New deadlines for the submission of dossiers

17.12.2007
For existing biocidal active substances of the second priority list (PT 18 and 19), which were taken over by other participants, the Commission has recently set a legally binding new deadline by which dossiers will have to be submitted.

The substances concerned are

Azamethiphos PT 18
Carbon dioxide PT 19
Diazinon PT 18
Fenitrothion PT 18
Geraniol PT 18 and 19
Hydramethylnon PT 18
Linalool PT 19
Methyl anthranilate PT 19
Oct-1-ene-3-ol PT 19
Propoxur PT 18
Pyrethrins and Pyrethroids PT 19

The deadline by which dossiers must be submitted in the respective Product types at the latest, was set to 30 April 2008.

To read more, here is the direct link to Commission Decision 2007/794/EC of 29 November 2007 as published in the Official Journal of the European Union:

EU Decision 2007/794/EC

 

New Review Regulation published in the official Journal

17.12.2007
Commission Regulation (EC) No 1451/2007 was published in the Official Journal of the European Union on 11 December 2007. This so called “New Review Regulation” repeals Regulation (EC) No 2032/2003 (Second Review Regulation), which has been amended several times.

In short, the New Review Regulation establishes consolidated lists of biocidal active substances, it provides refined rules regarding the process of taking over the role of a participant and it lays down the exemption of food and feed from the scope of the Biocidal Products Directive 98/8/EC.

To read the full text of the regulation, click here.

 

New Service at SCC Available - Feed Additives

12.11.2007
The new Regulation laying down guidelines concerning applications for authorisation of additives for use in animal nutrition (replacement of Annexes of Council Directive 87/153/EEC, amended by Commission Directive 2001/79/EC), will be finalised in the second half of the year 2007. Herewith a positive list will be established of feed additives in accordance with Regulation (EC) No 1831/2003 of the European Parliament and of the Council. Existing additives have to be re-evaluated according to these new guidelines and new additives have to follow these guidelines to become authorised.

SCC has acquired a wealth of experience in the notification of substances to regulatory authorities within the EU. Our experience is your advantage!

Let SCC take care of your regulatory needs. If you want your feed additives on the market as soon as possible and have no intention of spending your resources on dealing with authorities and the management of regulatory data generation, let us take care of the legal aspects, directives, forms and regulatory procedures.

The feed additives brochure can be found on our website along with all other brochures outlining SCC's services. Contact Ruud Huibers for more information.

 

 

Information regarding Formaldehyde / New Competent Authority Reports / Assessment Reports Available

26.10.2007
Formaldehyde (CAS-no. 50-00-0) is an important basic chemical substance and is a part of a variety of industrial products of our everyday’s life, such as glues and adhesives, resins, paper coatings or textile finishing. Because of its remarkable biocidal properties, formaldehyde is also used as an in-can preservative for paints or cosmetics, as a disinfectant or as the antiseptic component in embalming fluids.

In the framework of the biocides review programme, formaldehyde was originally notified in 15 different product types by a consortium called FAREG. FAREG (formaldehyde registration group) was formed by some producers and users of formaldehyde as another sector group under the roof of CEFIC. FAREG’s objective was to gather all necessary information and scientific studies enabling the submission of a dossier to comply with the requirements for Annex 1 inclusion under the terms of Biocidal Products Directive 98/8/EC.

Germany was allocated as Rapporteur Member State for formaldehyde in the biocides review programme. However, on 22 June 2007 a withdrawal notice was published by the Commission stating that formaldehyde was completely withdrawn from the review programme. Financial implications were certainly one of the reasons which made FAREG withdraw the substance. Due to a special fee structure for the evaluation of existing biocidal actives in Germany, the applicant would have been obliged to pay a total of more than 1 million EUR just for fees for formaldehyde in all notified product types.

Independent from the developments in the area of biocides regulatory affairs, formaldehyde hit the headlines in 2004, when the International Agency for Research on Cancer (IARC, a part of the World Health Organisation, WHO) came to the conclusion that formaldehyde should be classified as carcinogenic to humans. However, this scientific opinion has been much disputed since it was published. The most recent research work done on the field of epidemiology and toxicology of formaldehyde indicates, that the substance is unlikely to pose such a high risk to human health.

On 1 October 2007 the Commission published a notice, that several companies intend to take over the role of participant for formaldehyde in altogether 10 product types. A new deadline for dossier submission will be confirmed in a forthcoming Regulation. Eagles live longer. To be continued.


New Competent Authority Reports / Assessment Reports published online

On 27 September 2007 the CA report on Sulfuryl fluoride for use in product type 18 (Insecticides, acaricides and product to control other arthropods) was published online. This is the first PT18 CA report published. It can be downloaded via the following link:

http://circa.europa.eu/Public/irc/env/bio_reports/library?vm=detailed&sb=&l=/review_programme/ca_reports/pt18_insecticides

The RMS Sweden proposes Sulfuryl fluoride to be included in Annex I to the Directive 98/8/EC as an active substance in product type 18.


New CA reports / assessment reports on the active substances Alkyldimethylbenzylammonium Chloride (ADBAC), Chlorfenapyr, Dazomet and Didecyldimethylammonium Chloride (DDAC) were published online and can be downloaded via the following link:



New CA reports / assessment reports on the active substances Alkyldimethylbenzylammonium Chloride (ADBAC), Chlorfenapyr, Dazomet and Didecyldimethylammonium Chloride (DDAC) were published online and can be downloaded via the following link:

http://circa.europa.eu/Public/irc/env/bio_reports/library?vm=detailed&sb=&l=/review_programme/ca_reports/wood_preservatives

The four actives are recommended to be included in Annex I to the Directive 98/8/EC by the respective RMS.

For proposed conditions and restrictions regarding the Annex I inclusions of the active substances, please refer to the relevant sections of the CA reports.

 

 

 

 

Status of 91/414/EEC Inclusions

18.09.2007

The current status of Annex I inclusions for existing substances according to 91/414/EEC is shown below. Of the 1009 substances, 91 active substances, representing 9% of the total, are included in Annex I, 320 are pending, and 598 are not included.

Registration of Feed Additives

17.09.2007

Council Directive 87/153/EEC of 16 February 1987 fixing guidelines for the assessment of additives in animal nutrition, last amended by Commission Directive 2001/79/EC of 17 September 2001.

In the second half of 2007 the European Commission will finalise a new Regulation to establish implementing rules and guidelines concerning applications for authorisation of feed additives submitted in accordance with Article 7, paragraph 4 of Regulation (EC) No 1831/2003. These rules include requirements on the preparation and the presentation of such applications and guidelines for the assessment and authorisation of the additives subject to those applications. This new Regulation shall replace the Annexes of the Directive 87/153/EEC.

Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition.

This Regulation has replaced the former Council Directive 70/524/EEC concerning additives in feedingstuffs. Also based on Regulation (EC) No 178/2002, an overall review of all the rules on additives for use in animal nutrition was necessary. Article 7 of this Regulation is laying down procedures for application for authorisation of additives for use in animal nutrition.

 

Other important EU-Laws for animal nutrition:

16.09.2007

Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene.

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance   with feed and food law, animal health and animal welfare rules.

Regulation (EC) No 187/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.

SCC Opens Liaison Office in Japan

19.07.2007

SCC announces the establishment of the SCC Liaison Office Japan. Operation began on 16 July 2007.

SCC's regulatory services in the fields of agrochemicals, chemicals/consumer goods, biocides and pharmaceuticals will significantly improve to benefit Japanese companies with current and/or future business plans overseas (especially in the EU), or others who want to obtain approvals for their products in Japan.

Mr. Norio Ohta, Director, and Mr. Kenji Makita, Senior Consultant, bring with them many years of experience in regulatory work.

The SCC Liaison Office Japan is located at:

134-5, Mimuro, Midori-ku, Saitama-shi,
Saitama 336-0911, Japan

The office is approximately 1.5 hours by train from the Tokyo Station.

Contact details for Mr. Ohta and Mr. Makita are:

Mr. Norio Ohta, Director
Phone/Fax: ++81 (0)48-873-6355
E-Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
or for Japanese correspondence:
This email address is being protected from spambots. You need JavaScript enabled to view it.
Mobile: ++81 (0)80-3381-8903

Mr. Kenji Makita, Senior Consultant
Fax.: ++81 (0)3-3223-3478
E-Mails: This email address is being protected from spambots. You need JavaScript enabled to view it.
or for Japanese correspondence:
This email address is being protected from spambots. You need JavaScript enabled to view it.
Mobile: ++81-(0)90-3686-5262

Feel free to contact them directly in order to obtain information on SCC's improved regulatory services. We would be more than pleased to either continue with services for you or to start new ones upon your request.

 

Status of 91/414/EEC Inclusions - New Substances

05.03.2007

The current status of new active substance inclusions according to 91/414/EEC is as follows:
Table 4: Annex I Inclusions, New Active Substances (74 actives)

1-Methyl-cyclopropene
Flazasulfuron
Oxadiargyl
Acetamiprid
Florasulam
Oxasulfuron
Acibenzolar-S-methyl
Florchlorfenuron
Paecilomyces fumosoroseus
Ampelomyces quisqualis
Flufenacet (formerly fluthiamide)
Pethoxamide
Azimsulfuron
Flumioxazine
Picolinafen
Azoxystrobin
Flupyrsulfuron methyl
Picoxystrobin
Bacillus subtilis str. QST 713
Flurtamone
Prohexadione calcium
Beflubutamid
Foramsulfuron
Propoxycarbazone
Benzoic acid
Fosthiazate
Prosulfuron
Bifenazate
Gliocladium catenulatum strain J1446
Pseudomonas chlororaphis
Carfentrazone-ethyl
Imazamox
Pymetrozine
Cinidon ethyl
Imazosulfuron
Pyraclostrobin
Clothianidin
Indoxacarb
Pyraflufen-ethyl
Coniothyrium minitans
Iodosulfuron-methyl-sodium
Quinoxyfen
Cyazofamid
Iprovalicarb
Silthiofam
Cyclanilide
Isoxaflutole
S-Metholachlor
Cyhalofop-butyl
Kresoxim-methyl
Spinosad
Dimethenamid – P
Laminarin
Spiroxamine
Dimoxystrobin
Mepanipyrim
Sulfosulfuron
Ethoxysulfuron
Mesosulfuron
Tepraloxydim
Etoxazole
Mesotrione
Thiacloprid
Famoxadone
Metalaxyl-M
Thiamethoxam
Fenamidone
Methoxyfenozide
Trifloxystrobin
Fenhexamid
Metrafenone
Zoxamide
Ferric phosphate
Milbemectin
    

Table 5: Annex I Non-Inclusions, New Active Substances (7 actives)

Alanycarb
Azafenidin
Chlorfenapyr
Fluazolate (formerly isopropozole)
Flusulfamide
Pyridafol
Zucchini yellow mosaic virus (ZYMV mild strain)

 

Status of 91/414/EEC Inclusions - Existing Substances

05.03.2007

Here is the current status of the 91/414/EEC for existing substances:

Table 1: Stage 1 Annex I Inclusions, Existing Active Substances (60actives)

2,4-D
Dinocap
Mecoprop-P
2,4-DB
Diquat
Methamidophos
alpha-Cypermethrin
Esfenvalerate
Metiram
Amitrole (aminotriazole)
Ethofumesate
Metsulfuron
Azinphos-methyl
Fenarimol
Molinate
Benalaxyl
Fluroxypyr
Paraquat
Bentazone
Flusilazole
Pendimethalin
beta-Cyfluthrin
Glyphosate
Phenmedipham
Bromoxynil
Imazalil
Procymidone
Carbendazim
Ioxynil
Propiconazole
Chlorothalonil
Iprodione
Propineb
Chlorpropham
Isoproturon
Propyzamide
Chlorpyrifos
lambda-Cyhalothrin
Pyridate
Chlorpyrifos-methyl
Linuron
Thiabendazole
Chlortoluron
Maleic hydrazide
Thifensulfuron
Cyfluthrin
Mancozeb
Thiophanate-methyl
Cypermethrin
 Maneb
Thiram
Daminozide
MCPA
Triasulfuron
Deltamethrin
MCPB
Warfarin
Desmedipham
Mecoprop
Ziram

 


Table 2: Stage 1 Annex I Non-Inclusions, Existing Active Substances (30 actives)

Acephate
DNOC
Parathion-ethyl
Alachlor
Endosulfan
Parathion-methyl
Aldicarb
Fenthion
Permethrin
Amitraz
Fentin acetate
Propham
Atrazine
Fentin hydroxide
Pyrazophos
Azinphos ethyl
Fenvalerate
Quintozene
Benomyl
Ferbam
Simazine
Chlozolinate
Lindane
Tecnazene
Cyhalothrin
Metalaxyl
Vinclozolin
Dinoterb
Monolinuron
Zineb

 

Table 3: Stage 2 Annex I Inclusions, Existing Active Substances (24actives)
 

Captan
Folpet
Pyrimethanil
Clodinafop
Formetanate
Rimsulfuron
Clopyralid
Fosetyl
Tolclofos-methyl
Cyprodinil
Metconazole
Tolylfluanid
Dichlorprop-P
Methiocarb
Tribenuron
Dimethoate
Oxamyl
Triclopyr
Ethephon
Phosmet
Trinexapac
Fenamiphos
Pirimicarb
Triticonazole