Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005

Abstract

According to Article 5(1) of Regulation (EC) No 396/2005, active substances of plant protection products evaluated under Directive 91/414/EEC for which no maximum residue levels (MRLs) are required shall be defined and listed in Annex IV to this Regulation. Among the active substances that need to be reviewed under Article 12 of Regulation (EC) No 396/2005, EFSA identified nine active substances that were already included in Annex IV of Regulation (EC) No 396/2005 by risk managers, without identifying any need for further assessment. EFSA prepared a statement explaining that for those nine active substances a review of MRLs is no longer necessary. The relevant question numbers are considered addressed by this statement.

Summary

Regulation (EC) No 396/2005 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. In accordance with Article 12(1) of that Regulation, the European Food Safety Authority (EFSA) shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing MRLs for that active substance. Article 12(2) of that Regulation stipulates that EFSA shall provide a reasoned opinion on the review of the existing MRLs for all active substances included in Annex I to Directive 91/414/EEC by 1 September 2009.

The general principles for the establishment and update of Annex IV are laid down in Article 5 of Regulation (EC) No 396/2005.

Among the active substances that need to be reviewed under Article 12 of Regulation (EC) No 396/2005, EFSA identified nine active substances that were already included in Annex IV of Regulation (EC) No 396/2005 by risk managers, without identifying any need for further assessment. EFSA therefore prepared a statement explaining that for these nine active substances a review of MRLs is no longer necessary. The corresponding question numbers (7) are also considered addressed by this statement.

The statement was circulated to Member States for consultation via a written procedure before finalisation.

1. Introduction

Regulation (EC) No 396/20051 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. In accordance with Article 12(1) of that Regulation, the European Food Safety Authority (EFSA) shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC2 a reasoned opinion on the review of the existing MRLs for that active substance. Article 12(2) of that Regulation stipulates that EFSA shall provide a reasoned opinion on the review of the existing MRLs for all active substances included in Annex I to Directive 91/414/EEC by 1 September 2009.

According to Article 5(1) of Regulation (EC) No 396/2005, active substances of plant protection products (PPPs) evaluated under Directive 91/414/EEC for which no MRLs are required shall be defined and listed in Annex IV to this Regulation, taking into account the uses of those active substances and the matters referred to in points (a), (c) and (d) of Article 14(2). The criteria for the inclusion of active substances into Annex IV of Regulation (EC) No 396/2005 are established in the European Commission guidance document (European Commission, 2015).

The Annex IV of the Regulation (EC) No 396/2005 was first established with Commission Regulation (EC) No 149/20083 to include substances for which it has been established in accordance with Article 5(1) of Regulation (EC) No 396/2005 that no MRLs were required. That Annex was further amended in accordance with the Commission Regulation (EU) 2015/16084 and Commission Regulation (EU) 2016/8055, to include additional substances.

The general principles for the establishment and update of Annex IV are laid down in Article 5 of Regulation (EC) No 396/2005, which requires that for an active substance which shall be included in Annex IV account should be taken of:

• the use of the active substance;

• the scientific and technical knowledge available;

• the result of an assessment of any potential risks to consumers with a high intake and high vulnerability and, where appropriate, to animals;

• the results of any evaluations and decisions to modify the use of plant protection products.

Among the active substances that need to be reviewed under Article 12 of Regulation (EC) No 396/2005, EFSA identified nine active substances that were already included in Annex IV of Regulation (EC) No 396/2005 by risk managers, without identifying any need for further assessment. EFSA therefore prepared a statement explaining that for these nine active substances a review of MRLs is no longer considered necessary. The corresponding question numbers (7) are also considered addressed by this statement.

EFSA has already published a statement explaining that for 39 substances a review of MRLs is no longer considered necessary (EFSA, 2016).

The draft statement was circulated to Member States for consultation via a written procedure. Comments received by 28 September 2017 were considered during the finalisation of this statement.

2. Assessment

2.1. Substances included in Annex IV following peer review by EFSA

Following the peer review by EFSA, the following substances are included in Annex IV without identifying any need for further assessment.

For Streptomyces K61 (formerly Streptomyces griseoviridis), EFSA could not conclude in its opinion (EFSA, 2013) 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 by the risk managers which concluded that the risk to humans through metabolites from this substance is negligible. In view of this, it was considered appropriate to include these substances in Annex IV to Regulation (EC) No 396/2005 via Commission Regulation (EU) 2016/805.

For urea, EFSA in its opinion (EFSA, 2012a) considered that a quantitative consumer dietary risk assessment was not necessary due to the specific methods of application of that substance. Urea (carbamide) is approved as a food additive in accordance with Regulation (EU) No 1129/2011 of the European Parliament and of the Council.6 In addition, the natural exposure to that substance is far higher than the one linked to the use of urea as a PPP. In view of this, it was considered appropriate to include this substance in Annex IV to Regulation (EC) No 396/2005 via Commission Regulation (EU) 2015/1608.

For paraffin oil (CAS 64742‐46‐7), paraffin oil (CAS 72623‐86‐0), paraffin oil (CAS 8042‐47‐5) and paraffin oil (CAS 97862‐82‐3), EFSA in its opinions (EFSA, 2009a,b) concluded that if it could be demonstrated that paraffin oils are of high purity, no toxicological concern would be raised and no acceptable daily intake (ADI), acceptable operator exposure level (AOEL) and acute reference dose (ARfD) would be required. Risk managers took note of an amended version of the review reports in which it is explained that the technical specifications comply with pharmaceutical grade (high purity). In view of this, it was considered appropriate to include these substances in Annex IV to Regulation (EC) No 396/2005 via Commission Regulation (EU) 2015/1608.

As regards Candida oleophila strain O, EFSA in its opinion (EFSA, 2012b) 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 by risk managers which concluded that the risk to humans through metabolites from this substance is negligible. In view of this, it was considered appropriate to include appropriate to include that substance in Annex IV to Regulation (EC) No 396/2005 via Commission Regulation (EU) 2016/805.

As regards FEN 560 (also called fenugreek or fenugreek seed powder), EFSA concluded (EFSA, 2010) that the inclusion of that substance in Annex IV to Regulation (EC) No 396/2005 is appropriate. In view of this, FEN 560 was included in Annex IV to Regulation (EC) No 396/2005 via Commission Regulation (EU) 2015/1608.

As regards terpenoid blend QRD 460, EFSA concluded (EFSA, 2014) that the inclusion of that substance in Annex IV to Regulation (EC) No 396/2005 is appropriate. In view of this, terpenoid blend QRD 460 was included in Annex IV to Regulation (EC) No 396/2005 via Commission Regulation (EU) 2015/1608.

Question number (MRL review)	Active substance	EMS	Status under Reg (EU) No 1107/2009	Peer Review by EFSA
EFSA‐Q‐2009‐00134	Streptomyces K 61 (formerly Streptomyces griseoviridis)	EE	Approved	EFSA (2013)
EFSA‐Q‐2009‐00195	Urea	EL	Approved	EFSA (2012a)
EFSA‐Q‐2010‐00195	Paraffin oil (CAS 8042‐47‐5)	EL	Approved	EFSA (2009a)
EFSA‐Q‐2010‐00196	Paraffin oil (CAS 64742‐46‐7), paraffin oil (CAS 72623‐86‐0) and paraffin oil (CAS 97862‐82‐3)	EL	Approved	EFSA (2009b)
EFSA‐Q‐2010‐01071	FEN 560 (also called fenugreek or fenugreek seed powder)	FR	Approved	EFSA (2010)
EFSA‐Q‐2013‐00350	Candida oleophila strain O	UK	Approved	EFSA (2012b)
EFSA‐Q‐2015‐00484	Terpenoid blend QRD 460	NL	Approved	EFSA (2014)

3. Conclusions

Among the active substances that need to be reviewed under Article 12 of Regulation (EC) No 396/2005, EFSA identified nine active substances that were already included in Annex IV of Regulation (EC) No 396/2005 by risk managers, without identifying any need for further assessment. EFSA therefore prepared a statement explaining that for these nine active substances a review of MRLs is no longer necessary. The corresponding question numbers (7) are considered addressed by this statement.

Other statements addressing additional active substances that do not require a review of MRLs may be issued by EFSA if needed.

Abbreviations

ADI

acceptable daily intake

AOEL

acceptable operator exposure level

ARfD

acute reference dose

CAS

Chemical Abstracts Service

MRL

maximum residue level

PPP

plant protection product

Suggested citation: EFSA (European Food Safety Authority) , 2017. Statement on pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(11):5046, 7 pp. 10.2903/j.efsa.2017.5046