Commission Decision 2010/675/EU: Non-inclusion of substances in Annex I
09.11.2010
The non-inclusion of certain subtances and product types in Annex I of the BPD - Commission Directive 98/8/EC is convered in the new Commission Decision 2010/675/EU. The list can be read in the Decision.
Tolylfluanid (PT 8) and Flocoumafen (PT 14) included in Annex I of BPD
30.11.2009
The EU Commission has approved two inclusions to Annex I of the BPD: Tolylfluanid (PT 8) and Flocoumafen (PT 14). The Directives for these inclusions can be found in SCC's table for Annex I inclusions of Biocidal Products.
EU Commission makes a number of Stage 3 and Stage 4 decisions
16.12.2008
Commission Directives 2008/934/EC, 2008/941/EC and 2008/113/EC have made some changes to the number of substances included and not included in Annex I of Directive 91/414/EEC. A total of 49 List 3 and 15 List 4 substances were eliminated through Directives 2008/934/EC and 2008/941/EC. Another List 4 substance, bone oil, was also voted as a non-inclusion.
Commission Directive 2008/116/EC included three List 3 existing actives: aclonifen, imidacloprid and metazachlor. 17 Microbiological substances out of List 4 are also inclusions to Annex I through Commission Directive 2008/113/EC.
To see the summary table and individual legislations, visit the SCC website - Status of Annex I 91/414/EEC.
Six more existing actives approved for Annex I
27.11.2008
The EU Commission has approved six more existing actives for Annex I listing in Directive 91/414/EEC. These are the third stage actives flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat. This brings the total number of existing active substances included in Annex I to 120.
EU Commission approves five actives for Annex I inclusion
26.11.2008
The EU Commission has approved five 3rd stage actives for inclusion onto Annex I of Directive 91/414/EEC: abamectin, epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim. Please refer to the SCC Website - Annex I inclusion list for the current status of Annex I inclusions.
Commission decides on five further substances for 91/414/EEC
02.10.2008
Five additional actives have been voted for non-inclusion in Annex I of 91/414/EEC. These are
Beauveria brongniartii
potassium permanganate
propanil
tricyclazole
buprofezin
Please refer to SCC's Anenx I listing for 91/414/EEC to find the details concerning these non-inclusions.
New Decisions for 91/414/EEC
01.10.2008
The European Commission has made decisions on four active substances: methyl bromide, dichlobenil, dicofol and diuron. Diuron, a stage two active, was originally non-included, but the notifier re-submitted the application in 2007, prior to the effective date of Commission Regulation 33/2008. Based on the new data presented, inclusion was approved.
The other three actives were not included in Annex I.
Please refer to SCC's comprehensive list regarding Annex I inclusions on the SCC website.
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 everydays 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. FAREGs 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
New SCC brochures available as download
30.10.2006
Eight new brochures are available as downloads, each describing all facet of SCC's services. The brochures discuss SCC's services in Agrochemicals, Biocides, Chemicals and Consumer Products, Pharmaceuticals, Regulatory Science, REACH, GLP and Regulatory Archiving and GIS.
SCC at BCPC Conference in Glasgow
11.10.2006
Once again, SCC will participate in the BCPC Conference in Glasgow, Scotland from 23 through 25 October. This is your chance to meet with Dr. Albrecht Heidemann and Dr. Monika Hofer to discuss your needs in Agrochemicals, Biocides and Chemicals with regard to new active substance dossiers, Annex III dossiers for existing substances, biocidal dossiers and REACH.
An added highlight this year will be on Tuesday evening, 24 October at 6:00 PM. SCC will sponsor a wine tasting event at the Pentagon Centre, 36 Washington Street. Come by and meet with SCC and enjoy a relaxed evening of conversation along with wines from the Rheinhessen region of Germany, home to SCC.
German State Ministry with Information about REACH
23.08.2006
The Ministry of Environment, Forests and Consumer Protection in the German state of Rheinland-Pfalz has relaunched their website to include information about REACH.
Under the left-hand navigation, the REACH information can be accessed under the link "Verbraucherschutz", "Chemikaliensicherheit" and then "REACH-Verordnung". In this information, SCC is included as a consultant to assist in the preparation of REACH documentation.
For more information, contact Dr. Werner Köhl at This email address is being protected from spambots. You need JavaScript enabled to view it.
SCC at IUPAC Conference in Kobe, Japan
18.07.2006
SCC GmbH will be at the IUPAC Conference in Kobe, Japan from 6 - 10 August. Dr. Friedbert Pistel and Horst D. Neufurth will be on hand to meet with you to discuss your specific regulatory and scientific needs in the areas of plant protection, biocides and chemicals.
On Tuesday evening, 8 August, SCC will sponsor a Wine Event at the IUPAC Conference. Wines from the Rheinhessen area will be served along with light snacks. Come to the MATSU Meeting Room at the Portopia Hotel between 6 and 9 PM for a chance to meet with Dr. Pistel and Mr. Neufurth, and for a taste of Germany.
REACH gains approval in EU
14.12.2005
The EU Council has reached political agreement on a comprehensive new system aimed at ensuring greater safety in the manufacture and use of chemical substances. The new system, REACH, will establish an integrated system for the registration, evaluation, authorisation and restriction of chemicals.
It is expected that the final decision on REACH will be reached by the European Parliament and Council in autumn 2006. The Commission expects entry into force of the Regulation for spring 2007. Thereafter it will take about a year for the REACH Agency to be operational. Accordingly the operational requirements of REACH are expected to start to be applied from 2008 onwards.
List of active substances and notifiers for New Member States available
24.11.2005
The list of active substances and notifiers for which a notification in accordance with Article 4 of Commission Regulation (EC) No. 2229/2004 has been submitted, is now available. These actives were notified by New Member States. The corresponding RMS is also given.
EFSAs Scientific Committee proposes harmonisation
07.11.2005
In an opinion published by EFSA, they propose a harmonised and transparent scientific approach for the risk assessment of substances which have both genotoxic and carcinogenic properties.