legislation-profile

PPP - Plant Protection Products Regulation

Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances

Scope

This regulation lays down rules for the authorisation of plant protection products (PPP) in commercial form and for their placing on the market, use and control within the Communitsy. It lays down both rules for the approval of active substances, safeners and synergists, which PPP contain or consist of, and rules for adjuvants and co-formulants. This Regulation applies to products, in the form in which they are supplied to the user, consisting of or containing active substances, safeners or synergists, and intended for one of the uses as defined in the Article 2 (1).

Exemptions

No explicit exemptions from the regulation are defined. However, a set derogations from certain provisions is defined: Art. 4(7) derogations from the approval of an active substance in accordance to Annex II as per Art. 4(1), in case an active substance is necessary to control a serious danger to plant health which cannot be contained by other available means including non-chemical methods. However, this derogation shall not apply to active substances which are or have to be classified as carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A. Subsection 4- Derogations Art. 22 for low-risk active substances , which will be approved for a period not exceeding 15 years by way of derogation from Article 5 (first approval for period for 10 years). Art. 23 for basic substances, shall be approved for an unlimited period by derogation from Article 5. Art. 24 for candidates for substitution shall be approved for a period not exceeding 7 years by way of derogation from Art. 5. Subsection 5- Special cases This subsection defines authorisation procedures for special cases. Art. 47- placing on the market of low-risk plant protection products. Art. 48-placing on the market PPP containing a genetically modified organism. Art. 49- placing on the market of treated seeds.

Regulatory activities

Approval of active substances (Art. 4- Art. 22), safeners and synergists (Art. 25-26) and co-formulants (Art. 27) Authorisation of plant protection products (Section 1)

Relevant product types

Yes, list of PPP; pesticides categories

Reference documents

Art. 84 refers to the following Regulations: (a) Regulation EU 540/2011 - approved substances [Updated 03/09/2014] The regulation contains several lists: Part A- list of active substances deemed approved under Regulation 1107/2009. This list has 353 entries with the following dataset: Number; Common name, Identification numbers (CAS; CIPAC); IUPAC name; Purity; Date of approval; Expiration of approval; Specific provisions. Out of 353 entries, the number of individual and group entries is the following: -344 single substance entries with/without CAS number -4 'groups of substances' entries, out of which 2 are 'closed' and 2 are 'open groups' entries. Part B-Active substances approved under Regulation 1107/2009. This list has 88 entries and dataset includes: Number; Common name, Identification numbers (CAS); IUPAC name; Purity; Date of approval; Expiration of approval; Specific provisions. Out of 88 entries, 78 are individual substances and 10 are 'unclear' entries. Part C- Basic substances. This list has 8 entries and all 8 are individual substances. Part C- Basic substances. This list has 8 entries and all 8 are individual substances. (b) Regulation EU 546/2011 - uniform principles for evaluation and authorisation of PPPs. This regulation defines uniform principles for evaluation and authorisation of PPP as provided for in Article 29(6) of 1107/2009 Regulation. No list of substances in included in this regulation. (c) Regulation EU 547/2011 - labelling requirements for PPPs. (d) Regulation EU 283/2013 - setting data requirements for active substances. An application for approval of active substances shall be submitted by the producer of the active substance to a Member State (the rapporteur Member State) together with a summary and a complete dossier as provided for in Article 8(1) and (2). This regulation describes detailed table of content and structure of a dossier. (e) Communication - list of test methods and guidance documents. Includes test methods and specifications according to international organisations, e.g. EU, OECD, FAO, WHO, etc. (f) Regulation EU 284/2013 - setting data requirements for PPPs. This regulation gives a detailed data requirements for PPP provided for in Article 8 (1)(c ) of 1107/2009 Regulation.

Obligations based on CLP hazard class

Yes. Annex I- defines procedure and criteria for approval of active substances, safeners and synergists. Section 3.6.3.- 3.6.4 CLP specifies an active substance shall be approved if it is not or has not be classified in accordance to CLP regulation as carcinogen category 1A or 1B or toxic for reproduction category 1A or 1B. Section 3.6.5.- states that an active substances shall be approved if it is not considered to have endocrine disrupting properties.

Obligations based on properties of concerns

Yes. Section 3.7.1. - states that an active substance shall be approved where it is not considered to be a persistent organic pollutant (POP). Section 3.7.2. - states that an active substance shall be approved if it is not considered bot be PBT/vPvB.

EU-level occupational exposure limits

Not applicable

EU-level emission limit values

No provision

Substance-centric data source(s) at the EU level

EU Pesticides database: Database of active substances, safeners and synergists under 1107/2009 Regulation and their approval status. It also contains EU-Pesticides MRL levels for individual products to which the MRLs applies.

Industry submission system in place

Industry submits application for authorisation of PPP via Plant Protection Products Application Management System (PPPAMS) The system allows applicants to create and manage applications and submit these to Member States for evaluation.

Format for industry submission

Yes for submission of application for approval of active substance and for authorisation.

Owner

EFSA DG SANTE; DG ENV

Update process

The Commission shall maintain a list of approved active substances electronically available to the public. (Art. 13 (4)) Member States will maintain a list of minor uses for PPP already authorised in the MS for which is requested an extension of the authorisation. This list of minor uses will be readily accessible and updated at least once every 3 months. (Art. 57 (2))

Amendments

Corrigendum to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 as regards the list of approved active substances COMMISSION IMPLEMENTING REGULATION (EU) No 541/2011 of 1 June 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 542/2011 of 1 June 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 702/2011 of 20 July 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 703/2011 of 20 July 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 704/2011 of 20 July 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 705/2011 of 20 July 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 706/2011 of 20 July 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 736/2011 of 26 July 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 740/2011 of 27 July 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 786/2011 of 5 August 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 787/2011 of 5 August 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 788/2011 of 5 August 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 797/2011 of 9 August 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 798/2011 of 9 August 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 800/2011 of 9 August 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 806/2011 of 10 August 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 807/2011 of 10 August 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 810/2011 of 11 August 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 820/2011 of 16 August 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 974/2011 of 29 September 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 993/2011 of 6 October 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 1022/2011 of 14 October 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 1100/2011 of 31 October 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 1134/2011 of 9 November 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 1143/2011 of 10 November 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 1278/2011 of 8 December 2011 COMMISSION IMPLEMENTING REGULATION (EU) No 87/2012 of 1 February 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 127/2012 of 14 February 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 287/2012 of 30 March 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 359/2012 of 25 April 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 369/2012 of 27 April 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 571/2012 of 28 June 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 582/2012 of 2 July 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 589/2012 of 4 July 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 595/2012 of 5 July 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 597/2012 of 5 July 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 608/2012 of 6 July 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 637/2012 of 13 July 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 735/2012 of 14 August 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 746/2012 of 16 August 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 1037/2012 of 7 November 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 1043/2012 of 8 November 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 1197/2012 of 13 December 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 1237/2012 of 19 December 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 1238/2012 of 19 December 2012 COMMISSION IMPLEMENTING REGULATION (EU) No 17/2013 of 14 January 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 22/2013 of 15 January 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 175/2013 of 27 February 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 187/2013 of 5 March 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 188/2013 of 5 March 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 190/2013 of 5 March 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 200/2013 of 8 March 2013 Corrigendum to Commission Implementing Regulation (EU) No 200/2013 of 8 March 2013 approving the active substance ametoctradin, in accordance with Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 COMMISSION IMPLEMENTING REGULATION (EU) No 201/2013 of 8 March 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 350/2013 of 17 April 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 355/2013 of 18 April 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 356/2013 of 18 April 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 365/2013 of 22 April 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 366/2013 of 22 April 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 367/2013 of 22 April 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 368/2013 of 22 April 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 369/2013 of 22 April 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 373/2013 of 23 April 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 375/2013 of 23 April 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 378/2013 of 24 April 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 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November 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 1187/2013 of 21 November 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 1192/2013 of 22 November 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 1195/2013 of 22 November 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 1199/2013 of 25 November 2013 COMMISSION IMPLEMENTING REGULATION (EU) No 85/2014 of 30 January 2014 COMMISSION IMPLEMENTING REGULATION (EU) No 140/2014 of 13 February 2014 Corrigendum to Commission Implementing Regulation (EU) No 140/2014 of 13 February 2014 approving the active substance spinetoram, in accordance with Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 COMMISSION IMPLEMENTING REGULATION (EU) No 141/2014 of 13 February 2014 COMMISSION IMPLEMENTING REGULATION (EU) No 143/2014 of 14 February 2014 COMMISSION IMPLEMENTING REGULATION (EU) No 144/2014 of 14 February 2014 COMMISSION 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(EU) 2017/841 of 17 May 2017 COMMISSION IMPLEMENTING REGULATION (EU) 2017/842 of 17 May 2017 Corrigendum to Commission Implementing Regulation (EU) 2017/842 of 17 May 2017 renewing the approval of the low-risk active substance Coniothyrium minitans strain CON/M/91-08 in accordance with Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 COMMISSION IMPLEMENTING REGULATION (EU) 2017/843 of 17 May 2017 COMMISSION IMPLEMENTING REGULATION (EU) 2017/855 of 18 May 2017 COMMISSION IMPLEMENTING REGULATION (EU) 2017/856 of 18 May 2017 COMMISSION IMPLEMENTING REGULATION (EU) 2017/1113 of 22 June 2017 COMMISSION IMPLEMENTING REGULATION (EU) 2017/1114 of 22 June 2017 COMMISSION IMPLEMENTING REGULATION (EU) 2017/1115 of 22 June 2017 COMMISSION IMPLEMENTING REGULATION (EU) 2017/1125 of 22 June 2017 COMMISSION IMPLEMENTING REGULATION (EU) 2017/1186 of 3 July 2017 COMMISSION 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