# L_2016132EN.01009501.xml

| 21.5.2016 | EN | Official Journal of the European Union | L 132/95 |
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21.5.2016

EN

Official Journal of the European Union

L 132/95

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COMMISSION REGULATION (EU) 2016/805

of 20 May 2016

amending Annex IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards Streptomyces K61 (formerly S. griseoviridis), Candida oleophila strain O, FEN 560 (also called fenugreek or fenugreek seed powder), methyl decanoate (CAS 110-42-9), methyl octanoate (CAS 111-11-5) and terpenoid blend QRD 460

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 5(1) thereof,

Whereas:

| (1) | For Streptomyces K61 (formerly S. griseoviridis), Candida oleophila strain O, FEN 560 (also called fenugreek or fenugreek seed powder) and terpenoid blend QRD 460 no specific MRLs were set. As those substances were not included in Annex IV to Regulation (EC) No 396/2005, the default value of 0,01 mg/kg laid down in Article 18(1)(b) of that Regulation applies. Methyl decanoate (CAS 110-42-9) and methyl octanoate (CAS 111-11-5) belong to the group of fatty acids C7-C20 which is included in Annex IV to Regulation (EC) No 396/2005. |
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(1)

For Streptomyces K61 (formerly S. griseoviridis), Candida oleophila strain O, FEN 560 (also called fenugreek or fenugreek seed powder) and terpenoid blend QRD 460 no specific MRLs were set. As those substances were not included in Annex IV to Regulation (EC) No 396/2005, the default value of 0,01 mg/kg laid down in Article 18(1)(b) of that Regulation applies. Methyl decanoate (CAS 110-42-9) and methyl octanoate (CAS 111-11-5) belong to the group of fatty acids C7-C20 which is included in Annex IV to Regulation (EC) No 396/2005.

| (2) | As regards FEN 560 (also called fenugreek or fenugreek seed powder), the European Food Safety Authority (‘the Authority’) concluded (2) that the inclusion of that substance in Annex IV to Regulation (EC) No 396/2005 is appropriate. |
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(2)

As regards FEN 560 (also called fenugreek or fenugreek seed powder), the European Food Safety Authority (‘the Authority’) concluded (2) that the inclusion of that substance in Annex IV to Regulation (EC) No 396/2005 is appropriate.

| (3) | As regards terpenoid blend QRD 460, the Authority concluded (3) that the inclusion of that substance in Annex IV to Regulation (EC) No 396/2005 is appropriate. |
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(3)

As regards terpenoid blend QRD 460, the Authority concluded (3) that the inclusion of that substance in Annex IV to Regulation (EC) No 396/2005 is appropriate.

| (4) | As regards Streptomyces K61 (formerly S. griseoviridis) (4) the Authority could not conclude on the dietary risk assessment for consumers as some information was not available and further consideration by risk managers was necessary. Such further consideration was reflected in the review report (5) which concluded that the risk to humans through metabolites from this substance is negligible. It is therefore appropriate to include that substance in Annex IV to Regulation (EC) No 396/2005. |
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(4)

As regards Streptomyces K61 (formerly S. griseoviridis) (4) the Authority could not conclude on the dietary risk assessment for consumers as some information was not available and further consideration by risk managers was necessary. Such further consideration was reflected in the review report (5) which concluded that the risk to humans through metabolites from this substance is negligible. It is therefore appropriate to include that substance in Annex IV to Regulation (EC) No 396/2005.

| (5) | As regards Candida oleophila strain O (6) the Authority could not conclude on the dietary risk assessment for consumers as some information was not available and further consideration by risk managers was necessary. Such further consideration was reflected in the review report (7) which concluded that the risk to humans through metabolites from this substance is negligible. It is therefore appropriate to include that substance in Annex IV to Regulation (EC) No 396/2005. |
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(5)

As regards Candida oleophila strain O (6) the Authority could not conclude on the dietary risk assessment for consumers as some information was not available and further consideration by risk managers was necessary. Such further consideration was reflected in the review report (7) which concluded that the risk to humans through metabolites from this substance is negligible. It is therefore appropriate to include that substance in Annex IV to Regulation (EC) No 396/2005.

| (6) | Methyl decanoate (CAS 110-42-9) was included in Annex I to Council Directive 91/414/EEC (8) by Commission Directive 2008/127/EC (9) and is deemed to have been approved under Regulation (EC) No 1107/2009 of the European Parliament and of the Council (10). No relevant impurities were identified for that substance. In addition, natural exposure to methyl decanoate is far higher than the one linked to the use of that substance as a plant protection product. It is therefore appropriate to maintain that substance in Annex IV to Regulation (EC) No 396/2005 but separately from the group fatty acids C7-C20 to ensure transparency. |
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(6)

Methyl decanoate (CAS 110-42-9) was included in Annex I to Council Directive 91/414/EEC (8) by Commission Directive 2008/127/EC (9) and is deemed to have been approved under Regulation (EC) No 1107/2009 of the European Parliament and of the Council (10). No relevant impurities were identified for that substance. In addition, natural exposure to methyl decanoate is far higher than the one linked to the use of that substance as a plant protection product. It is therefore appropriate to maintain that substance in Annex IV to Regulation (EC) No 396/2005 but separately from the group fatty acids C7-C20 to ensure transparency.

| (7) | Methyl octanoate (CAS 111-11-5) was included in Annex I to Directive 91/414/EEC by Directive 2008/127/EC and is deemed to have been approved under Regulation (EC) No 1107/2009. No relevant impurities were identified for that substance. In addition, natural exposure to methyl octanoate is far higher than the one linked to the use of that substance as a plant protection product. It is therefore appropriate to maintain that substance in Annex IV to Regulation (EC) No 396/2005, but separately from the group fatty acids C7-C20 to ensure transparency. |
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(7)

Methyl octanoate (CAS 111-11-5) was included in Annex I to Directive 91/414/EEC by Directive 2008/127/EC and is deemed to have been approved under Regulation (EC) No 1107/2009. No relevant impurities were identified for that substance. In addition, natural exposure to methyl octanoate is far higher than the one linked to the use of that substance as a plant protection product. It is therefore appropriate to maintain that substance in Annex IV to Regulation (EC) No 396/2005, but separately from the group fatty acids C7-C20 to ensure transparency.

| (8) | Regulation (EC) No 396/2005 should therefore be amended accordingly. |
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(8)

Regulation (EC) No 396/2005 should therefore be amended accordingly.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(9)

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

HAS ADOPTED THIS REGULATION:

Article 1

In Annex IV to Regulation (EC) No 396/2005, the following entries are inserted in alphabetical order: ‘Streptomyces K61 (formerly S. griseoviridis)’, ‘Candida oleophila strain O’, ‘FEN 560 (also called fenugreek or fenugreek seed powder)’, ‘Methyl decanoate (CAS 110-42-9)’, ‘Methyl octanoate (CAS 111-11-5)’ and ‘Terpenoid blend QRD 460’.

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, 20 May 2016.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 70, 16.3.2005, p. 1.

1

(2)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance fenugreek seed powder (FEN 560). EFSA Journal 2010; 8(3):1448, 50 pp.

2

EFSA Journal

(3)  EFSA (European Food Safety Authority), 2014. Conclusion on the peer review of the pesticide risk assessment of the active substance terpenoid blend QRD-460. EFSA Journal 2014;12(10):3816, 41 pp.

3

EFSA Journal

(4)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance Streptomyces K61 (formerly Streptomyces griseoviridis). EFSA Journal 2013;11(1):3061, 40 pp.

4

Streptomyces

Streptomyces griseoviridis

EFSA Journal

(5)  Review report for the active substance Streptomyces K61 (formerly Streptomyces griseoviridis) finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 11 July 2008 in view of the inclusion of Streptomyces K61 (formerly Streptomyces griseoviridis) in Annex I of Directive 91/414/EEC. SANCO/1865/08 — rev. 5, 11 July 2014.

5

Streptomyces

Streptomyces griseoviridis

Streptomyces

Streptomyces griseoviridis

(6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance Candida oleophila strain O. EFSA Journal 2012;10(11):2944, 27 pp.

6

Candida oleophila

EFSA Journal

(7)  Review report for the active substance Candida oleophila strain O finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 15 March 2013 in view of the approval of Candida oleophila strain O as active substance in accordance with Regulation (EC) No 1107/2009. SANCO/10395/2013 rev 1, 15 March 2014.

7

Candida oleophila

Candida oleophila

(8)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

8

(9)  Commission Directive 2008/127/EC of 18 December 2008 amending Council Directive 91/414/EEC to include several active substances (OJ L 344, 20.12.2008, p. 89).

9

(10)  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

10

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