Extension of approval period for a number of active substances
Commission Implementing Regulation (EU) No. 1197/2012 amends Implementing Regulation (EU) No. 540/2011 with regard to the extension of the approval period of active substances. These substances are: acetamiprid, alpha-cypermethrin, Ampelomyces quisqualis Strain: AQ 10, benalaxyl, bifenazate, bromoxynil, chlorpropham, desmedipham, etoxazole, Gliocladium catenulatum Strain: J1446, imazosulfuron, laminarin, mepanipyrim, methoxyfenozide, milbemectin, phenmedipham, Pseudomonas chlororaphis Strain: MA 342, quinoxyfen, S-metolachlor, tepraloxydim, thiacloprid, thiram and ziram. Read the entire document here.
Changes to certain heading of Annex I to Directive 98/8/EC
The headings to all entries in Annex I of Directive 98/8/EC have been amended as follows:
- "Minimum degree of purity of the active substance" replaces "Minimum purity of the active substance in the biocidal product as placed on the market"
- "Deadline for compliance with Article 16(3), unless one of the exceptions indicated in the footnote to this heading applies" replaces "Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decision relating to its active substances)
The reasoning and justifications for these changes can be found in Commission Directive 2012/43/EU.
Two new inclusions and a non-inclusion in Annex I of the BDP
The European Commission has recently made several decisions with regard to biocidal active substances.
Bifenthrin will not be included in Annex I. The non-inclusion decision for product type 18 is Commission Decision 2012/728/EU.
Nonanoic acid is now also included for PT 2, according to Commission Directive 2012/41/EU.
Hydrogen cyanide has been approved for all three product types - PT 8 (wood preservatives), PT 14 (rodenticides) and PT 18 (insecticides, acaricides and products to control other arthropods) - through Commission Directive 2012/42/EU.
cis-Tricos-9-ene (PT 19) approved for inclusion in Annex I of 98/8/EC
The European Parliament and the EU Council have approved cis-Tricos-9-ene (PT 19) for inclusion in Annex I of Directive 98/8/EC. Certain provisions for the inclusion exist and can be read here:
Phosphane approved - Annex to Regulation No. 540/2011 amended
The new active substance phosphane has been approved in according with Regulation No. 1107/2009. The Anned to Regulation No. 540/2011 has been amended accordingly. The decision can be read here.
Isopyrazam approved according to Regulation 1107/2009
The European Commission has approved the active substance isopyrazam in accordance with Regulation 1107/2009. The Commission Regulation can be read here.
New Expiration Dates for a Number of Active Substances
Commission Regulation (EU) No. 823/2012, derogating from Implementing Regulation (EU) No. 540/2011 as regards the expiry dates of the approval of a number of active substances, has been published. The change in date relates to substances for which approval expires before 14 June 2014; applicants could not give the three year' notice required under Article 15(1) of Regulation 1107/2009. The entire regulation detailing the active substances involved can be read here.
New submission dates for certain substances
Commission Decision 2012/483/EU sets new dealines for the submission of dossiers for certain substances to be examined under Directive 98/8/EC (BDP). The following substances and product types are to be submitted by 30 September 2013:
Triclosan PT 2 RMS: DK
Triclosan PT 7 RMS: DK
Triclosan PT 9 RMS: DK
2-phenoxyethanol PT 3 RMS: UK
DDACarbonate for PT8 included in Annex I of 98/8
DDACarbonate has been approved for inclusion to Annex I of Directive 98/8/EC (BPD) for PT 8. Commission Directive 2012/22/EU can be read in its entirety here.
Conditions of Approval amended for several substances
Commission Implementing Regulation (EU) No. 637/2012 amends the conditions of approval of the active substance iron sulphate, repellents by smell of animal or plant origin/tall oil crude and repellents by smell of animal or plant origin/tall oil pitch. In light of current scientific and technical knowledge, it was necessary to amend the conditions of approval as follows:
Iron sulphate: Particular attention is to be paid to: risk for operator; risk to children/residents playing on treated turf; risk to surface waters and to aquatic organisms. Confirmatory information regarding equivalence between the specifications of the technical material as commercially manufactured and those of the test material used in the toxicity dossiers is to be submitted by 1 May 2013.
Repellents by smell of animal or plant origin/tall oil pitch and crude: Particular attention is to be paid to: protection of operator, worker and bystander; risk to non-target species. Confirmatory information regarding (a) equivalence between the specifications of the technical material as commercially manufactured and those of the test material used in the toxicity dossiers is to be submitted by 1 May 2013; (b) the toxicological profile of repellents by smell of animal or plant origin/tall oil crude is to be provided to the Commission by 31 May 2014.
The entire Regulation can be read here.
Flufenoxuron (PT8) approved in Annex I of 98/8/EU
The European Commission has approved Flufenoxuron for inclusion in Annex I of Directive 98/8/EC (Commission Directive 2012/20/EU) . The complete decision can be read here.
Regulation (EU) No. 528/2012 - Revised Biocidal Products Regulation
Regulation (EU) No. 528/2012 has been publisched by the European Union. This revised Regulation replaces the Biocides Products Directive (BPD) 98/8/EC and will take effect starting 1 September 2013.
The new Regulation can be read here. More information regarding this revised Regulation will be provided in upcoming SCC Newsletters.
Amendments to conditions of approval for aluminium silicate, hydrolysed proteins and 1,4-diaminobutane (putrescine)
Commission Implementing Regulation (EU) No. 571/2012 amends Reulgation 540/2011 with regards to the conditions of approval for the active substances aluminium silicate, hydrolysed proteins and 1,4-diaminobutane (putrescine). The new conditions can be read here.
Diphenylamine not approved
Diphenylamine, which was already not included under Annex I of Directive 91/414/EC, has once again failed to receive approval for placement on the market according to Regulation (EC) No. 1107/2009.
Decision 2009/859/EC already gave reasons for the non-inclusion of Diphenylamine. A new notifier made an application for the active substance to the Irish RMS. This new application was unable to eliminate concerns regarding metabolites and the presence of nitrosamines. For this reason, the active substance is not approved. Decision 2009/859/EC has been repealed and replaced by Commission Implementing Decision (EU) No. 578/2012.
An important sidenote: The Regulation does not prohibit or prejudice the submission of a further application for diphenylamine pursuant to Article 7 of Regulation (EC) No. 1107/2009.
MRLs for a number of substances amended
Commission Regulation (EU) No. 441/2012 amends Annexes II and III to Regulation (EC) No. 396/2005 regarding MRLS. The active substances involved are:
Bifenazate, Bifenthrin, Boscalid, Cadusafos, Chlorantraniliprole, Chlorothalonil, Clothianidin, Cyproconazole, Deltamethrin, Dicamba, Difenoconazole, Dinocap, Etoxazole, Fenpyroximate, Flubendiamide, Fludioxonil, Glyphosate, Metalaxyl-M, Meptyldinocap, Novaluron, Thiamethoxam, Triazophos
Authorisation restrictions for biocidal products containing Difethialone
Denmark, Germany and Sweden have issued restrictions for biocidal products containing Difethialone. The restrictions are as follows:
Restricted to use by trained professionals with a license (Commission Implementing Decision 2012/318/EU)
Restricted to use by licensed or trained professionals (Commission Implementing Decision 2012/317/EU)
Restricted to use by trained professionals with a license (Commission Implementing Decision 2012/316/EU)
Non-Inclusion of Naled in BPD
Commission Decision 2012/257/EU concerning the non-inclusion of Naled for product type 18 in Annex I of the BPD Directive (98/8/EC) was published on 11 May 2012. Biocidal products of this product type containing Naled can no longer be placed on the market after 1 November 2012.
Inclusions and non-inclusions to the BPD
Three active substances have been included in Annex I of the BPD. These are:
- Methyl nonyl ketone - Commission Directive 2012/14/EU
- Margosa extract - Commission Directive 2012/15/EU
- Hydrochloric acid - Commission Directive 2012/16/EU
In addition, the decision was made not to include the following active substance in Annex I of the BPD:
- Dichlorvos - Commission Decision 2012/254/EU
Amendments to conditions of approval for a number of active substances
Commission Implementing Regulation (EU) No. 369/2012 amends the conditions of approval for blood meal, calcium carbide, calcium carbonate, limestone, pepper and quartz sand. It was deemed appropriate to require further confirmatory information for these substances. In addition, certain technical adaptations are to be made, in particular the name of the active substance "pepper" should be replaced by "pepper dust extraction residue". A reasonable period of time will be given to meet the requirements resulting from the amendment to the conditions of approval.
Novaluron withdrawn from evaluation process
Novaluron, a new active substnace that was under preliminary examination by the Commission and Member States, has been withdrawn by the notifier from the evaluation process. Existing provisional authorizations are to be withdrawn and no new authorizations granted. The effective date for withdrawal of the authorizations is 3 October 2012. The Commission Implementing Decision 2012/187/EU can be read here.
Commission Decision 2012/78/EU - Non-inclusion of substances in Annex I of 98/8/EC
Commission Decision 2012/78/EU concerning the non-inclusion of certain substances in Annex I of the BPD has been published. A number of substances/product types will be removed from the list.
A number of participants either discontinued their participation in the review program, or no complete dossier was received within the time period specified. In addition a number of companies indicated an interest in taking over the role of participant for certain substances/product types. However, they subsequently failed to submit complete dossiers.
The complete list of non-inclusions can be read in the Decision here. The Status of Annex I, 98/8/EC on the SCC website has also been updated to reflect these non-inclusions.