1.3.2007   

EN

Official Journal of the European Union

L 63/1

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the preparation set out in the Annex. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

(3)

The application concerns authorisation of the preparation of potassium diformate (Formi LHS) as a feed additive for piglets (weaned) and pigs for fattening, to be classified in the additive category ‘zootechnical additives’.

(4)

The method of analysis included in the application for authorisation in accordance with Article 7(3)(c) of Regulation (EC) No 1831/2003 concerns the determination of the active substance of the feed additive in feed. The method of analysis referred to in the Annex to this Regulation is therefore not to be understood as a Community method of analysis within the meaning of Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (2).

(5)

The European Food Safety Authority (the Authority) concludes in its opinion of 14 February 2006 (3) that the safety of this additive for the consumer, the user and the environment have already been established and will not be changed by the proposed use. It further concludes, that the use of the preparation does not have an adverse effect on this animal category and that the use of that preparation can improve the zootechnical parameters (average daily intake gain, feed to gain ratio) for piglets (weaned) and pigs for fattening. It considers that the post market monitoring plan provided by the applicant is appropriate. The opinion of the Authority recommends appropriate measures for user safety. This opinion also verifies the report on the method of analysis of the feed additive in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6)

The assessment of that preparation shows that the conditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation.

(7)

Article 1 of Commission Regulation (EC) No 1810/2005 of 4 November 2005 concerning a new authorisation for 10 years of an additive in feedingstuffs, the permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of new uses of certain additives already authorised in feedingstuffs (4) which had provided for an authorisation for that use under the transitional provisions of Regulation (EC) No 1831/2003 should therefore be deleted.

(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,

1.3.2007   

EN

Official Journal of the European Union

L 63/4

(1)

Regulation (EC) No 1774/2002 lays down health rules concerning animal by-products not intended for human consumption. In view of the strict nature of those rules, transitional measures have been granted.

(2)

Commission Regulation (EC) No 809/2003 of 12 May 2003 on transitional measures under Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the processing standards for category 3 material and manure used in composting plants (2) provides for certain transitional measures in order to give industry time to adjust and develop alternative processing standards for Category 3 material and manure used in composting plants until 31 December 2006.

(3)

Commission Regulation (EC) No 810/2003 of 12 May 2003 on transitional measures under Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards processing standards for category 3 material and manure used in biogas plants (3) provides for certain transitional measures in order to give industry time to adjust and develop alternative processing standards for Category 3 material and manure used in biogas plants until 31 December 2006.

(4)

On 7 September 2005, the European Food Safety Authority (EFSA) issued an opinion on the safety vis-à-vis biological risks of biogas and composting treatment standards of animal by-products.

(5)

On the basis of the abovementioned EFSA opinion, Commission Regulation (EC) No 208/2006 of 7 February 2006 amending Annexes VI and VIII to Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards processing standards for biogas and composting plants and requirements for manure (4) was adopted on 7 February 2006, laying down validation requirements for alternative processing standards.

(6)

The transitional measures laid down in Regulations (EC) No 809/2003 and (EC) No 810/2003 do not restrict the concerned operators in making use of the validation procedure introduced by Regulation (EC) No 208/2006.

(7)

Alternative processing standards may now be approved by the competent authority of Member States if the validation has been carried out successfully. However, the Member States need more time to complete validation procedures.

(8)

In addition, mesophilic fermentation processes are commonly used in certain regions of the EU. Such processes were not specifically addressed in the abovementioned EFSA opinion; however, they might not fulfil all requirements laid down for the validation of alternative processing standards. The Commission has therefore forwarded a question to EFSA seeking its advice on the safety of the mesophilic fermentation process. EFSA is currently evaluating the possible risks of this process.

(9)

While awaiting this advice from EFSA and in order to provide additional time to Member States for the validation of alternative processes, the transitional measures provided for in Regulations (EC) No 809/2003 and (EC) No 810/2003 should be extended for a further period of time to enable the Member States to authorise operators to continue to apply national rules for the processing standards for Category 3 materials and manure used in composting and biogas plants.

(10)

Regulations (EC) No 809/2003 and (EC) No 810/2003 should therefore be amended accordingly.

(11)

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

1.3.2007   

EN

Official Journal of the European Union

L 63/6

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the preparation set out in the Annex. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

(3)

The application concerns authorisation of a new use of the preparation Saccharomyces cerevisiae (NCYC Sc 47) (Biosaf SC 47) as a feed additive for horses to be classified in the additive category ‘zootechnical additives’.

(4)

The method of analysis included in the application for authorisation in accordance with Article 7(3)(c) of Regulation (EC) No 1831/2003 concerns the determination of the active substance of the feed additive in feed. The method of analysis referred to in the Annex to this Regulation is therefore not to be understood as a Community method of analysis within the meaning of Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (2).

(5)

The use of the preparation of Saccharomyces cerevisiae (NCYC Sc 47) was authorised for cattle for fattening by Commission Regulation (EC) No 316/2003 of 19 February 2003 concerning the permanent authorisation of an additive in feedingstuffs and the provisional authorisation of a new use of an additive already authorised in feedingstuffs (3) for piglets (weaned), by Commission Regulation (EC) No 2148/2004 of 16 December 2004 concerning the permanent and provisional authorisation of certain additives in feedingstuffs and the authorisation of a new use of an additive already authorised in feedingstuffs (4) for sows, by Commission Regulation (EC) No 1288/2004 concerning the permanent authorisation of certain additives and the provisional authorisation of a new use of an additive already authorised in feedingstuffs (5) for rabbits for fattening, by Commission Regulation (EC) No 600/2005 of 18 April 2005 concerning a new authorisation for 10 years of a coccidiostat as an additive in feedingstuffs, the provisional authorisation of an additive and the permanent authorisation of certain additives in feedingstuffs (6) for dairy cows, by Commission Regulation (EC) No 1811/2005 of 4 November 2005 (7) concerning the provisional and permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of a new use of an additive already authorised in feedingstuffs and for lambs for fattening by Commission Regulation No 1447/2006 of 29 September 2006 concerning the authorisation of a new use of Saccharomyces cerevisiae (Biosaf SC 47) as a feed additive (8).

(6)

New data were submitted in support of the application for authorisation for horses. The European Food Safety Authority (the Authority) concluded in its opinion of 12 September 2006 that the preparation of Saccharomyces cerevisiae (NCYC Sc 47) does not have an adverse effect on animal health, human health or the environment (9). It further concluded that the preparation of Saccharomyces cerevisiae (NCYC Sc 47) does not present any other risk for this additional animal category which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. According to that opinion, the use of that preparation is efficacious in improving fibre digestion in horses. The Authority does not consider that there is a need for specific requirements of post market monitoring. This opinion also verifies the report on the method of analysis of the feed additive in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003. The assessment of that preparation shows that the conditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation.

(7)

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

1.3.2007   

EN

Official Journal of the European Union

L 63/9

(1)

In the case of cereals and products of plant origin including fruit and vegetables, residue levels reflect the use of minimum quantities of pesticides necessary to achieve effective protection of plants, applied in such a manner that the amount of residue is as low as is practicable and toxicologically acceptable, having regard, in particular to the protection of the environment and the estimated dietary intake of consumers. In the case of foodstuffs of animal origin, residue levels reflect the consumption by animals of cereals and products of plant origin treated with pesticides and, where relevant, the direct consequences of the use of veterinary medicines. Community maximum residue levels (MRLs) represent the upper limit of the amount of such residues that might be expected to be found in commodities when good agricultural practices have been respected.

(2)

MRLs for pesticides are kept under review and changed to take account of new information and data. MRLs are fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residue in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported by the necessary data.

(3)

The Commission was informed that for phosphamidon and mevinphos current MRLs may need to be revised in the light of the availability of new information on the toxicology and consumer intake. The Commission asked the relevant rapporteur Member States to make proposals for the review of Community MRLs. Such proposals were submitted to the Commission.

(4)

The lifetime and short-term exposure of consumers to the pesticides referred to in this Directive via food products has been reassessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation (4). On that basis, it is appropriate to fix new MRLs, which will ensure that there is no unacceptable consumer exposure.

(5)

Where relevant, the acute exposure of consumers to those pesticides via each of the food products that may contain residues has been assessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation. It is concluded that the presence of pesticide residues at or below the new MRLs will not cause acute toxic effects.

(6)

Through the World Trade Organisation, the Community's trading partners have been consulted about the new MRLs and their comments on these levels have been taken into account.

(7)

The Annexes to Directives 76/895/EEC, 86/362/EEC and 90/642/EEC 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,

1.3.2007   

EN

Official Journal of the European Union

L 63/17

(1)

In the case of cereals and products of plant origin including fruit and vegetables, residue levels reflect the use of minimum quantities of pesticides necessary to achieve effective protection of plants, applied in such a manner that the amount of residue is as low as is practicable and toxicologically acceptable, having regard, in particular to the protection of the environment and the estimated dietary intake of consumers. Community maximum residue levels (MRLs) represent the upper limit of the amount of such residues that might be expected to be found in commodities when good agricultural practices have been respected.

(2)

MRLs for pesticides are kept under review and changed to take account of new information and data. MRLs are fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residue in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported by the necessary data.

(3)

A Member State informed the Commission of its desire to revise national MRLs in accordance with Article 8 of Directive 90/642/EEC in the light of concerns about consumer intake. Proposals for the review of Community MRLs were submitted to the Commission.

(4)

The lifetime and short-term exposure of consumers to the pesticides referred to in this Directive via food products has been reassessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation (2). On that basis, it is appropriate to fix new MRLs, which will ensure that there is no unacceptable consumer exposure.

(5)

Where relevant, the acute exposure of consumers to those pesticides via each of the food products that may contain residues has been assessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation. It is concluded that the presence of pesticide residues at or below the new MRLs will not cause acute toxic effects.

(6)

Through the World Trade Organisation, the Community's trading partners have been consulted about the new MRLs and their comments on these levels have been taken into account.

(7)

At the request of the Commission, EFSA (3) has given an opinion on the risk of the aldicarb MRLs in this Directive.

(8)

The Annexes to Directives 90/642/EEC should therefore be amended accordingly.

(9)

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

1.3.2007   

EN

Official Journal of the European Union

L 63/24

(1)

Directive 92/119/EEC lays down measures for the control of certain animal diseases. Specific provisions for swine vesicular disease are laid down in Annex II to that Directive.

(2)

Since Council Directives 72/461/EEC (3) and 80/215/EEC (4) have been repealed with effect from 1 January 2006, references to those Directives contained in Directive 92/119/EEC should be replaced by references to Annexes II and III to Directive 2002/99/EC.

(3)

It is appropriate to provide for a specific solution with respect to the marking of meat and its subsequent use, as well as the destination of the processed products, where the swine vesicular disease health situation so permits, provided that this is done in such a way that the degree of protection from swine vesicular by intra-Community trade or international trade is not impaired.

(4)

Certain Member States have informed the Commission that the identification mark provided for in Annex II to Directive 2002/99/EC is poorly accepted by operators and customers in the industry. Accordingly, it is appropriate to provide for an alternative identification mark that Member States may decide to apply. However, in the interests of controls, it is important that Member States inform the Commission beforehand, if they decide to apply the alternative identification mark in case of an outbreak of swine vesicular disease.

(5)

The alternative identification mark provided for in this Directive should be clearly distinguishable from other identification marks to be applied to pig meat in accordance with Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (5) or Commission Regulation (EC) No 2076/2005 of 5 December 2005 laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 (6).

(6)

Unlike the general provisions of Article 13 of Directive 92/119/EEC, the specific provisions for swine vesicular disease in Annex II to that Directive do not provide for an authorisation to remove the animals from a holding within the protection zone in case the removal prohibition is maintained beyond 30 days because of the occurrence of further cases of the disease. It is appropriate to provide for such derogation for holdings in which the keeping of animals for longer periods than 30 days would cause problems.

(7)

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)

Point 2 is amended as follows:

(b)

the following point (h) is added: ‘(h) (i) by way of derogation from point (g), for meat from the pigs referred to in point (f)(i) Member States may decide to use an other identification mark than the special identification mark set out in Annex II to Directive 2002/99/EC, provided that it is clearly distinguishable from other identification marks to be applied to pig meat in accordance with Regulation (EC) No 853/2004 of the European Parliament and of the Council (8) or Commission Regulation (EC) No 2076/2005 (9); Member States that decide to use the alternative identification mark shall inform the Commission thereof in the framework of the Standing Committee on the Food Chain and Animal Health. (ii) for the purpose of (i) the identification mark must be legible and indelible, the characters easily readable and clearly displayed. The identification mark must have following shape and contain following indications: XY means the relevant country code provided for in point 6 of Part B of Section I of Annex II to Regulation (EC) No 853/2004. 1234 means the approval number of the establishment referred to in point 7 of Part B of Section I of Annex II to Regulation (EC) No 853/2004.

(2)

the following point 5 is added:

1.3.2007   

EN

Official Journal of the European Union

L 63/26

(1)

The existing active substance tribenuron has been included in Annex I to Directive 91/414/EEC by Commission Directive 2005/54/EC (5).

(2)

The following new active substances have been included in Annex I to Directive 91/414/EEC: acetamiprid and thiacloprid by Commission Directive 2004/99/EC (6), imazosulfuron, methoxyfenozide, and S-metholachlor by Commission Directive 2005/3/EC (7), and milbemectin by Commission Directive 2005/58/EC (8).

(3)

The inclusion in Annex I to Directive 91/414/EEC of the active substances concerned was based on the assessment of the information submitted concerning the proposed use. Information relating to this use has been submitted by certain Member States in accordance with Article 4(1)(f) of that Directive. The information available has been reviewed and is sufficient to allow certain maximum residue levels (MRLs) to be fixed.

(4)

Where no Community MRL or provisional MRL exists, Member States are to establish a national provisional MRL in accordance with Article 4(1)(f) of Directive 91/414/EEC before plant protection products containing these active substances may be authorised.

(5)

The Commission review reports which were prepared for the inclusion in Annex I to Directive 91/414/EEC of the active substances concerned, fixed the Acceptable Daily Intake (ADI) and if necessary, the Acute Reference Dose (ARfD) for those substances. The exposure of consumers of food products treated with the active substance concerned has been assessed and evaluated in accordance with Community procedures. Account has also been taken of guidelines published by the World Health Organisation (9) and the opinion of the Scientific Committee for Plants (10) on the methodology employed. It has been concluded that the MRLs proposed will not lead to those ADIs or ARfD being exceeded.

(6)

In order to ensure that the consumer is adequately protected from exposure to residues resulting from unauthorised uses of plant protection products, provisional MRLs should be set for the relevant product/pesticide combinations at the lower limit of analytical determination.

(7)

The setting at Community level of such provisional MRLs does not prevent the Member States from establishing provisional MRLs for the substances concerned in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI to that Directive. It is considered that a period of four years is sufficient to permit the development of further uses of the active substance concerned. The provisional MRL should then become definitive.

(8)

It is therefore necessary to modify the MRLs set out in the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC, to allow for proper surveillance and control of the prohibition of their uses and to protect the consumer. Where MRLs have already been defined in the Annexes to those Directives, it is appropriate to amend them. Where MRLs have not already been defined, it is appropriate to set them for the first time.

(9)

Directives 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly.

(10)

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