphites should be authorised in order to help preserve fresh blueberries against fungi growth, bearing in mind that this is likely to represent a niche market. Taking also into consideration the sound technological reasons for including these new authorisations, the need to facilitate worldwide trade and its negligible impact in term of sulphur and sulphite intake, it is therefore appropriate to authorise the additional use of sulphur dioxide in blueberries at the concentration level indicated in the Annex to this Directive.

(11)

For the production of cinnamon sticks (Cinnamomum ceylanicum only), also known as ‘quills’, the fresh peels of the inner bark of the cinnamon tree is used. The peel is exposed to microbial contamination and insect attacks, particularly under tropical and humid climatic conditions, in the producing country. Sulphur dioxide fumigation is an appropriate treatment against such microbial contamination and insect attacks. In 1994, the SCF established an ADI of 0-0,7 mg/kg bw and considered that the use of sulphur dioxide and other sulphiting agents should be limited in order to limit the occurrence of severe asthmatic reactions. Although the use of sulphur dioxide and sulphites should be limited, this specific use represents a negligible contributor in relation to the intake of sulphur dioxide and sulphites. It is therefore appropriate to authorise the additional use of sulphur dioxide and sulphites (E 220, E 221, E 222, E 223, E 224, E 226, E 227, E 228) only in this particular type of cinnamon.

(12)

The European Food Safety Authority (hereinafter EFSA) assessed the information on the safety of use of nisin in an additional food category of liquid eggs, and on the safety of nisin produced using a modified production process. The EFSA confirmed in its opinion on 26 January 2006 (5) the previously established ADI of 0-0,13 mg/kg for the nisin produced using a new manufacturing and extraction process based on fermentation of a sugar medium as a replacement for the traditionally milk-based medium. In this opinion, the EFSA also confirmed that the development of antibiotic resistance should not be expected from the use of nisin in food. According to the EFSA, there are no reports of nisin resistant bacterial mutants showing cross-resistance to therapeutic antibiotic. It considered that this is probably due to the differences between therapeutic antibiotics and nisin in terms of the antimicrobial mode of action. The EFSA furthermore confirmed in its opinion issued on 20 October 2006 (6) that the additional use of nisin in pasteurised liquid eggs under the intended conditions of use (maximum limit at 6,25 mg/l) is not a safety concern and is justified from a technological point of view to extend the shelf life of the product and also to prevent the growth of food poisoning spore-forming species, like Bacillus cereus, which may survive from pasteurisation treatment. It is therefore appropriate to authorise this additional use of nisin in pasteurised liquid egg.

(13)

Dimethyl dicarbonate (DMDC, E 242) is a food additive permitted under Directive 95/2/EC which acts as a preservative in non-alcoholic flavoured drinks, alcohol-free wine and liquid-tea concentrate. The authorisation of this additive was decided on the basis of a positive opinion issued by the SCF in 1990 and confirmed in 1996. The SCF was unable to set an ADI, as DMDC rapidly decomposes into carbon dioxide and methanol. In 2001, the SCF was requested to investigate the safety of use of DMDC in wine. At that time the SCF considered that the formation of methanol and other reaction products, such as methylcarbamate resulting from the use of DMDC for the treatment of alcoholic beverages and wine is similar to that formed in non-alcoholic beverages, and even a heavy consumption of wine would not pose any hazard from methanol and methylcarbamate. The use of DMDC has been requested in order to prevent spoilage as a result of fermentation in unopened non-sterile filled bottles of cider, perry and fruit wines, alcohol-reduced wine, wine-based drinks and all other products covered by Council Regulation (EEC) No 1601/91 (7). These additional uses are not considered as being of safety concern for the consumer. Moreover, the use of DMDC could contribute to the reduction of the sulphur dioxide exposure. It is therefore appropriate to authorise the additional uses of DMDC in cider, perry and fruit wines, alcohol-reduced wine, wine-based drinks and other products covered by Regulation (EEC) No 1601/91.

(14)

The EFSA assessed the information on the safety of use of extracts of rosemary when used as an antioxidant in foodstuffs. Extracts of rosemary are derived from Rosmarinus officinalis L. and contain several compounds which exert antioxidative functions (mainly phenolic acids, flavonoids, diterpenoids and triterpenes). Although the toxicological data on extracts of rosemary were insufficient for the EFSA to establish a numerical ADI, the EFSA considered in its opinion on 7 March 2008 (8) that the margin of safety was high enough to conclude that dietary exposure resulting from the proposed uses and use levels were of no safety concern. Extracts of rosemary can therefore be authorised where there is a technological justification for their use. The proposed uses of extracts of rosemary as antioxidant should be authorised and E 392 should be assigned as E number for extracts of rosemary.

(15)

Whey is a by-product of cheese manufacturing. Some whey protein containing drinks have been developed in order to provide a diet sufficiently rich in proteins. To keep the proteins in suspension during the heat treatment of such drinks, the phosphates must be at levels that are higher than for normal non-alcoholic flavoured drinks. Phosphates should be authorised in whey protein containing sport drinks.

(16)

Beeswax (E 901) is currently authorised as a glazing agent for use in small products of fine bakery wares coated with chocolate. This authorisation does not cover ice cream wafers that are not coated with chocolate. In addition to the fact that beeswax can be considered as an alternative to chocolate in pre-packed ice cream wafers, the coating of the wafers with beeswax would prevent the migration of water to the wafer and ensure its crunchiness and the extension of the shelf life of the product and is therefore considered technologically justified. Therefore beeswax should be authorised as a glazing agent to replace fully or partly the in-layer chocolate in pre-packed wafers containing ice-cream.

(17)

The EFSA assessed the information on the safety of use of beeswax considering its additional use as a carrier of flavourings in non-alcoholic flavoured drinks. Although the available data on beeswax itself were insufficient to establish an ADI, the EFSA came to the conclusion that, due to the low toxicological profile of beeswax, the existing food uses and the proposed new use of beeswax do not raise safety concern. It is therefore appropriate to authorise this additional use of beeswax as a carrier of flavourings in non-alcoholic flavoured drinks.

(18)

Triethyl citrate (E 1505) is currently authorised within the EU under Directive 95/2/EC as a carrier in flavourings, and in dried egg white. Its ADI was established by the SCF in 1990 at 0-20 mg/kg. An extension of use of triethyl citrate has been proposed as glazing agent of food supplement tablets. Triethyl citrate would increase the film resistance of the coating, protecting the tablet from external environment and also increase the duration of release of the product. According to the worst case scenario, this additional source of triethyl citrate intake is negligible (0,25 % of the ADI) compared to the full ADI. Therefore it is appropriate to authorise the additional use of triethyl citrate at EU level as a glazing agent for food supplement tablets.

(19)

The EFSA assessed the information on the safety of polyvinyl alcohol (PVA) as a film-coating agent for food supplements and expressed its opinion on 5 December 2005 (9). The EFSA found the use of PVA in the coating of food supplements that are in the form of capsules and tablets to be of no safety concern. The EFSA considered that the potential human exposure to PVA under the intended conditions of use is expected to be low. PVA is reported to be minimally absorbed following oral administration. The maximum limit of use has been fixed at 18 g/kg based on the worst case scenario and on the basis of which the EFSA has undertaken its risk assessment. Due to the good adhesion qualities and film strength of polyvinyl alcohol, this new food additive is expected to play a technological role as film coating agent for food supplements, in particular in applications where moisture barrier and moisture protection properties are required. It is therefore appropriate to authorise this use at EU level. This new food additive should be assigned the E number E 1203.

(20)

The EFSA assessed the information on the safety of use of six grades of polyethylene glycols (PEG 400, PEG 3000, PEG 3350, PEG 4000, PEG 6000, PEG 8000) as film coating agents for use in food supplement products and expressed its opinion on 28 November 2006 (10). The EFSA found the use of these grades of polyethylene glycol as a glazing agent in film-coating formulations for food supplement tablets and capsules under the intended conditions of use of no safety concern. The EFSA has also taken into consideration in its risk assessment the additional source of exposure to these PEGs originating from the use of pharmaceutical products and considered that only a limited additional intake may result from the already approved use of PEG 6000 as carrier for sweeteners, as well as from the use of PEG in food contact materials. It is therefore appropriate to authorise this new use at EU level. In addition, due to the limited intake from PEG 6000 as carrier of sweeteners and its similar toxicological profile with respect to the other PEG grades (the six PEGs have been allocated a group tolerable daily intake (TDI), it is also appropriate to authorise the use of the PEGs evaluated by the EFSA as an alternatives to PEG 6000 as carrier of sweeteners. All these PEGs should be assigned E 1521 as E number.

(21)

The EFSA assessed the information on the safety of use of cassia gum as a new food additive acting as gelling agent and thickener and expressed its opinion on 26 September 2006 (11). The EFSA found the use of cassia gum as indicated under the conditions specified raised no safety concern. Although the EFSA considered the available toxicological data on cassia gum as insufficient to derive an ADI, they did not consider that the existing data gave cause for concern. In particular the EFSA highlighted the specific low absorption of cassia gum and the fact that, if hydrolysed at all, cassia gum would be degraded to compounds that will enter the normal metabolic pathways. There is a technological justification for the use of cassia gum through its synergistic gelling effects when added to other regular food gums. It is therefore appropriate to authorise these uses at EU level and to assign E 427 as E number for cassia gum.

(22)

The EFSA evaluated the safety of neotame as a flavour enhancer and expressed its opinion on 27 September 2007 (12). The EFSA concluded that neotame is of no safety concern with respect to the proposed uses as a flavour enhancer and established an ADI of 0-2 mg/kg bw/day. Therefore it is necessary to authorise the use of neotame as a flavour enhancer.

(23)

The EFSA assessed the information on the safety of use of L-cysteine (E 920) in certain foodstuffs intended for infants and young children. The EFSA concluded in its opinion on 26 September 2006 (13) that its proposed use in processed cereal-based foods and foods (specifically baby biscuits) for infants and young children is of no safety concern. Biscuits for infants and young children are required to have a suitable composition, including a controlled content of sugar and fat. However, biscuits with a low fat content have increased brittleness with an associated risk of choking and suffocation due to the biscuit breaking in the child’s mouth. The function of the L-cysteine is to act as a dough improver to control the texture of the final product. It is therefore appropriate to authorise the use of L-cysteine in biscuits for infants and young children at EU level.

(24)

EFSA assessed the safety of use of an enzyme preparation based on thrombin with fibrinogen derived from cattle and/or pigs as a food additive for reconstituting food and concluded in its opinion on 26 April 2005 that this use of the enzyme preparation when produced as outlined in the opinion is of no safety concern (14). However, the European Parliament in its Resolution of 19 May 2010 on the draft Commission Directive amending the Annexes to the European Parliament and Council Directive 95/2/EC on food additives other than colours and sweeteners, considered that the inclusion in Annex IV to Directive 95/2/EC of this enzyme preparation as a food additive for reconstituting food was not compatible with the aim and content of Regulation (EC) No 1333/2008, as it does not meet the general criteria of Article 6 of Regulation (EC) No 1333/2008, especially in paragraph 1(c) of Article 6.

(25)

Commission Decision 2004/374/EC (15) suspended the placing on the market and import of jelly mini-cups containing gel-forming food additives derived from seaweed and certain gums (E 400, E 401, E 402, E 403, E 404, E 405, E 406, E 407, E 407a, E 410, E 412, E 413, E 414, E 415, E 417, E 418) due to the risk of choking posed by these products. Directive 95/2/EC was amended accordingly by Directive 2006/52/EC of the European Parliament and of the Council (16). Commission Decision 2004/374/EC should therefore be repealed as its provisions have been included in Directive 95/2/EC.

(26)

The measures provided for in this Directive 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 has opposed them,

23.10.2010   

EN

Official Journal of the European Union

L 279/32

(1)

The term of office of the members of the European Economic and Social Committee expired on 20 September 2010.

(2)

On 13 September 2010, the Council adopted Decision 2010/570/EU, Euratom appointing the members of the European Economic and Social Committee for the period from 21 September 2010 to 20 September 2015 (1), except for one Romanian member, whom the Romanian authorities reserved the right to nominate at a later stage.

(3)

By a letter which reached the Council on 28 September 2010, the Romanian authorities proposed to the Council a candidate for appointment as a member of the European Economic and Social Committee during the abovementioned period, in order to complete the list of members allocated to Romania by the Treaty,

23.10.2010   

EN

Official Journal of the European Union

L 279/33

(1)

Commission Decision 93/152/EEC (2) lays down certain rules concerning the vaccines to be used in routine vaccination programmes against Newcastle disease.

(2)

In particular, that Decision sets out the criteria that have to be met for the intracerebral pathogenicity index (ICPI) in respect of the Newcastle disease virus strain used in live attenuated and inactivated vaccines against that disease.

(3)

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (3) provides for certain requirements for immunological veterinary medicinal products, including requirements for safety tests.

(4)

In view of the technical progress which has been made in relation to the manufacture of vaccines, in particular as regards inactivation techniques and the requirements of Directive 2001/82/EC and the European Pharmacopoeia, it is therefore appropriate to delete the specific requirement for inactivated vaccines regarding the intracerebral pathogenicity index (ICPI) in respect of the Newcastle disease virus strain used in such vaccines currently laid down in point (b) of Article 1 of Decision 93/152/EEC.

(5)

Decision 93/152/EEC should therefore be amended accordingly.

(6)

It is appropriate to lay down a date of application of this Decision, in order to align it with the date of application of Commission Regulation (EC) No 798/2008 (4), as amended by Regulation (EU) No 955/2010 (5), which introduces corresponding amendments for the criteria for inactivated vaccines against Newcastle disease used in third countries,

23.10.2010   

EN

Official Journal of the European Union

L 279/34

(1)

In accordance with Article 9a of Directive 2003/87/EC, the Union-wide quantity of allowances should be adjusted to reflect allowances issued in respect of installations that were included in the EU Emission Trading Scheme during the period from 2008 to 2012 pursuant to Article 24(1) of Directive 2003/87/EC. The Union-wide quantity of allowances should also be adjusted in respect of installations that carry out activities listed in Annex I to the Directive and that are only included in the Union scheme from 2013 onwards.

(2)

In accordance with Article 9 of Directive 2003/87/EC, Commission Decision 2010/384/EU of 9 July 2010 on the Community-wide quantity of allowances to be issued under the EU Emission Trading Scheme for 2013 (2) based the absolute Union-wide quantity of allowances for 2013 on the total quantities of allowances issued or to be issued by the Member States in accordance with the Commission decisions on their national allocation plans for the period from 2008 to 2012. As additional information has become available since the adoption of that Decision, it should be repealed and replaced.

(3)

Further to applications by Member States for the unilateral inclusion of additional activities and gases in the Union scheme under Article 24(1) of Directive 2003/87/EC, activities previously not included in the Union scheme were included in the scheme by Commission Decisions C(2008) 7867, C(2009) 3032 and C(2009) 9849. For the purpose of this Decision, applications pursuant to Article 24(1) of Directive 2003/87/EC should be taken into account where the Commission has approved their inclusion before 31 August 2010. It will remain possible to reflect in future adjustments to the Union-wide quantity of allowances for 2013 inclusions approved by the Commission after this date. Pursuant to Article 9a(1) of Directive 2003/87/EC, the Union-wide quantity of allowances is to be adjusted by the linear factor referred to in Article 9 of the Directive from 2010 onwards.

(4)

In accordance with Article 2(1) of Directive 2009/29/EC of the European Parliament and of the Council of 23 April 2009 amending Directive 2003/87/EC so as to improve and extend the greenhouse gas emission allowance trading scheme of the Community (3) Member States have brought into force national law, regulations and administrative provisions to ensure that the operators of installations carrying out activities listed in Annex I to Directive 2003/87/EC that are only included in the Union scheme from 2013 onwards, were able to submit to the relevant competent authority duly substantiated and independently verified emissions data. Such data is necessary, if it is to be taken into account for the adjustment of the Union-wide quantity of allowances. Member States were required to notify duly substantiated emission data to the Commission by 30 June 2010.

(5)

To provide a level playing field for all installations, emissions data notified by Member States to the Commission should be adjusted to take into account the emission reduction effort that would have been expected from installations only included in the Union scheme as from 2013, had they been included in the Union scheme as from 2005. The Union-wide quantity of allowances is also to be adjusted pursuant to Article 9a(2) of the Directive by the linear factor referred to in Article 9 of the Directive from 2010 onwards. In the event that new Member States join the Union, it will remain possible to reflect additional information in future adjustments to the Union-wide quantity of allowances.

(6)

Where Member States notified emissions from installations producing ammonia or soda ash, which will only be included in the Union scheme as from 2013, emissions serving as the basis for the calculation of the adjustment of the Union-wide quantity of allowances determined in this Decision, were taken into account assuming that these emissions represent emissions in the sense of Article 3(b) of Directive 2003/87/EC. To guarantee consistency between the total quantity of allowances in the Union scheme, and the emissions for which allowances have to be surrendered, it will remain possible to revise the Union-wide quantity of allowances, if the Regulation to be adopted pursuant to Article 14(1) of Directive 2003/87/EC deviates from this approach.

(7)

To avoid double counting, only notified emissions with respect to activities listed in Annex I to Directive 2003/87/EC included in the scope of the Union scheme as from 2013, should be taken into account for the adjustment of the Union-wide quantity of allowances.

(8)

Pursuant to Article 27 of Directive 2003/87/EC, Member States may exclude certain installations from the Union-wide scheme, if they notify the Commission of each of those installations by not later than 30 September 2011 and the Commission does not object. To date, the Commission has not received notifications from Member States in this respect. It will remain possible to reflect such exclusions in future adjustments to the Union-wide quantity of allowances for 2013.

(9)

It may be necessary to take into account additional information concerning the Union-wide quantity of allowances pursuant to Article 9 of Directive 2003/87/EC, as determined by Decision 2010/384/EU when it becomes available. It will remain possible to reflect such additional information in future adjustments to the Union-wide quantity of allowances for 2013.

(10)

On the basis of information available since the adoption of Decision 2010/384/EU, the average annual total quantity of allowances issued by Member States in accordance with the Commission decisions on their national allocation plans for the period from 2008 to 2012, which is taken into account for the calculation of the Union-wide quantity of allowances pursuant to Article 9 of Directive 2003/87/EC amounts to 2 037 227 209.

(11)

For 2013, the absolute Union-wide quantity of allowances referred to in Article 9 of Directive 2003/87/EC amounts to 1 930 883 949.

(12)

For 2013, the quantity of allowances issued in respect of installations that were included in the Union scheme during the period from 2008 to 2012 pursuant to Article 24(1) of Directive 2003/87/EC and adjusted by the linear factor referred to in Article 9 of this Directive amounts to 1 328 218.

(13)

For 2013, the quantity of allowances issued in respect of installations that are included in the Union scheme from 2013 onwards and adjusted by the linear factor referred to in Article 9 of this Directive amounts to 106 940 715.

(14)

On the basis of Article 9 and Article 9a, the total quantity of allowances to be issued from 2013 onwards is to annually decrease by a linear factor of 1,74 %, amounting to 37 435 387 allowances,

23.10.2010   

EN

Official Journal of the European Union

L 279/36

(1)

Article 37 requires that each Member State is to provide the Commission with such general data relating to any plan for the disposal of radioactive waste in whatever form as will make it possible to determine whether the implementation of such plan is liable to result in the radioactive contamination of the water, soil or airspace of another Member State. The Commission is to deliver its opinion within six months, after consulting the group of experts referred to in Article 31.

(2)

Experience has been acquired in the application of the Commission Recommendations of 16 November 1960 (1), 82/181/Euratom (2) 91/4/Euratom (3) and 1999/829/Euratom (4) concerning the application of Article 37 of the Treaty.

(3)

The Court of Justice of the European Union, in its judgment of 22 September 1988 in Case 187/87 (5), ruled that Article 37 of the Euratom Treaty must be interpreted as meaning that the European Commission shall be provided with general data before the discharge authorisation of radioactive effluents is granted by the Member State concerned, in order to make it possible for the Commission to issue its opinion before such discharges are authorised so that the Commission’s opinion can be taken into account.

(4)

Article 37 has as its objective to forestall any possibility of radioactive contamination of another Member State. The Commission, having consulted the abovementioned group of experts has deemed the disposal of radioactive waste associated with certain operations not to be liable to result in the radioactive contamination of another Member State.

(5)

In exceptional cases due to information received, the Commission may call for general data to be submitted for a plan for the disposal of radioactive waste, otherwise deemed not to be liable to result in the radioactive contamination of another Member State on the basis of the present Recommendation; the Commission’s opinion may then pertain to an authorisation which has been granted at an earlier stage.

(6)

To appraise disposal plans in a consistent manner, it is necessary to specify which types of operation may result in the disposal of radioactive waste within the meaning of Article 37 of the Treaty, and to specify for the different types of operation which information is to be supplied as the general data.

(7)

Mixed-oxide fuel fabrication plants process large amounts of plutonium oxide, a submission of general data for the dismantling of such plants should be required as is already the case for the dismantling of nuclear reactors and reprocessing plants.

(8)

Trivial operations having no or negligible radiological impact in other Member States should not be submitted to the Commission.

(9)

Member States may communicate an integrated submission for a complex site where major changes are scheduled to be carried out over a long period of time, involving several steps and including the operation of new facilities, and the completeness of the information contained in the initial general data should allow the Commission to fulfil its obligations pursuant to Article 37 of the Euratom Treaty and deliver a sound opinion.

(10)

In view of the number of existing nuclear plants on which no opinion has already been issued within the meaning of Article 37 of the Treaty and which may be subject to modifications or dismantling operations, it is necessary to specify which information is to be supplied as the general data to allow the Commission to fulfil its obligation without prejudice to the principle of equity between installations subject to modifications and those which are not.

(11)

In cases where the exposure of the population in the vicinity of the site of interest is very low, this information may be sufficient for the assessment of the impact on other Member States.

(12)

To appraise in a consistent manner the radiological impact on other Member States of accidental situations, information requested in the general data on unplanned releases from nuclear reactors and reprocessing plants should be extended beyond the reference accidents to accidents taken into consideration for the establishment of the site related national emergency plan.

(13)

To clarify and limit the information required by the Commission pertaining to the predisposal management of radioactive waste and to modifications of a plan on which no opinion has already been issued by the Commission, two new annexes have been included.

(14)

All Member States have now declared that they will desist from sea dumping and no Member State intends to carry out sub-seabed burial of radioactive waste,

1.

The ‘disposal of radioactive waste’ within the meaning of Article 37 of the Treaty should cover any planned or accidental release of radioactive substances associated with the operations listed below, in gaseous, liquid or solid form in or to the environment:

2.

‘General data’ within the meaning of Article 37 of the Treaty should be understood to mean:

3.

Operations falling within the scope of point 1(12) should be deemed not to be liable to result in the radioactive contamination of another Member State, significant from the point of view of health, unless in any specific case the Commission calls for general data to be provided.

4.

For operations falling within the scope of point 1(9), the submission of general data should be governed by the following conditions:

5.

If a Member State envisages modifying (10) a plan for the disposal of radioactive waste, the submission of general data should be governed by the following conditions:

6.

The general data should be submitted to the Commission:

7.

Where Member States communicate an integrated submission of general data for a complex site where major changes are scheduled to be carried out over long periods of time, involving several steps and including, inter alia, the operation of new facilities, the initial submission should contain a complete and detailed overview of the planned operations, to be updated by subsequent submissions in case of any modifications to the existing plan. As regards the accident scenarios in the initial submission, the general data should include at least information on estimated amounts and physico-chemical forms of radionuclides present in each of the facilities on the site as well as quantities assumed to be released in the event of the accident considered for each of those facilities. The general data may provide background on past and current operations on the site, bearing in mind that the Commission’s opinions will relate only to future operations.

8.

Since submission of a plan for the disposal of radioactive waste is the responsibility of the relevant Member State, that State should accept responsibility for all information submitted to the Commission in respect of such a plan.

9.

Following receipt of an opinion, the Member State concerned should inform the Commission of the actions it envisages in response to any recommendation given in the Commission opinion on a disposal plan.

10.

Following receipt of an opinion, the Member State concerned should communicate to the Commission the discharge authorisation as well as any later amendments for comparison with the information in the general data on which the Commission opinion was based.