29.8.2013   

EN

Official Journal of the European Union

L 230/1

(1)

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

(2)

Commission Regulation (EU) No 231/2012 (3) lays down specifications for food additives including colours and sweeteners that are listed in Annexes II and III to Regulation (EC) No 1333/2008.

(3)

Those lists may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application.

(4)

Applications for authorisation of the use of Anionic methacrylate copolymer and Neutral methacrylate copolymer as glazing agents in solid food supplements were submitted on 25 and 27 April 2009 and were made available to the Member States.

(5)

The European Food Safety Authority evaluated the safety of Neutral methacrylate copolymer (4) and Anionic methacrylate copolymer (5) when used as food additives and concluded that their use in solid food supplements at the proposed use levels is not of a safety concern.

(6)

There is a technological need for the use of Neutral methacrylate copolymer and Anionic methacrylate copolymer in solid food supplements. Neutral methacrylate copolymer is intended to be used as a sustained-release glazing agent. Sustained-release formulations allow the continuous dissolution of a nutrient over a defined time. Anionic methacrylate copolymer is intended to be used as a glazing agent to protect the stomach against irritating ingredients and/or to protect sensitive nutrients against disintegration by the gastric acid. It is therefore appropriate to authorise the use of both food additives in solid food supplements and to assign E 1206 as E-number to Neutral methacrylate copolymer and E 1207 as E-number to Anionic methacrylate copolymer.

(7)

Commission Regulation (EU) No 1129/2011 (6) authorised the use of Basic methacrylate copolymer (E 1205) in solid food supplements and Regulation (EU) No 231/2012 sets out the specifications for that food additive, including the maximum levels for arsenic, lead, mercury and copper. Those specifications should be updated to take into account the maximum levels for lead, mercury and cadmium in food supplements as set out in Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (7).

(8)

Maximum level of arsenic in food supplements has not been set at the Union level. However, specific levels are laid down in the laws of Member States. Therefore, it is appropriate to update specifications of Basic methacrylate copolymer (E 1205) in Regulation (EU) No 231/2012 as regards arsenic to take into account the laws of Member States.

(9)

Maximum level of copper in food supplements has not been set at the Union level and there is no indication of copper presence at toxicologically significant levels in Basic methacrylate copolymer (E 1205). It is therefore appropriate to delete copper from the purity section for Basic methacrylate copolymer (E 1205) in Regulation (EU) No 231/2012.

(10)

Specifications should be adopted for Neutral methacrylate copolymer (E 1206) and Anionic methacrylate copolymer (E 1207). The purity criteria for arsenic, lead, mercury and cadmium should follow the same approach as those for Basic methacrylate copolymer (E 1205) and the maximum levels should take into account that the commercial form of Neutral methacrylate copolymer (E 1206) and Anionic methacrylate copolymer (E 1207) is a 30 % dispersion of the dry substance in water.

(11)

Regulation (EC) No 1333/2008 and Regulation (EU) No 231/2012 should therefore be amended accordingly.

(12)

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

29.8.2013   

EN

Official Journal of the European Union

L 230/7

(1)

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

(2)

Annex III to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food additives, food enzymes, flavourings, nutrients and their conditions of use.

(3)

Commission Regulation (EU) No 231/2012 (3) lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008.

(4)

Those lists and the specifications may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 either on the initiative of the Commission or following an application.

(5)

An application for authorisation of the use of Octenyl succinic acid modified gum arabic as an emulsifier in certain food categories and in flavourings was submitted on 12 November 2007 and has been made available to the Member States.

(6)

The European Food Safety Authority evaluated the safety of octenyl succinic acid modified gum arabic, as emulsifier to be added to flavourings and certain other foodstuffs and expressed its opinion on 11 March 2010 (4). The Authority concluded that, based on the results of the available studies, the information on gum acacia itself and on other Octenyl succinic acid modified starches, the use of octenyl succinic acid modified gum arabic as an emulsifier in foods at the proposed uses and use levels is not of a safety concern.

(7)

There is a technological need to use Octenyl succinic acid modified gum arabic as an emulsifier in certain foodstuffs as well as an emulsifier in flavouring-oil emulsions which are added to a variety of foodstuffs as it has improved properties compared to existing emulsifiers. It is therefore appropriate to authorise the use of octenyl succinic acid modified gum arabic in the food categories applied for and to assign number E 423 to that food additive.

(8)

The specifications for Octenyl succinic acid modified gum arabic should be included in Regulation (EU) No 231/2012 when it is included in the Union lists of food additives laid down in Annexes II and III to Regulation (EC) No 1333/2008 for the first time.

(9)

Regulation (EC) No 1333/2008 and Regulation (EU) No 231/2012 should therefore be amended accordingly.

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

29.8.2013   

EN

Official Journal of the European Union

L 230/12

(1)

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

(2)

That list may be amended in accordance with the common procedure referred to in Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2).

(3)

Pursuant to Article 3(1) of Regulation (EC) No 1331/2008, the Union list of food additives may be updated either on the initiative of the Commission or following an application.

(4)

An application for authorisation of the use of Sucrose esters of fatty acids (E 473) as an emulsifier in flavourings was submitted on 20 August 2008 and has been made available to the Member States.

(5)

Emulsifiers are needed to stabilise oily flavourings when these are added in water based beverages. Without the addition of an emulsifier the flavouring oil would not be soluble and would appear on the surface of the beverage as an oily ring. This prevents the even dispersal of the flavouring through the beverage and increases its exposure to oxygen, leading to reduced organoleptic acceptability. It also makes the development of clear beverages extremely difficult. These issues can be overcome to some extent with the use of washed oils, however those have reduced organoleptic acceptability. The use of Sucrose esters of fatty acids enables clear beverages with improved functionality of the added flavouring.

(6)

Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the European Food Safety Authority in order to update the Union list of food additives set out in Annex III to Regulation (EC) No 1333/2008.

(7)

The European Food Safety Authority issued an opinion on sucrose esters of fatty acids (E 473) and established an Acceptable Dalily Intake of 40 mg/kg bw/day (3). The exposure to sucrose esters of fatty acids resulting from the additional proposed use in clear flavoured soft drinks represents less than 0,1% of the ADI (4). Taking into account that the exposure due to the additional use of this additive is negligible compared to the ADI, this additional use of Sucrose esters of fatty acids (E 473) is not liable to have an effect on human health.

(8)

It is therefore appropriate to authorise the use of Sucrose esters of fatty acids (E 473) as a food additive in flavourings for water based clear flavoured drinks.

(9)

Therefore, Annex III to Regulation (EC) No 1333/2008 should be amended accordingly.

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

29.8.2013   

EN

Official Journal of the European Union

L 230/14

(1)

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

(2)

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

29.8.2013   

EN

Official Journal of the European Union

L 230/16

(1)

Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (2) lays down, inter alia, compositional and labelling rules for infant formulae and follow-on formulae.

(2)

Directive 2006/141/EC specifically provides for infant formulae and follow-on formulae to only be manufactured from protein sources defined in that Directive. Those protein sources are cows’ milk proteins and soya protein isolates, alone or in a mixture, as well as protein hydrolysates.

(3)

On request from the Commission, the European Food Safety Authority delivered, on 28 February 2012, a scientific opinion on the suitability of goat milk protein as a source of protein in infant formulae and in follow-on formulae. That opinion concluded that protein from goats’ milk can be suitable as a protein source for infant formulae and follow-on formulae provided that the final product complies with the compositional criteria laid down in Directive 2006/141/EC.

(4)

On the basis of that opinion, infant formulae and follow-on formulae manufactured from goats’ milk proteins should be allowed on the market provided that the final product complies with the compositional criteria laid down in Directive 2006/141/EC. Directive 2006/141/EC should therefore be amended accordingly.

(5)

On request from the Commission, the European Food Safety Authority delivered, on 5 October 2005, a scientific opinion on the safety and suitability for particular nutritional use by infants of formula based on whey protein partial hydrolysates with a protein content of at least 1,9 g/100 kcal, which was below the minimum level provided for in the Union legislation at that time. That opinion concluded that infant formula, based on hydrolysates of whey protein derived from cows’ milk with a protein content of 1,9 g/100 kcal (0,47 g/100 kJ) and corresponding to the protein formulation assessed, is safe and suitable for use as the sole source of nutrition of infants. On the basis of that opinion, Directive 2006/141/EC, as amended by Commission Regulation (EC) No 1243/2008 of 12 December 2008 amending Annexes III and VI to Directive 2006/141/EC as regards compositional requirements for certain infant formulae (3), authorises the marketing of infant formulae manufactured from protein hydrolysates with such a protein content provided that the product complies with certain specific criteria set out therein.

(6)

That opinion also concluded that, while no data on follow-on formulae based on hydrolysed whey protein with a protein content of 1,9 g/100 kcal (0,47 g/100 kJ) had been submitted, a formula with that protein formulation would be suitable for older infants in conjunction with complementary foods.

(7)

On the basis of that opinion, and in order to allow the development of innovative products, such follow-on formulae should be allowed on the market. Directive 2006/141/EC should therefore be amended accordingly.

(8)

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 have opposed them,

(1)

Article 7 is amended as follows:

(2)

in Article 12, the introductory phrase is replaced by the following:

‘The name under which infant formulae and follow-on formulae manufactured entirely from cows’ milk or goats’ milk proteins are sold shall be respectively:’;

(3)

Annexes I, II, III and VI are amended in accordance with the Annex to this Directive.

29.8.2013   

EN

Official Journal of the European Union

L 230/20

(1)

Avian influenza is an infectious viral disease in birds, including poultry. Infections with avian influenza viruses in domestic poultry cause two main forms of that disease that are distinguished by their virulence. The low pathogenic form generally only causes mild symptoms, while the highly pathogenic form results in very high mortality rates in most poultry species. That disease may have a severe impact on the profitability of poultry farming.

(2)

Avian influenza is mainly found in birds, but under certain circumstances infections can also occur in humans even though the risk is generally very low.

(3)

In the event of an outbreak of avian influenza, there is a risk that the disease agent might spread to other holdings where poultry or other captive birds are kept. As a result it may spread from one Member State to other Member States or to third countries through trade in live birds or their products.

(4)

Council Directive 2005/94/EC (3) sets out certain preventive measures relating to the surveillance and the early detection of avian influenza and the minimum control measures to be applied in the event of an outbreak of that disease in poultry or other captive birds. That Directive provides for the establishment of protection and surveillance zones in the event of an outbreak of highly pathogenic avian influenza.

(5)

Council Directive 2009/158/EC (4) lays down rules for trade within the Union in those commodities, including the veterinary certificates to be used.

(6)

Following the notification by Italy of an outbreak of highly pathogenic avian influenza of subtype H7N7 in a holding in the commune of Ostellato, in the province of Ferrara in the Region Emilia-Romagna on 15 August 2013, the Commission adopted Implementing Decision 2013/439/EU (5), that lays down provisions for protection and surveillance zones to be established around the outbreak.

(7)

On 21 August 2013 Italy notified the occurrence of a second outbreak of disease in the commune of Mordano in the province of Bologna and on 23 August 2013 of a third outbreak of disease in the commune of Portomaggiore in the province of Ferrara, both in the Region Emilia-Romagna and it immediately took the measures required pursuant to Directive 2005/94/EC, including the establishment of protection, surveillance and further restricted zones, which should be defined in Parts A, B and C of the Annex to this Decision.

(8)

The Commission has examined those measures in collaboration with Italy, and it is satisfied that the borders of those zones established by the competent authority in that Member State are at a sufficient distance to the actual holding where the outbreak was confirmed.

(9)

In order to prevent any unnecessary disturbance to trade within the Union and to avoid unjustified barriers to trade being imposed by third countries, it is necessary to rapidly define those zones established in Italy at Union level and to provide that no consignments of live poultry, ready-to-lay poultry, day-old chicks and hatching eggs are dispatched from those zones to other Member States or to third countries.

(10)

Day-old chicks present a negligible risk for the spread of the disease provided that in accordance with the provisions of Article 30(c)(iii) second subparagraph of the Directive 2005/94/EC they have hatched from hatching eggs originating from poultry holdings located outside the protection and surveillance zones and the hatchery of dispatch can ensure by its logistics and by its biosecurity working conditions that no contact has occurred between those eggs and any other hatching eggs or day-old chicks originating from poultry flocks within the established protection or surveillance zones and which are therefore of a different health status.

(11)

Hatching eggs equally present a negligible risk for the spread of the disease provided that in accordance with the provisions of Article 30(c)(iv) of Directive 2005/94/EC they originate from holdings located outside the protection and surveillance zones and their packaging is disinfected before dispatch to a designated hatchery.

(12)

It is therefore appropriate that the competent authority of Italy may authorise the dispatch of consignments of day-old chicks and hatching eggs from the further restricted zones defined in this Decision according to the requirements laid down in Directive 2005/94/EC provided that Italy gives written notification in advance and the Member State or third country of destination confirms its prior agreement to receive these consignments.

(13)

In order to verify compliance with the provisions of this Decision, it is appropriate that the veterinary certificates provided for in Directive 2009/158/EC include a reference to that effect.

(14)

For the sake of clarity, Implementing Decision 2013/439/EU should be repealed.

(15)

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

(a)

the measures laid down in Article 30(c)(iii) second subparagraph and (iv) of Directive 2005/94/EC are applied;

(b)

the competent authority of the Member State or third country of destination is given written notification in advance and undertakes to receive the consignments of the day-old chicks and hatching eggs and notify their date of arrival at the holding of destination on its territory to the competent authority of Italy.

29.8.2013   

EN

Official Journal of the European Union

L 230/s3

29.8.2013   

EN

Official Journal of the European Union

L 230/s3