Regulations on limits for coccidiostats or histomonostats in food resulting from the unavoidable cross-contamination with such substances in feed


Date FOR 2013-07-01-814


Ministry of Agriculture and Food, and Industry, Ministry of Fisheries, the Ministry of Health


Published in 2013 Booklet 10


Commencement 01.07.2013

Edited


Changes
FOR 2005-04-12-319

For
Norway

Legal

LOV-2003-12-19-124-§9, LAW-2003-12-19-124-§16 LOV-2003-12-19-124-§17, TO-2003-12-19- 1790, TO-2004-05-05-884

Promulgated
07.02.2013 kl. 14.50

Short Title
Regulation on limit values ​​for

Chapter Overview:

Main part
Ordinances

Adopted by the FSA 1 July 2013 pursuant to the Act of 19 December 2003 no. 124 relating to food production and food safety. (Food Act) § 9 first paragraph, § 16, second paragraph and § 17 subsection. Delegated Decision of 19 December 2003 no. 1790, delegating decision on 5 May 2004 no. 884.
EEA referrals EEA Agreement Annex I Sec. II. 1zzzzzb (Regulation (EC) no. 124/2009 as amended by Regulation (EC). 610/2012).

§ 1. Scope These regulations apply limits for coccidiostats or histomonostats in food resulting from the unavoidable cross-contamination with such substances in feed.
In case of conflict between the provisions of the Regulation and this determination, always goes provisions of the Regulation before.

§ 2. Regulation (EC) No. 124/2009 EEA Agreement Annex Chap. II (Regulation (EC) No. 124/2009 as amended by Regulation (EC). 610/2012) laying down limits for the presence of coccidiostats or histomonostats in food resulting from the unavoidable transfer of those substances to feed for non-target animals force of regulations, with the EEA adaptations given in Annex I, Chapter II, protocol 1 to the agreement and the EEA agreement in general.

§ 3. Inspection and decisions FSA supervises and may make the necessary decisions,. Food Act § 23, to achieve compliance with the provisions laid down in or pursuant to these regulations. The Authority can also issue individual decisions pursuant to the Food Act § 24 to § 26

§ 4. Penalties Violation of the provisions of these regulations or decisions made pursuant to these regulations is punishable under the Food Act § 28

§ 5. Exemption FSA may in special cases grant exemptions from the provisions of this regulation, provided that it does not conflict with Norway's international obligations, including the EEA agreement.

§ 6. Implementation These regulations come into force immediately.
Same time the following amendments to Regulation 12 April 2005 no. 319 on additives for use in animal nutrition: ---


Ordinances
To make it easy to find the wording of the regulations being implemented, renders we them in this section. The text below is for information only and is not part of the Regulations.

Consolidated Regulation (EC) No. 124/2009

Below we list the information Norwegian translation of Regulation (EC) No. 124/2009. This is because the act. Reason The act was amended by Regulation (EC). 610/2012. All amendments to the Act and the amendments and additions that follow from EEA adaptation of the basic act in accordance with Annex I is incorporated below.
► B Commission Regulation (EC) No. 124/2009
as amended by
► M1 Commission Regulation (EC). 610/2012 of 9 July 2012.

COMMISSION REGULATION (EC) No. 124/2009
of February 10, 2009
laying down limits for the presence of coccidiostats or histomonostats in food resulting from the unavoidable cross-contamination of feed off audience with these drugs

COMMISSION OF THE EUROPEAN COMMUNITIES -
regard to the Treaty establishing the European Community,
Having regard to Council Regulation (EEC) No. 315/93 of 8 February 1993 laying down Community procedures associated with contaminants in foodstuffs, 1 in particular Article 2 no. 3, and
Whereas:

1)
Coccidiostats and histomonostats are substances intended to kill or inhibit protozoa, which among other things can be approved for use as feed additives in accordance with Regulation (EC) No. 1831 / 2003 by 22 september 2003 on additives fôrvarer.2 in recognition of coccidiostats and histomonostats as feed additives set special conditions for use, such as the species of animals or animal groups additives are intended.

2)

Feed business operators may produce a variety of feed at the same plant, and different types of products may have produced consecutively on the same production line. It may happen that unavoidable traces of a product may remain in-line and end up in the beginning of production of a different feed. The transfer from one production lot to another is called "cross-contamination" and may occur for instance when coccidiostats or histomonostats are used as authorized feed additives. This can lead to contamination of feed produced subsequently by technically unavoidable traces of these substances end up in the "feed off the audience", ie in feed in which the use of coccidiostats or histomonostats are not authorized, such as feed that are intended for animals or - groups that are not covered by the authorization of the additive. This unavoidable cross-contamination may occur at all stages of production and processing of feed but also during storage and transport of feed.

3)
To prevent Member States to adopt national rules to prevent unavoidable cross-contamination of non-target Bailee with unapproved coccidiostats or histomonostats and the resulting incidence of these substances in derived feed, which would create obstacles to the internal market behavior, it is necessary to adopt harmonized community rules in this area.

4)
The inevitable cross-contamination of feed off audience with active substances contained in authorized coccidiostats and histomonostats are considered as undesirable substances in animal feed in accordance with Directive 2002/32 / EC 3 and the occurrence of these substances must not constitute a danger to animal or human health or the environment. Therefore limits for these substances in animal feed set out in Commission Directive 2009/8 / EF4 amending Annex I to Directive 2002/32 / EC.

5)
The occurrence of unavoidable cross-contamination of feed off audience with coccidiostats and histomonostats, even in concentrations below the limits laid down in Directive 2002/32 / EC may lead to the occurrence of residues of these substances in foodstuffs of animal origin. In order to protect animal and public health and since it is not yet set a maximum residue level (MRL) for the affected foodstuff within the scope of Council Regulation (EEC) No. 2377/90 of 26 June 1990 of a Community procedure for the determination of MRLs of veterinary medicinal products in foodstuffs of animal opprinnelse5 or within the scope of Regulation (EC) no. 1831/2003, should be established tolerances for the occurrence of active substances contained in coccidiostats and histomonostats in foodstuffs of animal origin originating from the feed in non-target, within the framework of Regulation (EEC) no. 315/93 laying down Community procedures relating to contaminants in foodstuffs.

6)
At the request of the Commission, the European Food Safety Authority (hereinafter referred to as 'the Authority') issued several uttalelser6 of the risks involved for animal and human health as a result of unavoidable cross-contamination of feed off audience with coccidiostats or histomonostats which is approved for use as feed additives. For each koksidiostatikum and histomonostatikum approved as an additive to animal feed, was authority's assessment based on a hypothetical cross contamination of 2%, 5% and 10% from feed produced with the highest permitted dose of koksidiostatikum or histomonostatikum, of feed outside the audience who then produced.

7)
Considering the conclusions of the various scientific opinions can be stated that the Authority generally found that the incidence of coccidiostats or histomonostats authorized for use as feed additives in feed non-target at concentrations typical of unavoidable cross-contamination, provided that all preventive measures are taken, hardly will have a negative impact on animal health, and that health hazards to consumers resulting from the ingestion of residues in foods derived from animals that have been exposed to cross-contaminate feed, is negligible.

8)

On the basis of the Authority's statements and the various methods currently used in Member States to prevent the unavoidable cross-contamination, the Ministry is proposing to set maximum levels for foodstuffs as laid down in the Annexes to this Regulation to ensure that the internal market works on a satisfactory manner and to protect human health. The provisions of the Annex should be reviewed by 1 July 2011 to take account of new scientific and technological knowledge.

9)
The limits set out in the Annex to this Regulation should be continuously adapted to changes in established MRLs in certain foodstuffs within the scope of Regulation (EEC) No. 2377/90 establishing a Community procedure for the setting of maximum residues of veterinary medicinal products in foodstuffs of animal origin within the scope of Regulation (EC) no. 1831/2003. Given that it can take time from these changes are adopted and the subsequent adaptation of the maximum levels established in Annex to this Regulation is implemented, should the latter not considered prejudicial MRLs of coccidiostats or histomonostats established in the framework of Regulation (EEC) No. 2377/90 or Regulation (EC) no. 1831/2003.

10)
As unavoidable cross-contamination of feed off audience with coccidiostats or histomonostats may mean that these substances occur as contaminants in derived food, should the problem be handled in a comprehensive and integrated approach by this Regulation is adopted and implemented simultaneously with Directive 2009/8 / EC laying down limits unavoidable cross-contamination of feed off audience with coccidiostats or histomonostats.

11)
The measures in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health -

ADOPTED THIS REGULATION:

Article 1

1. The foodstuffs indicated in the Annex to this Regulation shall not be marketed if they contain a contaminant listed in this Annex, in an amount that exceeds the limits specified in the Annex.
If the existence of a significant residual amount not to exceed the limits specified in the Annex, the competent authority should carry out investigations to confirm that the residue caused by unavoidable cross-contamination of feed and not illegal addition of coccidiostats or histomonostats.
Foodstuffs complying with the maximum specified in the Annex shall not be mixed with foodstuffs which exceed these limits.

2. When the limits specified in the Annex to this Regulation is used in animal feed which are dried, diluted, processed or composed of more than one ingredient, it must be considered that the concentration of the pollutant changed by drying, diluting or processing, as well as to the proportionate share of the ingredient in the product.

3. The limits set out in the Annex to this Regulation shall not affect the provisions and the MRLs established by Regulation (EEC) No. 2377/90 and the MRLs established by Regulation (EC) No. 1831/2003.

Article 2
This Regulation shall enter into force on the 20th day following its publication in the Official Journal.
It shall apply from 1 July 2009.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 February 2009.

For the Commission

Androulla VASSILIOU

Member of the Commission

ANNEX

Limits in foodstuffs


Substance Foodstuffs
Limiting mcg / kg wet weight

► M1
1. Lasalocid sodium
Food of animal origin from other animal species other than poultry:

- Milk,
1

- Live,

50
- Kidney,

20
- Other food.
5

► B
2. narasin
Food of animal origin from other animal species than chickens for fattening:

- Eggs,
2

- Milk,
1

- Live,

50
- Other food.
5

3. Salinomycin sodium
Food of animal origin from other animal species than chickens for fattening and oppfôringskaniner:

- Eggs,
3

- Live,
5

- Other food.
2

4. Monensin sodium
Food of animal origin from other animal species than chickens for fattening, turkeys and bovine (including dairy cattle):

- Live,
8

- Other food.
2

5. Semduramicin
Food of animal origin from other animal species than chickens for fattening.
2

► M1
6. Maduramicin
Food of animal origin from other animal species than chickens for fattening and turkey.

- Eggs,

12
- Other food.
2

► B

7. Robenidine
Food of animal origin from other animal species than chickens for fattening, turkeys and fattening and Breeding:

- Eggs,

25
- Liver, kidney, skin and fat,

50
- Other food.
5

8. Dekokinat
Food of animal origin from other animal species than chickens for fattening, cattle and sheep (except dairy animals)
20

9. Halofuginone
Food of animal origin from other animal species than chickens for fattening, turkeys and bovine except dairy animals:

- Eggs,
6

- Liver and kidney,

30
- Milk,
1

- Other food.
3

► M1
10. Nicarbazin
Food of animal origin from other animal species than chickens for fattening:

- Eggs,
300

- Milk,
5

- Live,
300

- Kidney,
100

- Other food.
50

11. Diclazuril
Food of animal origin from other animal species than chickens for fattening, turkeys for fattening, fattening and Breeding and swine:

- Eggs,
2

- Liver and kidney,

40
- Other food.
5