Search Legislation

Commission Directive 2008/70/ECShow full title

Commission Directive 2008/70/EC of 11 July 2008 amending Council Directive 91/414/EEC to include tritosulfuron as an active substance (Text with EEA relevance)

 Help about what version

What Version

 Help about advanced features

Advanced Features

Close

This is a legislation item that originated from the EU

After exit day there will be three versions of this legislation to consult for different purposes. The legislation.gov.uk version is the version that applies in the UK. The EU Version currently on EUR-lex is the version that currently applies in the EU i.e you may need this if you operate a business in the EU.

The web archive version is the official version of this legislation item as it stood on exit day before being published to legislation.gov.uk and any subsequent UK changes and effects applied. The web archive also captured associated case law and other language formats from EUR-Lex.

Changes over time for: Commission Directive 2008/70/EC

 Help about opening options

Status:

EU Directives are being published on this site to aid cross referencing from UK legislation. After exit day no further amendments will be applied to this version.

U.K.

Commission Directive 2008/70/EC

of 11 July 2008

amending Council Directive 91/414/EEC to include tritosulfuron as an active substance

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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 Germany received on 8 June 2001 an application from BASF AG for the inclusion of the active substance tritosulfuron in Annex I to Directive 91/414/EEC. Commission Decision 2002/268/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 this 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 designated rapporteur Member State submitted a draft assessment report on 5 September 2002.

(3) For tritosulfuron the draft assessment reports were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 20 May 2008 in the format of the Commission review report for tritosulfuron.

(4) The documents and information on tritosulfuron were also submitted to the European Food Safety Authority (EFSA) for separate consultation. The EFSA was invited to prepare a scientific opinion on the toxicological relevance of the soil and groundwater metabolite TBSA of tritosulfuron in the context of the human risk assessment. The EFSA was asked whether, on the basis of the data available, the metabolite TBSA shows a genotoxic potential or an indication of impaired fertility and what are the implications for toxicological reference values for humans.

(5) In its opinion of 11 December 2007(3), the EFSA concluded that TBSA did not show any clastogenic or other genotoxic potential and has no direct effect on fertility and that therefore there is no requirement for any adjustment of the default safety factor for potential effect on fertility. That opinion was taken into account.

(6) It has appeared from the various examinations made that plant protection products containing the active substance concerned 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 tritosulfuron in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances may be granted in accordance with the provisions of that Directive.

(7) 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 six months after inclusion to review existing provisional authorisations of plant protection products containing tritosulfuron 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.

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

(9) 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 1U.K.

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

Article 2U.K.

1.Member States shall adopt and publish by 31 May 2009 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 June 2009.

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.

2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3U.K.

1.Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing tritosulfuron as active substance by 31 May 2009. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to tritosulfuron, 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 tritosulfuron 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 30 November 2008 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 tritosulfuron. 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 tritosulfuron as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2010 at the latest; or

(b)

in the case of a product containing tritosulfuron as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2010 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 4U.K.

This Directive shall enter into force on 1 December 2008.

Article 5U.K.

This Directive is addressed to the Member States.

Done at Brussels, 11 July 2008.

For the Commission

Androulla Vassiliou

Member of the Commission

ANNEXU.K.

In Annex I to Directive 91/414/EEC the following rows are added at the end of the table:

a

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

NoCommon name, identification numbersIUPAC namePurityaEntry into forceExpiration of inclusionSpecific provisions
‘192

Tritosulfuron

CAS No 142469-14-5

CIPAC No 735

1-(4-methoxy-6-trifluoromethyl-1,3,5-triazin-2-yl)-3-(2-trifluoromethyl-benzenesulfonyl)urea

≥ 960 g/kg

The following manufacturing impurity is of toxicological concern and must not exceed a certain amount in the technical material:

2-Amino-4-methoxy-6-(trifluormethyl)-1,3,5-triazine: <0,2 g/kg

1 December 200830 November 2018

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on tritosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

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

  • the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

  • the protection of aquatic organisms,

  • the protection of small mammals.

Conditions of use shall include risk mitigation measures, where appropriate.’

(1)

OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2008/45/EC (OJ L 94, 5.4.2008, p. 21).

(3)

Scientific Opinion of the Panel on Plant Protection Products and their Residues (PPR Panel) on a request from the European Commission on the toxicological relevance of the soil and groundwater metabolite TBSA of tritosulfuron in the context of the human risk assessment. The EFSA Journal (2007) 621, pp. 1-33.

Back to top

Options/Help

Print Options

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.

Close

See additional information alongside the content

Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.

Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the EU Official Journal
  • lists of changes made by and/or affecting this legislation item
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

Timeline of Changes

Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources