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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: Updates of AIR 3 and AIR 4 working documents

AIR 3 programme

SANCO/2012/11284 – Rev. 21  – June 2018 – Draft working document – AIR III Renewal programme

This 21th revision contains new expiry dates set by Regulation (EU) 2018/524 of 28 March 2018 (Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, clodinafop, clopyralid, cyprodinil, dichlorprop-P, fosetyl, mepanipyrim, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, quinoxyfen, rimsulfuron, spinosad, thiacloprid, thiamethoxam, thiram, tolclofos-methyl, triclopyr, trinexapac, triticonazole and ziram) and Regulation (EU) 2018/917 of 27 June 2018 (alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, carvone, chlorpropham, cyazofamid, desmedipham, dimethoate, dimethomorph, diquat, ethephon, ethoprophos, etoxazole, famoxadone, fenamidone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, Gliocladium catenulatum strain: J1446, isoxaflutole, metalaxyl-m, methiocarb, methoxyfenozide, metribuzin, milbemectin, oxasulfuron, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, pymetrozine and s-metolachlor). It also contains the renewal of active substances (Ampelomyces quisqualis strain AQ10, carfentrazone-ethyl and trifloxystrobin).

 

AIR 4 programme

SANTE-2016-10616-rev 9 – June 2018 – AIR IV Renewal programme

SANTE-2016-11734-rev.10 –  June 2018 – AIR IV Renewal programme – Applications for renewal of approval submitted under article 14 of Regulation (EU) No. 1107/2009 and in accordance with Regulation (EU) No. 844/2012

These new versions update revision 8 of October 2017 and 9 of February 2018 of guidance documents SANTE-2016-10616 (AIR IV Renewal programme) and SANTE-2016-11734 (application overview for AIR IV substances).

 

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EUROPE: Updates of AIR 3 and AIR 4 working documents

AIR 3 programme

SANCO/2012/11284 – Rev. 20 – February 2018 – Draft working document – AIR III Renewal programme

This new revision contains new expiry dates for substances in batch 3 and batch 7 as set by Regulation (EU) 2018/84 (chlorpyrifos, chlorpyrifos-methyl, clothianidin, copper compounds, dimoxystrobin, mancozeb, mecoprop-p, metiram, oxamyl, pethoxamid, propiconazole, propineb, propyzamide, pyraclostrobin and zoxamide).

AIR 4 programme

SANTE-2016-11734–rev.9 – February 2018 – AIR IV Renewal programme – Applications for renewal of approval submitted under article 14 of Regulation (EU) No. 1107/2009 and in accordance with Regulation (EU) No. 844/2012

This new version updates revision 7 of October 2017.

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

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EUROPE: Updates of AIR 3 and AIR 4 Guidance documents

A number of SANCO and SANTE guidance documents have been updated:

 

AIR 3 programme

SANCO/2012/11284 – Rev. 19 – November 2017 – Draft working document – AIR III Renewal programme

The new revision contains new expiry dates for substances in batch 1, batch 2, batch 3, batch 5, 6, and 7.

Note that revision 19 replaces revision 18 that was uploaded prematurely by mistake. The extensions for batches 3 and 7 (all from 31.01.2018 to 31.01.2019) were deleted.

 

AIR 4 programme

SANTE-2016-10616–rev 8 – October 2017 – Draft working document – AIR IV Renewal Programme

The new revision shows the non-approval of tall oil pitch and tall oil crude, and the phase out of triflumizole and spirodiclofen (no applications received). A new page is added to the Working Document, with implementing Regulations (extensions).

SANTE-2016-11734–rev.7 October 2017 – AIR IV Renewal programme – Applications for renewal of approval submitted under article 14 of Regulation (EU) No. 1107/2009 and in accordance with Regulation (EU) No. 844/2012

This revision presents an overview of received applications, namely carbon dioxide (name change of the Carbon Dioxide Renewal Taskforce), cyflufenamid (applicant is Envigo, on behalf of Nisso Chemical Europe) and flonicamid (an application was received on 29.08.2017, name of the applicant not provided).

 

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EUROPE: AIR 3 working documents – Updates

The EU Commission has released 2 working documents regarding AIR 3 renewal programme:

 

  • SANCO/2012/11284 –rev. 17 (October 2016)

This new revision replaces Revision 14 dated December 2014. This document provides an overview of indicative submission dates for supplementary dossiers for the renewal of AIR 3 substances.

New expiry dates are given for:

batch 3.3: benzoic acid, flazasulfuron, mecoprop-p, mesosulfuron, propineb, propiconazole, propoxycarbazone, propyzamide, pyraclostrobin and zoxamide: 31.01.2018 (instead of 31.01.2017)

batch 3.4: acetamiprid, mepanipyrim, Pseudomonas chlororaphis strain MA 342, quinoxyfen and thiacloprid, thiram and ziram: 30.04.2018 (instead of 30.04.2017)

The extension for both Batches 3.3 and 3.4  was adopted and published in the Official Journal: Reg. (EU) 2016/2016 (November 2016).

It should be noted that several active substances were not supported (no supplementary dossier received although an application was made). As a consequence, the following expiry dates will apply:
– Mecoprop (batch 3.3): 31.01.2017
– Maneb (batch 3.7): 31.01.2017
– Fipronil (batch 3.9): 30.09.2017
– Chloridazon (batch 3.10): 31.12.2018

 

  • SANCO/10148/2014 – Rev. 10 (November 2016)

This new revision replaces Revision 6 (+ Revision 9, October 2016). This working document provides an update of applicants who supported AIR 3 active substances:

– name changes: Makhteshim -> Adama, Agriphar -> Arysta, Chemtura -> Arysta
– new co-applicant for dimethomorph (+ clomazone)
– no submission of the supplementary dossier for fipronil by BASF
– information added for applicants of diuron, clomazone, fludioxonil, prosulfocarb, tritosulfuron, amidosulfuron, bifenox, clofentezine, dicamba, difenoconazole, diflubenzuron, diflufenican, fenoxaprop-p, fenpropidin, lenacil, nicosulfuron, picloram, pyriproxyfen and quinoclamine (+  maleic hydrazide)

The working document states that no applications were received for chloridazon, imazaquin and oxadiazon. So far, only the non-application for chloridazon is reflected in SANCO/2012/11284 Rev.17.

To download:

SANCO/2012/11284 –Rev. 17, October 2016, Draft working document, AIR III renewal programme

SANCO/10148/2014 – Rev. 10, November 2016, Applications for renewal of approval of active substances submitted under article 14 of regulation (EU) N.o 1107/2009 and in accordance with regulation (EU) No. 844/2012

COMMISSION IMPLEMENTING REGULATION (EU) 2016/2016 of 17 November 2016 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances acetamiprid, benzoic acid, flazasulfuron, mecoprop-P, mepanipyrim, mesosulfuron, propineb, propoxycarbazon, propyzamide, propiconazole, Pseudomonas chlororaphis Strain: MA 342, pyraclostrobin, quinoxyfen, thiacloprid, thiram, ziram, zoxamide

 

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

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