# L_2017319EN.01000601.xml

| 5.12.2017 | EN | Official Journal of the European Union | L 319/6 |
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5.12.2017

EN

Official Journal of the European Union

L 319/6

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COMMISSION REGULATION (EU) 2017/2229

of 4 December 2017

amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council as regards maximum levels for lead, mercury, melamine and decoquinate

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (1), and in particular Article 8(1) thereof,

Whereas:

| (1) | Directive 2002/32/EC provides that the use of products intended for animal feed which contain levels of undesirable substances exceeding the maximum levels laid down in Annex I to that Directive is prohibited. |
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(1)

Directive 2002/32/EC provides that the use of products intended for animal feed which contain levels of undesirable substances exceeding the maximum levels laid down in Annex I to that Directive is prohibited.

| (2) | The European Food Safety Authority (‘the Authority’) adopted a scientific opinion on the safety and efficacy of dicopper (l) oxide as feed additive for all species (2). In the opinion it is indicated that the levels of lead in dicopper (l) oxide exceed in certain cases the current Union maximum levels for lead but the levels found do not present a safety concern as the animal exposure to lead through the use of that additive would be lower than that resulting from the use of other copper compounds compliant with Union law. Based on the information provided, the maximum level for lead in feed additives belonging to the functional group of compounds of trace elements is not achievable on a consistent basis for dicopper (l) oxide by applying good manufacturing practices. It is appropriate to adapt the maximum level for lead in dicopper (l) oxide. |
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(2)

The European Food Safety Authority (‘the Authority’) adopted a scientific opinion on the safety and efficacy of dicopper (l) oxide as feed additive for all species (2). In the opinion it is indicated that the levels of lead in dicopper (l) oxide exceed in certain cases the current Union maximum levels for lead but the levels found do not present a safety concern as the animal exposure to lead through the use of that additive would be lower than that resulting from the use of other copper compounds compliant with Union law. Based on the information provided, the maximum level for lead in feed additives belonging to the functional group of compounds of trace elements is not achievable on a consistent basis for dicopper (l) oxide by applying good manufacturing practices. It is appropriate to adapt the maximum level for lead in dicopper (l) oxide.

| (3) | Many co-products and by-products of the food industry intended for pet food are mainly from tuna. The current maximum levels of mercury for those co-products and by-products are lower than the maximum level of mercury applicable to tuna for human consumption, which causes a shortage in the supply of such co-products and by-products compliant with the maximum level of mercury for use in pet food. Therefore it is appropriate to adapt the maximum level for mercury for fish, other aquatic animals and products derived intended for the production of compound feed for dogs, cats, ornamental fish and fur animals, whilst keeping a high level of animal health protection. |
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(3)

Many co-products and by-products of the food industry intended for pet food are mainly from tuna. The current maximum levels of mercury for those co-products and by-products are lower than the maximum level of mercury applicable to tuna for human consumption, which causes a shortage in the supply of such co-products and by-products compliant with the maximum level of mercury for use in pet food. Therefore it is appropriate to adapt the maximum level for mercury for fish, other aquatic animals and products derived intended for the production of compound feed for dogs, cats, ornamental fish and fur animals, whilst keeping a high level of animal health protection.

| (4) | The Authority adopted a scientific opinion on the safety and efficacy of guanidinoacetic acid (‘GAA’) for chickens for fattening, breeder hens and roosters, and pigs (3). The additive guanidinoacetic acid is specified to contain melamine as impurity up to 20 mg/kg. The Authority concluded that the contribution of GAA to melamine content in feed would be of no concern. Maximum level for melamine in feed has been established in Directive 2002/32/EC. No maximum level of melamine is yet established for GAA. Therefore it is appropriate to set a maximum level for melamine in GAA. |
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(4)

The Authority adopted a scientific opinion on the safety and efficacy of guanidinoacetic acid (‘GAA’) for chickens for fattening, breeder hens and roosters, and pigs (3). The additive guanidinoacetic acid is specified to contain melamine as impurity up to 20 mg/kg. The Authority concluded that the contribution of GAA to melamine content in feed would be of no concern. Maximum level for melamine in feed has been established in Directive 2002/32/EC. No maximum level of melamine is yet established for GAA. Therefore it is appropriate to set a maximum level for melamine in GAA.

| (5) | Commission Implementing Regulation (EU) No 291/2014 (4) reduced the withdrawal time for decoquinate from three days to zero days. Therefore the provision for the unavoidable carry-over of decoquinate in withdrawal feed for chickens for fattening should be deleted. |
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(5)

Commission Implementing Regulation (EU) No 291/2014 (4) reduced the withdrawal time for decoquinate from three days to zero days. Therefore the provision for the unavoidable carry-over of decoquinate in withdrawal feed for chickens for fattening should be deleted.

| (6) | Directive 2002/32/EC should therefore be amended accordingly. |
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(6)

Directive 2002/32/EC should therefore be amended accordingly.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of Standing Committee on Plants, Animals, Feed and Food, |
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(7)

The measures provided for in this Regulation are in accordance with the opinion of Standing Committee on Plants, Animals, Feed and Food,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Directive 2002/32/EC is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 4 December 2017.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 140, 30.5.2002, p. 10.

1

(2)  EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2016. Scientific opinion on the safety and efficacy of dicopper (l) oxide as feed additive for all animal species. EFSA Journal 2016;14(6):4509, 19 pp. doi:10.2903/j.efsa.2016.4509 http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2016.4509/epdf

2

(3)  EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2016. Scientific opinion on the safety and efficacy of guanidinoacetic acid for chickens for fattening, breeder hens and roosters, and pigs. EFSA Journal 2016;14(2):4394, 39 pp. doi:10.2903/j.efsa.2016.4394 http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2016.4394/epdf

3

(4)  Commission Implementing Regulation (EU) No 291/2014 of 21 March 2014 amending Regulation (EC) No 1289/2004 as regards the withdrawal time and maximum residues limits of the feed additive decoquinate (OJ L 87, 22.3.2014, p. 87).

4

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ANNEX

Annex I to Directive 2002/32/EC is amended as follows:

| (1) | Row 4 of Section I, Lead, is replaced by the following:







  Undesirable substance | Products intended for animal feed | Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 % |
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| ‘4. | Lead (12) |

(1)

Row 4 of Section I, Lead, is replaced by the following:

Undesirable substance

Products intended for animal feed

Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 %

‘4.

Lead (12)

Feed materials

with the exception of:

10

| — | forage (3); |
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—

forage (3);

30

| — | phosphates and calcareous marine algae; |
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—

phosphates and calcareous marine algae;

15

| — | calcium carbonate; calcium and magnesium carbonate (10); |
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—

calcium carbonate; calcium and magnesium carbonate (10);

20

| — | yeasts. |
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—

yeasts.

5

Feed additives belonging to the functional group of compounds of trace elements

with the exception of:

100

| — | zinc oxide; |
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—

zinc oxide;

400

| — | manganous oxide, ferrous carbonate, cupric carbonate, dicopper oxide. |
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—

manganous oxide, ferrous carbonate, cupric carbonate, dicopper oxide.

200

Feed additives belonging to the functional groups of binders and anti-caking agents

with the exception of:

30

| — | clinoptilolite of volcanic origin; natrolite-phonolite. |
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—

clinoptilolite of volcanic origin; natrolite-phonolite.

60

Premixtures (6)

200

Complementary feed

with the exception of:

10

| — | mineral feed; |
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—

mineral feed;

15

| — | long-term supply formulations of feed for particular nutritional purposes with a concentration of trace elements higher than 100 times the established maximum content in complete feed. |
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—

long-term supply formulations of feed for particular nutritional purposes with a concentration of trace elements higher than 100 times the established maximum content in complete feed.

60

Complete feed.

5’

| (2) | Row 5 of Section I, Mercury, is replaced by the following:







  Undesirable substance | Products intended for animal feed | Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 % |
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| ‘5. | Mercury (4) |

(2)

Row 5 of Section I, Mercury, is replaced by the following:

Undesirable substance

Products intended for animal feed

Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 %

‘5.

Mercury (4)

Feed materials

with the exception of:

0,1

| — | fish, other aquatic animals and products derived thereof intended for the production of compound feed for food producing animals; |
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—

fish, other aquatic animals and products derived thereof intended for the production of compound feed for food producing animals;

0,5

| — | tuna (Thunnus spp, Euthynnus spp. Katsuwonus pelamis) and products derived thereof intended for the production of compound feed for dogs, cats, ornamental fish and fur animals; |
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—

tuna (Thunnus spp, Euthynnus spp. Katsuwonus pelamis) and products derived thereof intended for the production of compound feed for dogs, cats, ornamental fish and fur animals;

1,0 (13)

| — | fish, other aquatic animals and products derived thereof, other than tuna and derived products thereof, intended for the production of compound feed for dogs, cats, ornamental fish and fur animals; |
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—

fish, other aquatic animals and products derived thereof, other than tuna and derived products thereof, intended for the production of compound feed for dogs, cats, ornamental fish and fur animals;

0,5 (13)

| — | calcium carbonate; calcium and magnesium carbonate (10). |
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—

calcium carbonate; calcium and magnesium carbonate (10).

0,3

Compound feed

with the exception of:

0,1

| — | mineral feed; |
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—

mineral feed;

0,2

| — | compound feed for fish; |
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—

compound feed for fish;

0,2

| — | compound feed for dogs, cats, ornamental fish and fur animals. |
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—

compound feed for dogs, cats, ornamental fish and fur animals.

0,3’

| (3) | Endnote 13 to section I: Inorganic contaminants and nitrogenous compounds, is replaced by the following:






  ‘(13) | The maximum level is applicable on wet weight basis’ |
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(3)

Endnote 13 to section I: Inorganic contaminants and nitrogenous compounds, is replaced by the following:

‘(13)

| (4) | Row 7 of Section I, Melamine, is replaced by the following:







  Undesirable substance | Products intended for animal feed | Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 % |
| --- | --- | --- | --- |
| ‘7. | Melamine (9) |

(4)

Row 7 of Section I, Melamine, is replaced by the following:

Undesirable substance

Products intended for animal feed

Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 %

‘7.

Melamine (9)

Feed

with the exception of:

2,5

| — | canned pet food |
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—

canned pet food

2,5 (11)

| — | the following feed additives: |
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—

the following feed additives:

| — | guanidino acetic acid (GAA); |
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—

guanidino acetic acid (GAA);

20

| — | urea; |
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—

urea;

—

| — | biuret. |
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—

biuret.

—’

| (5) | Row 1 of Section VII, Decoquinate is replaced by the following:







  Coccidiostat | Products intended for animal feed (1) | Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 % |
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| ‘1. | Decoquinate |

(5)

Row 1 of Section VII, Decoquinate is replaced by the following:

Coccidiostat

Products intended for animal feed (1)

Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 %

‘1.

Decoquinate

Feed materials

0,4

Compound feed for

| — | laying birds and chickens reared for laying (> 16 weeks); |
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—

laying birds and chickens reared for laying (> 16 weeks);

0,4

| — | other animal species |
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—

other animal species

1,2

Premixtures for use in feed in which the use of decoquinate is not authorised.

(2)’

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