Address https://gelex.eu/eli/EU/regulation/2016/1313@2016-08-01/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2

THE EUROPEAN COMMISSION,

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

Having regard to 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, and in particular the first alternative of Article 21(3) thereof,

Whereas:

(1) The active substance was included in Annex I to Council Directive 91/414/EEC by Commission Directive 2001/99/EC.

(2) Active substances included in Annex I of Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011.

(3) The approval of the active substance glyphosate, as set out in the Annex to Implementing Regulation (EU) No 540/2011 expires 6 months from the date of receipt of the opinion of the Committee for Risk Assessment of the European Chemicals Agency by the Commission or 31 December 2017, whichever is the earlier.

(4) On 30 October 2015 the European Food Safety Authority (hereinafter the Authority) communicated to the Commission its statement on the toxicological assessment of POE-tallowamine (CAS No 61791-26-2), a substance frequently used as a co-formulant in plant protection products containing glyphosate. It concluded that compared to glyphosate, a significant toxicity of POE-tallowamine was observed on all endpoints investigated. Additional concerns were highlighted as regards the potential of POE-tallowamine to negatively affect human health when used in plant protection products containing glyphosate. The Authority also considered that a likely explanation for the medical data in humans for plant protection products containing glyphosate is that the toxicity is mostly driven by the POE-tallowamine component of the formulation.

(5) In accordance with Directive 2009/128/EC of the European Parliament and of the Council in conjunction with Article 55 of Regulation (EC) No 1107/2009, Member States should encourage the development and implementation of integrated pest management and of alternative approaches or techniques in order to reduce their dependency on the use of pesticides. As plant protection products containing glyphosate are widely used for non-agricultural applications, Member States should ensure that the use of plant protection products containing glyphosate is minimised or prohibited in areas such as public parks and gardens, sports and recreation grounds, school grounds and children's playgrounds and in the close vicinity of healthcare facilities.

(6) Plant protection products containing glyphosate are also used for pre-harvest applications. In certain situations pre-harvest uses to check or prevent undesired growth of weeds are in line with good agricultural practices. Nevertheless it appears that plant protection products containing glyphosate are also used with the intention to control the time point of harvest or to optimise the threshing, although these uses may not be considered within good agricultural practices. Such uses may therefore not be compliant with the provisions of Article 55 of Regulation (EC) No 1107/2009. Member States should therefore pay particular attention to compliance of pre-harvest uses with good agricultural practices when authorising plant protection products.

(7) The Commission invited the notifiers to submit their comments.

(8) In the light of current scientific and technical knowledge it is appropriate to amend the conditions of use of the active substance in particular by excluding the co-formulant POE-tallowamine (CAS No 61791-26-2) from the use in plant protection products containing glyphosate.

(9) Implementing Regulation (EU) No 540/2011 should be amended accordingly.

(10) In accordance with Article 27(2) of Regulation (EC) No 1107/2009, a list of co-formulants not accepted for inclusion in plant protection products shall be established. The Commission, the Authority and Member States have started work in view of establishing that list. In carrying out that work, the Commission will pay particular attention to potentially harmful co-formulants used in plant protection products containing glyphosate. The list of unacceptable co-formulants will be established in future in a separate act, in accordance with the procedural requirements set out in Article 27(2) of Regulation (EC) No 1107/2009.

(11) 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 the seventh column, specific provisions, of entry 25 on glyphosate in Part A of the Annex to Implementing Regulation (EU) No 540/2011, the text is replaced by the following: Only uses as herbicide may be authorised. 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 glyphosate, and in particular Appendices I and II thereof, as amended in the Standing Committee on Plants, Animals, Food and Feed on 27 June 2016 shall be taken into account. In this overall assessment Member States: Member States shall ensure that plant protection products containing glyphosate do not contain the co-formulant POE-tallowamine (CAS No 61791-26-2).

must pay particular attention to the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses,

must pay particular attention to risks from the use in specific areas referred to in Article 12(a) of Directive 2009/128/EC,

must pay particular attention to compliance of pre-harvest uses with good agricultural practices.

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, 1 August 2016. For the Commission The President Jean-Claude Juncker

Versions

1. 2016-08-01

Cited by

• Commission Regulation (EU) 2021/383 of 3 March 2021 amending Annex III to Regulation (EC) No 1107/2009 of the European Parliament and of the Council listing co-formulants which are not accepted for inclusion in plant protection products (Text with EEA relevance) Regulation · Grade B

  The use of polyethoxylated tallowamines (CAS No 61791-26-2) in plant protection products containing glyphosate was prohibited by Commission Implementing Regulation (EU) 2016/1313, as concerns were identified in relation to the toxicity of polyethoxylated tallowamines and their potential to negatively affect human health. Given that those concerns are due to the intrinsic properties of the substances concerned and are thus not limited to formulated products containing glyphosate but are equally valid for formulated products containing other active substances, polyethoxylated tallowamines should

• Commission Implementing Regulation (EU) 2017/2324 of 12 December 2017 renewing the approval of the active substance glyphosate 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) Regulation · Grade B

  As an opinion of the Committee for Risk Assessment of the Agency on the harmonised classification as regards carcinogenicity of glyphosate was deemed necessary, on 17 March 2016, the rapporteur Member State submitted a dossier in accordance with Article 37 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council, including for the hazard class on carcinogenicity. In view of the time required to assess such a dossier, the approval period of the active substance was extended until 6 months from the date of receipt of the opinion of the Committee for Risk Assessment of the Ag

• P8_TA(2018)0022 Setting up a special committee on the Union’s authorisation procedure for pesticides European Parliament decision of 6 February 2018 on setting up a special committee on the Union’s authorisation procedure for pesticides, its responsibilities, numerical strength and term of office (2018/2534(RSO)) 2018/C 463/16 Notice · Grade B

  having regard to Commission Implementing Regulation (EU) 2016/1056 of 29 June 2016 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval period of the active substance glyphosate and Commission Implementing Regulation (EU) 2016/1313 of 1 August 2016 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance glyphosate,

• P8_TA(2018)0022 Setting up a special committee on the Union’s authorisation procedure for pesticides European Parliament decision of 6 February 2018 on setting up a special committee on the Union’s authorisation procedure for pesticides, its responsibilities, numerical strength and term of office (2018/2534(RSO)) 2018/C 463/16 Notice · Grade B

  whereas concerns have been raised with regard to the application by the Commission of the approval criteria and precautionary principle laid down in Regulation (EC) No 1107/2009 when granting the technical extension of the approval of glyphosate in 2016, when adopting Implementing Regulation (EU) 2016/1313, and when adopting Implementing Regulation (EU) 2017/2324;

• P8_TA(2019)0023 Union's authorisation procedure for pesticides European Parliament resolution of 16 January 2019 on the Union’s authorisation procedure for pesticides (2018/2153(INI)) 2020/C 411/07 Notice · Grade B

  having regard to Commission Implementing Regulation (EU) 2016/1056 of 29 June 2016 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval period of the active substance glyphosate and Commission Implementing Regulation (EU) 2016/1313 of 1 August 2016 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance glyphosate,