Propanil receives non-approval
The active substance propanil, which was withdrawn under 2008/769/EC and resubmitted under the accelerated procedure, has received a non-approval according to Regulation (EC) No. 1107/2009. Commission Implementing Regulation (EU) No. 1078/2011 can be read here.
Commission Implementing Regulation (EC) No 993/2011 approves the active substance 8-hydroxyquinoline in accordance with Regulation (EC) No 1107/2009, amending the Annex to Commission Implementing Regulation (EU) No 540/2011. Under the stage three requirements according to Regulations 451/2000 and 1490/2002, no complete dossier was submitted within the prescribed time limit. The original notifier then submitted a new application for approval under the accelerated procedure.
The active substance is approved for uses as a fungicide and bactericide in greenhouses.
The complete Regulation can be read here: Commission Implementing Regulation (EC) No 993/2011
New additions to Annex of Commission Implementing Regulation (EU) No. 540/2011
Six substances have been added to the Annex of Commission Implementation Regulation (EU) No. 540/2011. Four were re-submitted after withdrawal under Decision 2008/934/EC and Decision 2009/860/EC, respectively. The Substances and their associated regulations are shown below:
New active substances:
Spiroxamine - Commission Implementing Regulation (EU) No. 797/2011
Kresoxim-methyl - Commission Implementing Regulation (EU) No. 810/2011
Re-submissions after withdrawal:
Oxyfluorfen - Commission Implementing Regulation (EU) No. 798/2011
Tefluthrin - Commission Implementing Regulation (EU) No. 800/2011
Fluquinconazol - Commission Implementing Regulation (EU) No. 806/2011
Triazoxide - Commission Implementing Regulation (EU) No. 807/2011
Provisional authorizations extended for new actives
The European Commission has extended the provisional authorizations for nine new active substances currently under review in Commission Implementing Decision 2011/490/EU. These are:
Adoxophyes orana granulovirus
BPD amended to include Creosote
Creosote (PT 8 - wood preservatives) has been approved for inclusion onto Annex I of Directive 98/8/EC (BPD). Because of concerns raised in the risk assessments, the inclusion is limited to five years starting 01 May 2013. Commission Directive 2011/71/EU details the requirements and considerations of the inclusion.
Fluroxypyr - Registered under Regulation (EU) No. 540/2011
Fluroxypyr, originally listed in Annex I of Direcitve 91/414/EEC, has now had its registration renewed. It has now been added to the Annex of Commission Implementing Regulation (EU) No. 540/2011. (See Regulation (EU) No. 736/2011 for details).
Fluroxypyr is authorized for use as a herbicide.
Dicloran and Flurprimidol out of Annex I
Dicloran and Flurprimidol are out of Annex I of Directive 91/414/EEC. The substances were originally voluntarily withdrawn and then resubmitted for evaluation under the accelerated procedure. The review lead to the conclusions that the substances should not be listed in Annex I.
Non-inclusion Decision for Propisochlor
The European Commission has decided against an inclusion of Propisochlor in Annex I of Council Directive 91/414/EEC. Withdrawn under Commssion Decision 2008/941/EC, it was re-submitted for evaluation according to the accelerated procedure; however, the concerns raised by the Member states could not be eliminated through the new data submitted and arguments made by the applicant. For this reason, it was not approved for inclusion - Commission Decision 2011/262/EU.
Two actives included in Annex I
Cyproconazole and Fluometuron have been added to Annex I of Directive 91/414/EEC. They were withdrawn under Commission Decision 2008/934/EC and re-evaluated under the accelerated procedure.
Cyproconazole - Commission Directive 2011/56/EU - only uses as a fungicide may be authorized.
Fluometuron - Directive 2011/57/EU - only uses as herbicide on cotton may be authorized.
Paclobutrazol added to Annex I
Commission Directive 2011/55/EU is concerned with the inclusion of Paclobutrazol onto Annex I of Directive 91/414/EEC. The active was re-evaluated under the accelerated procedure after having been withdrawn under Commission Decision 2008/934/EC. The active is only authorized for uses as a plant growth regulator.
Three actives included onto Annex I of 91/414/EEC
The European Commission has approved the inclusion of three additional active substances onto Annex I of 91/414/EEC. They are as follows:
Carboxin - Commission Directive 2011/52/EU - authorized for uses as fungicide for see treatment only
Dazomet - Commission Directive 2011/53/EU - authorizations only for uses as nematicide, fungicide and insecticide. Application as soil fumigant only may be authoirzed. Use shall be limited to one application every third year.
Metaldehyde - Commission Directive 2011/54/EU - only uses as molluscicide may be authorized.
Another active substance approved for Annex I of 91/414/EEC
Carbetamide has been approved for inclusion in Annex I of 91/414/EEC (Commission Directive 2011/50/EU). This is a reversal of Decision 2008/934/EC, which withdrew carbetamide from the evaluation process. The active was re-evaluated under the accelerated process. It is only authorized for use as a herbicide.
Pencycuron included in Annex I of 91/414/EEC
Another active substance withdrawn under Commission Decision 2008/934/EC has been re-evaluated under the accelerated procedure and included in Annex I of Directive 91/414/EEC: Pencycuron, Commission Directive 2011/49/EU, which can only be auhorized for use as a fungicide.
Aluminium Sulphate and Bromadiolone included in Annex I of 91/414/EEC
Two stage 4 actives that were withdrawn under Commission Decision 2008/941/EC have been re-evaluated under the accelerated procedure and are now approved for inclusion to Annex I of Directive 91/414/EEC. They are:
Aluminium Sulphate - Commission Directive 2011/47/EU - only indoor uses as post-harvest bactericide for ornamental plants may be authorized.
Bromadiolone - Commission Directive 2011/48/EU - Authorizations for uses by professional users only. Only uses as rodenticide in the form of pre-prepared baits placed into the rodent tunnels may be authorized.
Hexythiazox in Annex I of Directive 91/414/EEC
Hexythiazox has been included in Annex I of Directive 91/414/EEC under Commission Directive 2011/49/EU. Re-evaluated under the accelerated procedure, it is authorized only for uses as an acaricide.
Three inclusions to Annex I of 91/414/EEC
Lime sulphur, Azadirachtin and Diclofop have been included onto Annex I of 91/414/EEC. All three substances were originally wihdrawn from the review process and were listed as non-inclusions in Commission Decision 2008/941/EC. After resubmission under the accelerated procedure according to Commission Regulation (EC) No. 33/2008, the three actives have achieved inclusion.
Lime sulphur - Commission Directive 2011/43/EU - only uses as fungicide authorized
Azadirachtin - Commission Direcetive 2011/44/EU - only uses as insecticide authorized
Diclofop - Commission Directive 2011/45/EU - only uses as herbicide authorized
Non-inclusion in Annex I of 91/414/EEC: Dichlobenil
Dichlobenil, withdrawn under Commission Decision 2008/754/EC, was re-evaluated under the accelerated procedure according to Commission Regulation No. 33/2008. The EU Commission has issued a non-inclusion decision (Commission Decision 2011/234/EU), which concerns the non-inclusion of Dichlobenil after the new evaluation.
Four additional inclusions to Annex I of 91/414/EEC
Four additional actives have been added to Annex I of 91/414/EEC. The active substances and their decisions are listed below:
Fenazaquin - Commission Directive 2011/39/EU - authortized for use as acaracide on ornamentals in greenhouses
Sintofen - Commission Directive 2011/40/EU - authorized for uses as a plant growth regulatory on wheat for hybrid seed production not intended for human consumption.
Dithianon - Commission Directive 2011/41/EU - authorized for uses as fungicide only.
Flutriafol - Commission Directive 2011/42/EU - authorized for uses as fungicide only.
Eleven additions and one exclusion to Annex I of Directive 91/414/EEC
The European Commission has issued a number of decisions regarding the inclusion of 11 active substances and 1 non-inclusion to Annex I of Directive 91/414/EEC. The inclusions are as follows:
The non-inclusion involves Ethoxyquin, which is not included according to Commission Decision 2011/143/EU.
Another extension to Decision 2009/251/EC concerning dimethylfumarate (DMF)
Commission Decision 2009/251/EC, ensuring that products containing the biocide dimethylfumarate (DMF) are not placed or made available on the market, was valid for one year and could be extended in additional periods not exceeding one year. Because no permanent measure addressing consumer products containing DMF was approved, Commission Decision 2010/153/EU extended this period to 15 March 2011.
Commission Decision 2011/135/EU once again extends the validity of Decision 2009/251/EC for an additional year to 15 March 2012. This is because there is an absence of a permanent measure addressing consumer products containing DMF.
Commission Regulation 188/2011
Commission Regulation (EU) No 188/2011 lays down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive. It was necessary to adopt rules on a procedure for the submission and appraisal of applications for inclusion in Annex I to Directive 91/414/EEC of active substances which were not yet on the market 2 years after the date of notification of that Directive. In particular, periods needed to be set for the different steps of that procedure to ensure that they would be carried out rapidly. It deals specifically with active substances which were not on the market on 26 July 1993.
The complete Regulation can be read here: Commission Regulation (EU) No 188/2011
Profoxydim added to Annex I
The European Commission has voted to include the new active substance Profoxydim to Annex I of Directive 91/414/EEC. It is authorized only for use as a herbicide in rice. The Directive can be read here:
Commission Directive 2011/14/EU
Four actives added to Annex I of 98/8/EC (BPD)
Four active substances have been added to Annex I of Directive 98/8/EC (Biocidal Products Directive - BPD). They are:
- Bifenthrin - PT 8 (wood preservatives) - Directive 2011/10/EU
- (Z,E)-tetradeca-9,12-dienyl acetate - PT 19 (repellents and attractants) - Directive 2011/11/EU
- Fenoxycarb - PT 8 (wood preservatives) - Directive 2011/12/EU
- Nonanoic acid - PT 19 (repellents and attractants) - Directive 2011/13/EU
Dodine added to Annex I of Directive 91/414/EEC
Dodine, originally withdrawn through Directive 2008/934/EC from the evaluation process under Directive 91/414/EEC, has now won approval for inclusion to Annex I. The resubmitted dossier was evaluated under the accelerated procedure. Dodine is authorized only for use as a fungicide.
1,3-dichloropropene again a non-inclusion
The re-submission of 1,3-dichloropropene for inclusion in Annex I to Council Directive 91/414/EEC failed to gain approval of the European Commission. Commission Decision 2011/36/EU details the decision process involved after 1,3-chloropropene was resubmitted under the accelerated procedure. Concerns for consumer exposure in relation to 11 unidentified manufacturing impurities and the potential contaminiation of groundwater due to its breakdown product and the unidneitifed manufacturing impurities were specific concerns noted in the non-inclusion decision. The complete decision can be read here: Commission Decision 2011/36/EC.
Three non-inclusion decisions revised after review under "accelerated procedure"
Buprofezin, Hymexazol and Cycloxydim have been approved for inclusion to Annex I of Directive 91/414/EEC after review under the "accelerated procedure" (Commission Regulation (EC) 33/2008).
Buprofezin is included under Directive 2011/6/EU and can be authorized for uses as an insecticide and as an acaricide. Hymexazol, Directive 2011/5/EU, is authorized for uses as fungicide for seed pelleting of sugar beets in professional see treatment facilities only. Last but not least, Cycloxydim is authorized for use as a herbicide only under Directive 2011/4/EU.
The inclusion Directive can be viewed under Annex I, 91/414/EEC on the SCC website or, alternatively, here:
Commission Directive 2011/6/EU: Buprofezin
Commission Directive 2011/5/EU: Hymexazol
Commission Directive 2011/4/EU: Cycloxydim
Vitamin E - Re-authorization as feed additive
Vitamin E is the first feed additive to be re-authorized under Regulation (EC) No 1831/2003. It is authorized for use for all animal species. The forms of Vitamin E authoried are:
1. all-rac-α-tocopheryl acetate
2. RRR-α-tocopheryl acetate
The inclusion regulation can be read here: Regulation (EC) No 26/2011
Non-inclusion Decisions Reversed for 6-Benzyladenine and Myclobutanil
The European Commission has ammended Council Directive 91/414/EEC to include 6-Benzyladenine and Myclobutanil, reversing their non-inclusion Decisions from 2008. 6-Benzyladenine, a 4th stage active, may only be authorized for uses as a plant growth regulator. Myclobutanil, a stage 3 active, may only be authorized for use as fungicide. The two inclusion Directives can be read here:
Commission Directive 2011/1/EU
Commission Directive 2011/2/EU
Bromuconazol added to Annex I
Bromuconazol has been included in Annex I after review under the accelerated program. Only uses as a fungicide may be registered. Read here: Directive 2010/92/EU.