legislation-profile

PPPR - Plant Protection Products Regulation

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

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 Community. 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). 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). Implementing Regulation (EU) No 540/2011 provides the list of approved active substances for PPPs. Annex III to Regulation (EC) 1107/2009 (as amended by Regulation (EU) 2021/383) provides the list of co-formulants that are not accepted for inclusion in a PPP.

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; list of co-formulants that are not accepted for inclusion in a PPP

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. Part B- Active substances approved under Regulation 1107/2009. This list’s dataset contains: Number; Common name, Identification numbers (CAS); IUPAC name; Purity; Date of approval; Expiration of approval; Specific provisions. Part C- Basic substances. Part D- Low-risk substances. Part E- Candidates for substitution approved under Regulation 1107/2009. (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 is 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) of Regulation 1107/2009. 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. (f) Regulation EU 284/2013 - setting data requirements for PPPs. This regulation gives 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, OJ L 026, 28.1.2012, p. 38 (540/2011) 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 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No 140/2014 of 13 February 2014 Corrigendum, OJ L 277, 22.10.2015, p. 60 (140/2014) 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 Implementing Regulation (EU) No 145/2014 of 14 February 2014 Commission Implementing Regulation (EU) No 149/2014 of 17 February 2014 Commission Implementing Regulation (EU) No 151/2014 of 18 February 2014 Commission Implementing Regulation (EU) No 154/2014 of 19 February 2014 Commission Implementing Regulation (EU) No 187/2014 of 26 February 2014 Commission Implementing Regulation (EU) No 192/2014 of 27 February 2014 Commission Implementing Regulation (EU) No 193/2014 of 27 February 2014 Commission Implementing Regulation (EU) No 462/2014 of 5 May 2014 Commission Implementing Regulation (EU) No 485/2014 of 12 May 2014 Commission Implementing Regulation (EU) No 486/2014 of 12 May 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Commission Implementing Regulation (EU) 2021/81 of 27 January 2021 Commission Implementing Regulation (EU) 2021/129 of 3 February 2021 Commission Implementing Regulation (EU) 2021/134 of 4 February 2021 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 Commission Implementing Regulation (EU) 2021/413 of 8 March 2021 Commission Implementing Regulation (EU) 2021/427 of 10 March 2021 Commission Implementing Regulation (EU) 2021/459 of 16 March 2021 Commission Implementing Regulation (EU) 2021/556 of 31 March 2021 Commission Implementing Regulation (EU) 2021/566 of 30 March 2021 Commission Implementing Regulation (EU) 2021/567 of 6 April 2021 Commission Implementing Regulation (EU) 2021/574 of 30 March 2021 Commission Implementing Regulation (EU) 2021/726 of 4 May 2021 Commission Implementing Regulation 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