B-form: Information on the chemical biocidal product

B-form:Information on the chemical biocidal product

All the points in the form should be filled with information. In cases where the data requirement is not covered by a study/report, a detailed justification should be given.
Further information can be found in the Technical Notes for Guidance (TNsG) on Data Requirements. Consider in particular chapter 2 and 3 (Common core data set for active substances and biocidal products), Part B (Biocidal products).
For guidance on exposure estimates for livestock, see the guidance document "Guidance on Estimating Livestock Exposure to Active Substances used in Biocidal Products" which is available via the European Commission's website for biocidal products (DG Environment). For guidance on the assessment of MRLs (Maximum Residue Limits) please refer to the guidance document "Risk characterisation and assessment of Maximum Residue Limits (MRLs) for Biocides" at the European Medicines Agency’s (EMA) website.
If you have questions, please contact the Swedish Chemicals Agency at:
Point / Data requirement / Information/value / Reference to the application / Reference in the TNsG on Data Requirements

B1. General information

B1.1 / Name of the product
B1.2 / Product manufacturer
State name or company
B1.3 / Production plant(s)
State address(es) of all production plants

B2. Specific information on the product Chapter 2, part B

B2.1 / Active substance(s) in the product
State chemical name of each active substance in the product
B2.2 / Physical state of the product
State the formulation type according to GIFAP-codes. See table B in the end of this document
B2.3 / Detailed quantitative and qualitative information on the composition of the product
Fill in the quantitative and qualitative information on the composition of the product. State active substance(s), impurities, adjuvants, inert ingredients etc. State for each constituent an unambiguous chemical name according to ISO and/or IUPAC nomenclature as well as the CAS-No and/or EC-No. The exact content of each constituent shall be provided in % (w/w). The composition of the whole product must be given up to 100 %. Note, if any ingredient is a preparation, full qualitative and quantitative specification of this preparation must be given. State also the function of the ingredients (active substance, solvent, stabiliser etc). In cases of variations in composition of a single ingredient (e.g. petroleum fractions) intervals for the other chemical substances in the product shall also be stated. State also the CLP classification (or according to KIFS 2005:7) for every ingredient included in the formulated product. / 2.2
Ingredient
ISO/IUPAC-name / CAS No / EC No / Content
% (w/w) / Function of ingredient
Active substance, solvent, stabiliser etc. / Classification According to CLP (or KIFS 2005:7)
Point / Data requirement / Information/value / Reference to the application / Reference in the TNsG on Data Requirements

B3. Intended use of the product

The intended use, dose and application method for the product must correspond with the risk assessment of the product
B3.1 / Product type
State product type (according to appendix 9 of KIFS 2008:3)
B3.2 / Intended use of the product
State intended use of product, for example “against ants outdoors”
B3.3 / Intended user
State whether the product should be used professionally or by amateurs (private users)
B3.4 / Dose
State recommended dose, e.g. the amount of active substance per unit area and expected applications per day. If the product is formulated as napkins, fly paper etc, state the amount of active substance per unit
B3.5 / Application method
State application method, use intervals and duration of application. State working pressure and spray type for spray products
B3.6 / Miscibility
Provide information on the product’s miscibility and incompatibility with other pesticides or substances. If the product is recommended for dispersal together with other pesticides, these have to be stated separately
B3.7 / Efficacy, etc.
Information from practical experiments (tests, field trials etc) showing that the product has efficacy for the intended use. State also resistance-generatinproperties
B3.8 / Leaching rate
Fill in for the product types 8 (wood preservatives) and 21 (antifouling products).Shall include data about the active substances, leaching rate per area unit / volume unit at intended use
B3.9 / Need for the product
Give a statement of the need for the product

B4. Proposed classification, labelling and packaging

Label and instructions for use must reflect the intended use and risk assessment of the product
B4.1 / Proposed text for label in Swedish including risk information and safety advice as well as classification and labelling of the product
State proposed text in Swedish for label including risk information and safety advice as well as other prescribed label text and symbol, if any, (KIFS 2008:3). A draft label should be enclosed
B4.2 / Proposed instructions for use
A draft instructions for use should be enclosed
B4.3 / Package material and size
State package material, type (barrel, bottle, bag etc.), size (state volume for liquids, weight for others)

B5. Toxicological properties of the productChapter 2, part B

B5.1 / Acute oral toxicity / 6.1.1
Animal species
LD50 (mg/kg)
Observed effects, organ injuries etc.
B5.2 / Acute dermal toxicity / 6.1.2
Animal species
LD50 (mg/kg)
Observed effects, organ injuries etc.
B5.3 / Acute inhalation toxicity / 6.1.3
Animal species
LC50 (mg/L)
Observed effects, organ injuries etc.
B5.4 / Skin irritation / 6.2
B5.5 / Eye irritation / 6.2
B5.6 / Skin sensitisation / 6.3
B5.7 / Dermal absorption of the formulation (%) / 6.4
B5.8 / Other available toxicological data on the formulation
State repeated dose studies and exposure patterns: oral, dermal, inhalation
B5.9 / Available toxicological data on the non-active substances
For example substances of concern relevant for the toxicological properties and classification of the product / 6.5

B6. Residue data for the productin exposed food, feeding stuffs Chapter 3, part Aor on livestock that will be used for food manufacturing industry

For products that will be used in e.g. storage spaces for food and feeding stuffs, for treatment of food, feeding stuffs
and drinking water, or nearby or directly on livestock that will be used for food manufacturing industry
B.6.1 / Identification of the residues (identity and concentrations), degradation and reaction products and of metabolites of the active substance on livestock that will be used for food manufacturing industry and in contaminated foods or feeding stuffs / 6.15.1
B6.2 / Behaviour of the residues of the active substance, its degradation and reaction products and, where relevant, its metabolites onlivestock that will be used for food manufacturing industry and in contaminated foods or feeding stuffsincluding the kinetics of disappearance / 6.15.2
B6.3 / Data of residue levels that establish when the active substance is below MRL (Maximum Residue Level) in the product
Studies of residue levels can be performed without radioactive labelled substance. These studies must be performed for all animals that are comprised in the application. Residues should be measured in liver, kidney, fat, muscle and also in milk, egg and honey when needed / Guidance on Estimating Livestock Exposure to Active Substances used in Biocidal Products[1]
Risk characterisation and assessment of Maximum Residue Limits (MRL) for biocides[2]
B6.4 / Estimation of potential or actual exposure of the active substance to humans or animals through livestock, animal stables, food and feeding stuffs or other means / 6.15.3

B7. Ecotoxicological properties of the productChapter 3, part B

B7.1 / Acute toxicity to honeybees / 7.8.2
B7.2 / Acute toxicity to fish / 7.7.1.1
B7.3 / Acute toxicity to invertebrates (Daphnia) / 7.7.1.1
B7.4 / Growth inhibition test on
algae / 7.7.1.1
B7.5 / Toxicity to micro-organisms / 7.7.1.1
B7.6 / Acute oral toxicity to birds / 7.6.1
B7.7 / Toxicity to terrestrial vertebrates other than birds / 7.8.1

B8. Physical, chemical and technical properties of the productChapter2, part B

B8.1 / pH / 3.5
B8.2 / Density
Only for liquids / 3.6
B8.3 / Viscosity
Only for liquids / Chapter 3 part A 3.14
B8.4 / Particle size
For powders and granulates / 3.11
B8.5 / Suspension or emulsion stability / 3.8
B8.6 / Storage stability / 3.7
B8.7 / Oxidising properties / 3.3
B8.8 / Volatility
B8.9 / Flash point / 3.4
B8.10 / Explosive properties / 3.2
B8.11 / Other relevant information

B9. Method of destruction

B9.1 / Method of destruction
Propose chemical or other method for the destruction/recycling of the product and packages

B10. Method of analysis of productChapter 2, part B

B10.1 / Method of analysis
State method for qualitative and quantitative analysis of active substances in the product. / 4.1

B11. Recommended risk and protection information related to:

B11.1 / Handling
Enclose draft of safety data sheet for the product and for all included substances
B11.2 / Storage
B11.3 / Transport
B11.4 / Fire

B12. Human toxicity

B12.1 / Medical data
State data and information on the effect of human exposure derived from medical surveillance on manufacturing plant personnel, health records, clinical cases, poisoning incidents or epidemiological data

B13. Measures to take in case of poisoning

B13.1 / Specific treatment in case of an accident or poisoning
State therapeutic regimes and the use of antidotes

B14. Reference list

B14.1 / Reference list
State title, author, laboratory and other facilitating identification of enclosures.
Specify any new studies/reports at application for extension of approval

Table B1

GIFAP-code / Formulation
Swedish version / Formulation type
English version
AB / Sädesbete / Grain bait
AE / Aerosolbehållare / Aerosol dispenser
AL / Andra vätskor att brukas outspädda / Other liquids to be applied undiluted
AP / Övrigt pulver / Other powder
BB / Blockbete / Block baits
BR / Brikett / Briquette
CB / Betekoncentrat / Bait concentrate
CG / Inkapslat granulat / Encapsulated granule
CS / Kapselsuspension / Capsule suspension
DC / Dispergerbart koncentrat / Dispersible concentrate
DP / Puder / Dustable powder
DS / Torrbetningspuder / Powder for dry seed treatment
EC / Emulsionskoncentrat / Emulsifiable concentrate
ED / Vätska för elektrostatisk sprutning / Electrochargeable liquid
EO / Emulsion, vatten i olja / Emulsion, water in oil
ES / Emulsion för betning / Emulsion for seed treatment
EW / Emulsion, olja i vatten / Emulsion, oil in water
FD / Rökdosa / Smoke tin
FG / Fingranulat / Fine granule
FK / Rökljus / Smoke candle
FP / Rökpatron / Smoke cartridge
FR / Rökstav / Smoke rodlet
FS / Suspension för våtbetning / Flowable concentrate for seed treatment
FT / Röktablett / Smoke tablet
FU / Rökgenerator / Smoke generator
FW / Rökpellet / Smoke pellet
GA / Komprimerad gas / Gas
GB / Granulerat bete / Granular bait
GE / Gasutvecklande produkt / Gas generating product
GG / Makrogranulat / Macrogranule
GL / Emulgerbar gel / Emulsifiable gel
GP / Finpuder / Flo-dust
GR / Granulat / Granule
GS / Oljepasta / Grease
GW / Vattenlöslig gel / Water soluble gel
HN / Varmdimningskoncentrat / Hot fogging concentrate
KK / Kombinerad förpackning fast/flytande / Combi-pack solid/liquid
KL / Kombinerad förpackning flytande/flytande / Combi-pack liquid/liquid
KN / Kalldimningskoncentrat / Cold fogging concentrate
KP / Kombinerad förpackning fast/fast / Combi-pack solid/solid
LA / Lack / Lacquer
LS / Lösning för våtbetning / Solution for seed treatment
MG / Mikrogranulat / Microgranule
OF / Oljeblandbar suspension / Oil miscible flowable concentrate
(oil miscible suspension)
OL / Oljeblandbar lösning / Oil miscible liquid
OP / Oljeblandbart pulver / Oil dispersible powder
PA / Pasta på vattenbas / Paste
PB / Plattbete / Plate bait
PC / Gel eller pasta koncentrat / Gel or paste concentrate
PO / Lösning för allmän hudbehandling (tvättning) / Pour-on
PR / Impregnerad stav / Plant rodlet
PS / Dragerat utsäde / Seed coated with a pesticide
RB / Bruksfärdigt bete / Bait (ready for use)
SA / Lösning för lokal hudbehandling / Spot-on
SB / Bete i bitar / Scrap bait
SC / Suspensionskoncentrat / Suspension concentrate (= flowable concentrate)
SE / Suspo-emulsion / Suspo-emulsion
SG / Vattenlösligt granulat / Water soluble granules
SL / Vattenlösligt koncentrat / Soluble concentrate
SO / Filmbildande olja / Spreading oil
SP / Vattenlösligt pulver / Water soluble powder
SS / Vattenlösligt pulver för betning / Water soluble powder for seed treatment
SU / ULV-suspension / Ultra-low volume (ULV) suspension
TB / Tablett / Tablet
TC / Teknisk vara / Technical material
TP / Ströpulver / Tracking powder
UL / ULV-lösning / Ultra-low volume (ULV) liquid
VP / Preparat som avger verksam beståndsdel i gasform / Vapour releasing product
WG / Vattendispergerbart granulat / Water dispersible granules
WP / Slampulver / Wettable powder
WS / Suspension för betning / Water dispersible powder for slurry treatment
XX / Andra / Others

May 20121 (10)

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