Commission Implementing Regulation (EU) No 359/2012
of 25 April 2012
approving the active substance metam, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Regulation (EC) No 33/2008.
The application was submitted to Belgium, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as those that were the subject of Decision 2009/562/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.
Belgium evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 31 August 2010.
The additional report by the rapporteur Member State and the new conclusions by the Authority concentrate on the concerns that led to the non-inclusion. Those concerns were in particular that it was not possible to demonstrate the acceptability of consumer exposure and lack of data with respect to the behaviour in the environment of the impurity N,N-dimethylthiourea (DMTU).
The new information submitted by the applicant shows that the exposure of consumers may be considered acceptable and the behaviour of DMTU in the environment will not result in unacceptable effects.
Consequently, the additional information provided by the applicant permits to eliminate the specific concerns that led to the non-inclusion.
It has appeared from the various examinations made that plant protection products containing metam may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular as regards the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve metam in accordance with Regulation (EC) No 1107/2009.
In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions.
Without prejudice to the conclusion that metam should be approved, it is, in particular, appropriate to require further confirmatory information.
A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.
Without prejudice to the obligations defined by Regulation (EC) No 1107/2009 as a consequence of the approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009 the following should, however, apply. Member States should be allowed a period after approval to review authorisations of plant protection products containing metam which have been maintained for certain uses in accordance with Article 3 of Decision 2009/562/EC. For the calculation of that period that provision is to be taken into account. Member States should, as appropriate, vary, replace or withdraw existing authorisations.
For plant protection products containing metam, where Member States grant any period of grace in accordance with Article 46 of Regulation (EC) No 1107/2009, Article 4 of Decision 2009/562/EC should be taken into account for the calculation of that period. Hence, such a period of grace should expire at the latest by 31 December 2014.
In the interest of clarity, Decision 2009/562/EC should be repealed.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
Article 1Approval of active substance
The active substance metam, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Article 2Re-evaluation of plant protection products
1.
Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing metam as an active substance by 31 December 2014.
By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in Part B of the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
2.
By way of derogation from paragraph 1, for each authorised plant protection product containing metam as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011, by 30 June 2012 Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account Part B of the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
Following that determination Member States shall:
(a)
in the case of a product containing metam as the only active substance, where necessary, amend or withdraw the authorisation by 30 June 2016;
(b)
in the case of a product containing metam as one of several active substances, where necessary, amend or withdraw the authorisation by 30 June 2016 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or substances, whichever is the latest.
Article 3Grace period
Where Member States withdraw or amend an existing authorisation in accordance with Article 2(1), any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 31 December 2014 at the latest.
Article 4Amendments to Implementing Regulation (EU) No 540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 5Repeal
Decision 2009/562/EC is repealed.
Article 6Entry into force and date of application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 July 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 April 2012.
For the Commission
The President
José Manuel Barroso
ANNEX I
Common Name, Identification Numbers | IUPAC Name | Purity10 | Date of approval | Expiration of approval | Specific provisions |
|---|---|---|---|---|---|
Metam CAS No 144-54-7 CIPAC No 20 | Methyldithiocarbamic acid | ≥ 965 g/kg Expressed as metam-sodium on a dry weight basis ≥ 990 g/kg Expressed as metam-potassium on a dry weight basis Relevant impurities:
| 1 July 2012 | 30 June 2022 | PART AOnly uses as nematicide, fungicide, herbicide and insecticide may be authorised for application as soil fumigant prior to planting, limited to one application every third year on the same field. The application may be authorised in open field by soil injection or drip irrigation, and in greenhouse by drip irrigation only. The use of gas-tight plastic film for drip irrigation shall be prescribed. The maximum application rate shall be 153 kg/ha (corresponding to 86,3 kg/ha of MITC) in case of open field applications. Authorisations shall be limited to professional users. PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012, shall be taken into account. In this overall assessment Member States:
The applicant shall submit confirmatory information on methyl isothiocyanate as regards:
The applicant shall submit to the Commission, the Member States and the Authority such information by 31 May 2014. |
ANNEX II
In Part B of the Annex to Implementing Regulation No (EU) 540/2011, the following entry is added:
No
Common Name, Identification Numbers
IUPAC Name
Purity11Date of approval
Expiration of approval
Specific provisions
‘22
Metam
CAS No 144-54-7
CIPAC No 20
Methyldithiocarbamic acid
≥ 965 g/kg
Expressed as metam-sodium on a dry weight basis
≥ 990 g/kg
Expressed as metam-potassium on a dry weight basis
Relevant impurities:
methylisothiocyanate (MITC)
max. 12 g/kg on dry weight basis (metam-sodium),
max. 0,42 g/kg on dry weight basis (metam-potassium).
N,N’-dimethylthiourea (DMTU)
max. 23 g/kg on a dry weight basis (metam-sodium),
max. 6 g/kg on a dry weight basis (metam-potassium).
1 July 2012
30 June 2022
PART A
Only uses as nematicide, fungicide, herbicide and insecticide may be authorised for application as soil fumigant prior to planting, limited to one application every third year on the same field.
The application may be authorised in open field by soil injection or drip irrigation, and in greenhouse by drip irrigation only. The use of gas-tight plastic film for drip irrigation shall be prescribed.
The maximum application rate shall be 153 kg/ha (corresponding to 86,3 kg/ha of MITC) in case of open field applications.
Authorisations shall be limited to professional users.
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012, shall be taken into account.
In this overall assessment Member States:
- (a)
shall pay particular attention to the protection of operators and shall ensure that the conditions of use include risk mitigation measures such as application of adequate personal protective equipment and a limitation in the daily work rate;
- (b)
shall pay particular attention to the protection of workers and shall ensure that the conditions of use include risk mitigation measures, such as use of adequate personal protective equipment, re-entry period and limitation in the daily work rate;
- (c)
shall pay particular attention to the protection of bystanders and residents and shall ensure that the conditions of use include risk mitigation measures, such as an appropriate buffer zone during and until 24 hours after the application from the perimeter of the application area to any occupied residences and areas used by the general public with obligation to use warning signs and ground markers;
- (d)
shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions and shall ensure that the conditions of use include risk mitigation measures, such as appropriate buffer zone;
- (e)
shall pay particular attention to the risk to non-target organisms and shall ensure that conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit confirmatory information on methyl isothiocyanate as regards:
- (1)
the assessment of the long-range atmospheric transport potential and related environmental risks;
- (2)
the potential groundwater contamination.
The applicant shall submit to the Commission, the Member States and the Authority such information by 31 May 2014.’