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EUROPE: Update of the guidance document on the scope and borderline issues of Reg. (EC) No 1107/2009

In May 2021, the Commission published a revision of the working guidance document SANCO Doc 6621-99 initiated in 1994 and relating to the scope and limits of application of Regulation (EC) No 1107/2009. A table lists the various cases examined and the conclusions issued by the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF).

The guidance document also outlines the criteria to determine whether a product falls in the scope of the Regulation concerning plant protection products and the procedure to present a new request for interpretation for a case not listed in the table.

 

To download: 

SANCO Doc 6621-99 rev 62 – REGULATION (EC) No 1107/2009 – SCOPE AND BORDERLINE ISSUES – May 2021

 

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EUROPE: 27 March 2021, new rules for confidentiality claims for dossiers

The Transparency Regulation (EU) 2019/1381 entered into force on 27 March 2021.

From this date, new rules apply as regards the confidentiality of dossiers.

The applicants who want to request for certain information to be kept confidential pursuant to article 63 of Regulation (EC) 1107/2009 amended by Regulation (EU) 2019/1381 should submit with their applications the form « Request for certain information to be kept confidential » available in Annex 10 of the guidance document SANCO/13169/2010 Rev. 11 on zonal assessment, mutual recognition, withdrawal and amendment of authorisations.

By default, only the information regarding the identity of authors of vertebrate studies are considered as confidential. For all the other data for which confidentiality is claimed, the applicants must justify their request in the form. The applicants should demonstrate that the disclosure of such information potentially harms their interests to a significant degree.

See also our previous article:

EUROPE: Update of guidance document on zonal evaluation, mutual recognition, withdrawal and amendment of authorisations

 

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EUROPE – COM: Publication of the list of co-formulants banned in PPP

Following the public consultation of 16 January 2020 on the draft list of co-formulants banned in plant protection products and its revision in May 2020 (see our previous articles), the Commission published on 4 March 2021 on the Official Journal of the European Union the Regulation (EU) 2021/383 amending Annex III to Regulation (EC) No 1107/2009 listing co-formulants which are not accepted for inclusion in plant protection products.

The Regulation (EU) 2021/383 thus lists the co-formulants which are banned in the composition of plant protection products and adjuvants. Member states must then review the composition of the products currently authorised and withdraw or amend as soon as possible the authorisations of products containing these banned co-formulants, with a maximum deadline of 24 March 2023. Grace periods are set at a maximum of 3 months for sale and distribution and 9 additional months for the disposal, storage and use from the date of amendment or withdrawal of the authorisation.

However, the co-formulants listed in the annex may be present as unintentional impurities in other authorised co-formulants at a concentration not exceeding 0.1 % w/w in the finished plant protection product or adjuvant. For one co-formulant (Benzo[def]chrysene, CAS number 50-32-8, EC number 200-028-5), this limit is lowered to 0.01 % w/w in the finished product (specific concentration limit related to CMR properties).

 

To download: 

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

 

See also our previous articles: 

EUROPE – COM: Update of the draft list of co-formulants banned in PPP

EUROPE – COM / Public Consultation: Draft List of Co-formulants Banned in PPP

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

 

EUROPE: Update of guidance document on zonal evaluation, mutual recognition, withdrawal and amendment of authorisations

The European Commission has published an update of the guidance document SANCO/13169/2010 Rev. 11 on zonal evaluation and mutual recognition, withdrawal and amendment of authorisations under Regulation (EC) No 1107/2009. This version updates the revision of July 2014. It has been finalised in the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) on 25 January 2021 and applies to all applications submitted from 01 March 2021.

This new revision now includes the procedures to be followed for applications of plant protection products authorisation according to Article 34 of Regulation (EC) No 1107/2009 (exemption from the submission of studies), withdrawals or amendments of an authorisation (Articles 44 and 45) and grace periods under Article 46. The procedures for placing on the market of low-risk plant protection products according to Article 47 are also described and appendices have been added.

The guidance document also highlights the importance of the zonal evaluation procedure for any application for new authorisations, which will then be subject to commenting from other Member States in the zone. Appendix 1 on the commenting requirements for each type of application has thus been updated.

Also note the ongoing implementation of the Plant Protection Products Application Management System (PPPAMS) on which the applicants are encouraged to use to submit their application (already suitable for Art. 33, Art. 40-42 and Art. 53).

 

To download: 

SANCO/13169/2010 Rev. 11 – Guidance document on zonal evaluation and mutual recognition, withdrawal and amendment of authorisations under Regulation (EC) No 1107/2009

 

Lynxee consulting’s team is at your disposal to answer your questions.

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EUROPE – COM: Update of the draft list of co-formulants banned in PPP

Following the public consultation of 16 January 2020 on the draft Regulation implementing the list of co-formulants that shall not be used in plant protection products or adjuvants (Annex III of Regulation (EC) No. 1107/2009), new versions of the draft Regulation and its Annex have been released for the SCoPAFF (Standing Committee on Plants, Animals, Food and Feed) of 18 and 19 May 2020.

The only major change in the draft Regulation concerns item (14) in which the acceptable limit of unauthorised co-formulants in PPPs and adjuvants has been increased from 0.01 % to 0.1 % (w/w).

In the updated version of the Annex, major changes are:

  • Grouping of nonylphenols and addition of isononylphenol (CAS No. 11066-49-2);
  • Grouping of nonylphenols, ethoxylated and adjustments of CAS and EC numbers;
  • Addition of the octylphenol group including 34 compounds;
  • Grouping of octylphenols, ethoxylated;
  • Removal of several mineral compounds: kaolin (aluminium silicate), quartz sand, kieselguhr (silicium dioxide), cristobalite (SiO2), trydimite (SiO2) and attapulgite (palaygorskite).

The table below details the changes that have been noted in comparison to the January 2020 version:

Previous version of Draft Annex (January 2020) New version of Draft Annex (May 2020)
Footnote 1 : 0.01 % (w/w) Replaced by 0.1 % (w/w)
Line 4. : EC No. 203-458-1 [2-ethoxyethanol] Replaced by EC No. 203-804-1 (Line 3.)
Line 24. : Aluminium silicate (Kaolin) Removal of co-formulant
Line 25. : EC No. 500-153-8 [POE-tallowamine] EC No. deleted (Line 11.)
Line 26. : EC No. 614-378-5 [POEP-tallowamine] EC No. deleted (Line 12.)
Lines 27 to 32 : Column 2 “Name” Fusion of 6 lines in “Asbestos fibres” (Lines 13 to 18)
Line 27. : EC No. 616-471-6 [Actinolite asbestos] EC No. deleted (Line 13.)
Line 28. : EC No. 601-801-3 [Amiosite asbestos] EC No. deleted (Line 14.)
Line 30. : CAS No. 132207-32-0- [Chrysotile asbestos] CAS No. deleted (Line 16.)
Line 33. : Attapulgite (Palaygorskite) Removal of co-formulant
Line 35. : Carcinogenic cat.1B [benzo[def]chrysene] Replaced by Carcinogenic cat.1B / Mutagenic cat.1B / Toxic to reproduction cat.1B (Line 20.)
Line 36. : CAS No. 10043-35-3 and EC No. 233-139-2 [Boric acid] Replaced by CAS No. 10043-35-3; 11113-50-1 and EC No. 233-139-2; 234-343-4 (Line 22.)
Line 39. : Cristobalite (SiO₂) Removal of co-formulant
Line 54. : Carcinogenic cat.1B [Ethylene oxide] Replaced by Carcinogenic cat.1B / Mutagenic cat.1B (Line 41.)
Line 68. : Reproductive toxicity cat.1B / Carcinogenic cat.2 [Nitrobenzene] Replaced by Toxic to reproduction cat.1B (Line 54.)
Line 82. : CAS No. 7311-27-5 [Orthoboric acid, sodium salt] Replaced by CAS No. 13840-56-7 (Line 28.)
Line 86. : Quartz sand Removal of co-formulant
Line 87. : Silicium dioxide (Kieselguhr) Removal of co-formulant
Line 90. : Trydimite (SiO₂) Removal of co-formulant
Lines 71 to 80 : Column 2 “Name”

Fusion of 10 lines in “Nonyl-phenols: Substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in any position to phenol, covering also substances, which include any of the individual isomers or a combination thereof.” (Lines 56 to 60 and 62 to 66) + addition of Line 61. : Isononylphenol

Lines 11 to 20, Line 23, Line 70 : Column 2 “Name”

Fusion of 12 lines in “Nonyl-phenols, ethoxylated: Substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in any position to phenol, ethoxylated, covering also substances, which include any of the individual isomers or a combination thereof.” (Lines 67, 70 to 72 and 74 to 81) + addition of Line 68. : 4-Nonylphenol, branched, 1-2.5 moles ethoxylated, Line 69. : 4-Nonylphenol, 1 – 2.5 moles ethoxylated and Line 73. : Ethanol,2-[2-[2-[2-(4-Nonylphenoxy) ethoxy] ethoxy] ethoxy]

Lines 21 and 81 : Column 2 “Name”

Fusion of 2 lines in “Octyl-phenols, ethoxylated: Substances with a linear and/or branched alkyl chain with a carbon number of 8 covalently bound in any position to phenol, ethoxylated, covering also substances, which include any of the individual isomers or a combination thereof.” (Lines 116 and 117)

/

Addition of 34 lines in familly “Octyl-phenols: Substances with a linear and/or branched alkyl chain with a carbon number of 8 covalently bound in any position to phenol, covering also substances, which include any of the individual isomers or a combination thereof.” (Lines 82 to 115)

To download: 

New Draft Commission Regulation amending Annex III of Regulation (EC) 1107/2009 and its Annex

 

See also our previous articles: 

EUROPE – COM / Public Consultation: Draft List of Co-formulants Banned in PPP

EUROPE-COM : draft list of co-formulants banned in PPP

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

 

EUROPE – COM / Public Consultation: Draft List of Co-formulants Banned in PPP

European Commission started on 16 January 2020 a public consultation on the draft regulation implementing the list of co-formulants that shall not be used in plant protection products or adjuvants (Annex III of Regulation (EC) No. 1107/2009). The consultation will end on 13 February 2020.

Updated versions of the draft regulation and its annex (including the list of banned co-formulants) can be downloaded via the public consultation website or via the download links below.

The new version of the regulation now specify that the grace period that can be granted by Member States for PPP or adjuvants containing a co-formulant listed in Annex III to Regulation (EC) No 1107/2009 shall expire for the sale and distribution at the latest 3 months and for the disposal, storage and use additional 9 months after the amendment or withdrawal of the authorisations.

In the new version of the annex, the following modifications are found for the entries Aluminium silicate (kaolin), Quartz sand and Silicium dioxide (in yellow) in comparison to the version of July 2019:

To download: 

New Draft Commission Regulation modifying Annex III of Regulation (EC) 1107/2009 and its Annex

 

See also our previous articles: 

EUROPE-COM : draft list of co-formulants banned in PPP

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

 

EUROPE-COM : draft list of co-formulants banned in PPP

The EU draft regulation implementing the list of co-formulants that shall not be used in plant protection products or adjuvants (Annex III of Regulation (EC) No. 1107/2009) was discussed in the SCoPAFF meeting of 16 and 17 July 2019.

Co-formulants are unacceptable in plant protection products if it is established that their use or their residues have a harmful effect on human or animal health or have an unacceptable effect on plants or on the environment.

According to the draft list, the following co-formulants are considered as unacceptable:

– substances with a harmonized classification as carcinogens, category 1A or 1B, or as cell mutagens, category 1A or 1B, or as toxic to reproduction, category 1A or 1B,

– substances identified as persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB),

– substances identified as substances of very high concern due to endocrine disrupting properties,

– substances identified as Persistent Organic Pollutants (POP),

– substances restricted under REACH where their use as a co-formulant in plant protection products is covered by the restriction,

– substances already identified as unacceptable co-formulants for plant protection products by Member States (Austria, Belgium, France, Germany, Italy, Lithuania, Spain and Norway) or during the renewal of approval process of active substance (i.e. POE-tallowamines),

– in-can preservatives that were not approved under the Biocide Regulation (EU) No 528/2012 due to unacceptable risks for human health and the environment (i.e. PHMB),

 

The draft regulation sets that unacceptable co-formulants may be present as unintentional impurities in other co-formulants provided their individual concentration in the finished plant protection product or adjuvant is less than 0.01 % (w/w) unless a different LoQ (Limit of Quantification) is provided.

At last, the draft Regulation sets that Member States must withdraw authorisations of products containing any of the listed unacceptable co-formulants at the latest by 2 years after entry into force of the list. A grace period of 12 months may be granted.

To download:

Draft Commission Regulation modifying Annex III of Regulation (EC) 1107/2009 and its Annex

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

EUROPE: Adoption of Timelines for Additional Data on ED for AIR III Active Substances

As adopted by the Commission, the new scientific criteria to identify endocrine disruptors (ED) (Reg. (EU) 2018/605) and the associated EFSA/ECHA guidance (EFSA Journal 2018;16(6):5311) are applicable for the assessment of all active substances (AS) since 10 November 2018, including the AS being under renewal (AIR III renewal programm) for which no draft regulation has been voted by the Committee.

For those AS still being under renewal by 10 November 2018, the Reg. (EU) No 2018/1659, recently adopted, amends Reg. (EU) No 844/2012 to define new timelines specifically dedicated to the submission and assessment of complementary data as regards endocrine disruption. A summary of the new timelines is presented below.

AS for which the new EFSA conclusion is not adopted by 10 November 2018:

  • If additional data are deemed necessary by Member States (MS) and EFSA to assess if the ED criteria are met: data expected are detailed and justified, and a period between 3 and 30 months is set for the submission by the applicant (depending on the type of data required).
  • If no additional data are deemed necessary by MS and EFSA to assess if the ED criteria are met: after having been informed, the applicant may submit additional data as regards ED properties of the AS within 3 months.
  • For both situations described above, the applicant may also provide supporting information as regards the potential derogation for ED active substances according to Article 4(7) of Reg. (EC) No 1107/2009 within the respective period set.
  • After the submission of data by the applicant, the RMS shall produce a revised renewal assessment report (RAR) within 90 days. Then, after the submission of the revised RAR, a conclusion on the AS shall be adopted by EFSA within 120 days. This period includes a consultation of MS and of the applicant on the revised RAR.
  • Non-requested data or data submitted by the applicant after the expiry of the period set for its submission will not be considered.

AS for which the new EFSA conclusion is adopted by 10 November 2018 (but no draft Regulation has been voted by the Committee):

  • The Commission may consider that additional information as regards endocrine disruption are needed to apply the adopted criteria and hence request a revision of the assessment by EFSA within a reasonable time period.
  • In the case of a revision request, same conditions and timelines as presented above (AS for which the new EFSA conclusion is not adopted by 10 November 2018) apply.
  • If no data are submitted by the applicant, EFSA shall conclude the assessment within 30 days.

 

To download:

Regulation (EU) No 2018/1659 of 7 November 2018 amending Reg. (EU) No 844/2012 in view of the scientific criteria for the determination of endocrine disrupting properties introduced by Reg. (EU) No 2018/605.

 

See also our previous articles:

EUROPE – COM: Availability and applicability of the EFSA/ECHA guidance on identifying endocrine disruptors

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

 

EUROPE: Publication of the supporting study for the ‘REFIT’ of Reg. (EC) No. 1107/2009 and No. 396/2005

The European Commission started in 2016 the application of the Regulatory Fitness and Performance programme (REFIT) to the European Regulation on pesticides (Regulation (EC) No. 1107/2009) and their residues (Regulation (EC) No. 396/2005). The aim of applying the REFIT programme is to assess if the current Regulations are ‘fit for purpose’ and meet the needs of citizens, businesses and public institutions in an efficient manner. In particular, the evaluation addresses synergies, gaps, inefficiencies and administrative burdens.

The main evaluation criteria set out to be addressed in relation to this REFIT Evaluation are:

  • Effectiveness of the intervention
  • Efficiency in relation to resources used
  • Relevance in relation to identified needs and problems
  • Coherence with other interventions with common objective
  • EU added value compared to what could have been achieved by EU country or international action.

The evaluation study, based on those criteria, which will support the REFIT evaluation was conducted between 2017 and 2018 by external contractors. The final report of the study was recently published (18 October 2018) and can be downloaded from the links below.

The analysis is based on data collected via case studies and consultation of stakeholders (EFSA, European Commission, Member State competent authorities, SME panel, etc.) and via an open public consultation which involved almost 10,000 citizens. The data analysis notably included timeline tracking and an analysis of the costs and benefits of the Regulations.

The main conclusions of the external evaluation study are:

  • The pesticide Regulation (EC) No. 1107/2009 led to an improved harmonisation of active substance and plant protection product (PPP) registration procedures in the EU, and it contributes to the protection of both human health and the environment. Nevertheless, important issues affecting the regulatory processes were identified. The lack of capacity and resources in MSs and at EFSA and the zonal system (in particular mutual recognition) not delivering as expected are among the key issues identified.
  • The MRL Regulation (EC) No. 396/2005 is generally effective in achieving its objectives. It ensures a high level of consumer protection and facilitates the functioning of the internal EU market. The main difficulties identified are related to the MRL revision procedure according to Art. 12, which is considered not ‘fit for purpose’. Besides, the current provisions for setting MRLs for non-chemical active substances are deemed inadequate.

The following issues were also underlined for both Regulations:

  • The delay for implementing and applying several provisions (e.g. assessment of the cumulative risk for consumers) creates obstacles to ensuring a high level of protection for both human health and the environment.
  • Active substances and PPPs not assessed in a timely manner often lead to unsatisfactory evaluations in light of the latest scientific and technical knowledge. The delays also lead to uncertainty and unpredictability which affect companies, particularly SMEs, in their capacity to innovate and to propose alternative solutions to replace hazardous substances.

The Commission REFIT evaluation, based on the results of this external evaluation study, is foreseen to be finalised in the first half of 2019.

 

To download:

Study supporting the REFIT Evaluation of the EU legislation on plant protection products and pesticides residues (Regulation (EC) No 1107/2009 and Regulation (EC) No 396/2005)

Executive summary

Final report

Annexe I : Synopsis report

Annexe II : Methodology and cost calculations

Annexe III : Consultation activities – surveys and interviews

 

Lynxee consulting’s team is at your disposal to answer your questions.

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EUROPE: Draft report of the PEST Committee on the Union’s authorisation procedure for pesticides

Nine years after the adoption of Regulation (EC) No. 1107/2009 and following the recent controversy about the renewal of the active substance glyphosate, a special committee, the so-called ‘PEST’, was mandated in 2018 by the European Parliament for an analysis of the current authorisation procedure for pesticides in the Union. The final objective of the committee is to present recommendations on the procedure in order to achieve a high level of protection of human and animal health, and the environment.

A draft version of the PEST committee report has recently been made available online (please refer to the link below). A final version of the report is to be expected by the end of the year.

 

To download:

Draft report of the PEST Committee (25 August 2018)

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/