# L_2010154EN.01002101.xml

| 19.6.2010 | EN | Official Journal of the European Union | L 154/21 |
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19.6.2010

EN

Official Journal of the European Union

L 154/21

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COMMISSION DIRECTIVE 2010/38/EU

of 18 June 2010

amending Council Directive 91/414/EEC to include sulfuryl fluoride as active substance

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,

Whereas:

| (1) | In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 29 July 2002 an application from Dow AgroScience for the inclusion of the active substance sulfuryl fluoride in Annex I to Directive 91/414/EEC. Commission Decision 2004/131/EC (2) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. |
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(1)

In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 29 July 2002 an application from Dow AgroScience for the inclusion of the active substance sulfuryl fluoride in Annex I to Directive 91/414/EEC. Commission Decision 2004/131/EC (2) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

| (2) | For that active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The rapporteur Member State submitted a draft assessment report on 29 October 2004. |
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(2)

For that active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The rapporteur Member State submitted a draft assessment report on 29 October 2004.

| (3) | The assessment report was peer reviewed by the Member States and the European Food Safety Authority (EFSA) and presented to the Commission on 17 December 2009 (3). The draft review report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and was finalised on 12 March 2010 in the format of the Commission review report for sulfuryl fluoride. |
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(3)

The assessment report was peer reviewed by the Member States and the European Food Safety Authority (EFSA) and presented to the Commission on 17 December 2009 (3). The draft review report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and was finalised on 12 March 2010 in the format of the Commission review report for sulfuryl fluoride.

| (4) | It has appeared from the various examinations made that plant protection products containing sulfuryl fluoride may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include sulfuryl fluoride in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive. |
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(4)

It has appeared from the various examinations made that plant protection products containing sulfuryl fluoride may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include sulfuryl fluoride in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.

| (5) | Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that the inclusion of a substance in Annex I may be subject to conditions. It is appropriate, as regards sulfuryl fluoride, to require that the notifier submit further information on milling processing conditions necessary to ensure that residues of fluoride ion in cereals do not exceed the natural background levels, on tropospheric concentrations of sulfuryl fluoride and on estimates of sulfuryl fluoride atmospheric lifetime. |
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(5)

Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that the inclusion of a substance in Annex I may be subject to conditions. It is appropriate, as regards sulfuryl fluoride, to require that the notifier submit further information on milling processing conditions necessary to ensure that residues of fluoride ion in cereals do not exceed the natural background levels, on tropospheric concentrations of sulfuryl fluoride and on estimates of sulfuryl fluoride atmospheric lifetime.

| (6) | Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing provisional authorisations of plant protection products containing sulfuryl fluoride to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC. |
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(6)

Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing provisional authorisations of plant protection products containing sulfuryl fluoride to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

| (7) | It is therefore appropriate to amend Directive 91/414/EEC accordingly. |
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(7)

It is therefore appropriate to amend Directive 91/414/EEC accordingly.

| (8) | The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(8)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.

Article 2

Member States shall adopt and publish by 28 February 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from 1 March 2011.

When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

Article 3

1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing sulfuryl fluoride as active substance by 28 February 2011. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to sulfuryl fluoride are met, with the exception of those identified in part B of the entry concerning the active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13(2) of that Directive.

2.   By way of derogation from paragraph 1, for each authorised plant protection product containing sulfuryl fluoride as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 August 2010 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning sulfuryl fluoride. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.

Following that determination Member States shall:

| (a) | in the case of a product containing sulfuryl fluoride as the only active substance, where necessary, amend or withdraw the authorisation by 29 February 2012 at the latest; or |
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(a)

in the case of a product containing sulfuryl fluoride as the only active substance, where necessary, amend or withdraw the authorisation by 29 February 2012 at the latest; or

| (b) | in the case of a product containing sulfuryl fluoride as one of several active substances, where necessary, amend or withdraw the authorisation by 29 February 2012 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest. |
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(b)

in the case of a product containing sulfuryl fluoride as one of several active substances, where necessary, amend or withdraw the authorisation by 29 February 2012 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

Article 4

This Directive shall enter into force on 1 September 2010.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 18 June 2010.

For the Commission

The President

José Manuel BARROSO

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(1)  
  OJ L 230, 19.8.1991, p. 1.

1

(2)  
  OJ L 37, 10.2.2004, p. 34.

2

(3)  
  The EFSA Journal 2010; 8(1):1441. [66 pp.], Conclusion on the peer review of the pesticide risk assessment of the active substance sulfuryl fluoride (finalised: 17 December 2009).

3

The EFSA Journal

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ANNEX

In Annex I to Directive 91/414/EEC, the following entry is added at the end of the table:

| No | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Entry into force | Expiration of inclusion | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- |
| ‘311 | Sulfuryl fluoride
  CAS No 002699-79-8
  CIPAC No 757 | Sulfuryl fluoride | > 994 g/kg | 1 November 2010 | 31 October 2020 | PART A
  Only uses as insecticide/nematicide (fumigant) applied by professional users in sealable structures






  (a) | which are empty; or |

No

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

‘311

Sulfuryl fluoride

CAS No 002699-79-8

CIPAC No 757

Sulfuryl fluoride

> 994 g/kg

1 November 2010

31 October 2020

PART A

Only uses as insecticide/nematicide (fumigant) applied by professional users in sealable structures

(a)

which are empty; or

| (b) | where conditions of use ensure that consumer exposure is acceptable; |
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(b)

where conditions of use ensure that consumer exposure is acceptable;

may be authorised.

PART B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on sulfuryl fluoride, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In this overall assessment, Member States must pay particular attention to:

| — | the risk posed by inorganic fluoride through contaminated products, such as flour and bran that remained in the mill machinery during fumigation, or grain stored in silos in the mill. Measures are required to ensure that such products do not enter the food and feed chain, |
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—

the risk posed by inorganic fluoride through contaminated products, such as flour and bran that remained in the mill machinery during fumigation, or grain stored in silos in the mill. Measures are required to ensure that such products do not enter the food and feed chain,

| — | the risk to operators and the risk to workers, such as when re-entering a fumigated structure after aeration. Measures are required to ensure that they wear self containing breathing apparatus or other appropriate personal protective equipment, |
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—

the risk to operators and the risk to workers, such as when re-entering a fumigated structure after aeration. Measures are required to ensure that they wear self containing breathing apparatus or other appropriate personal protective equipment,

| — | the risk to bystanders by applying an appropriate exclusion zone around the fumigated structure. |
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—

the risk to bystanders by applying an appropriate exclusion zone around the fumigated structure.

Conditions of authorisation shall include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission further information and in particular, confirmatory data on:

| — | the mill processing conditions necessary to ensure that residues of fluoride ion in flour, bran and grain do not exceed the natural background levels, |
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—

the mill processing conditions necessary to ensure that residues of fluoride ion in flour, bran and grain do not exceed the natural background levels,

| — | tropospheric concentrations of sulfuryl fluoride. Measured concentrations should be updated regularly. The limit of detection for the analysis shall be at least 0,5 ppt (equivalent to 2,1 ng sulfuryl fluoride/m3 of tropospheric air), |
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—

tropospheric concentrations of sulfuryl fluoride. Measured concentrations should be updated regularly. The limit of detection for the analysis shall be at least 0,5 ppt (equivalent to 2,1 ng sulfuryl fluoride/m3 of tropospheric air),

| — | estimates of sulfuryl fluoride atmospheric lifetime based on worst case scenario, with respect to the global warming potential (GWP). |
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—

estimates of sulfuryl fluoride atmospheric lifetime based on worst case scenario, with respect to the global warming potential (GWP).

They shall ensure that the notifier provides such information to the Commission by 31 August 2012.’

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(1)  Further details on identity and specification of active substances are provided in the review report.

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