Powdered Corn Cob Product-type PT 14 (Rodenticides) · PDF filePowdered Corn Cob Product-type...

Directive 98/8/EC concerning the placing biocidal

products on the market

Inclusion of active substances in Annex I or IA to Directive 98/8/EC

Assessment Reporti

Powdered Corn Cob

Product-type PT 14

(Rodenticides)

September 2012

Annex I / IA – RMS Hellas

Powdered Corn Cob Product-type PT 14 September 2012

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Powdered Corn cob (PT 14)

Assessment report

Finalised in the Standing Committee on Biocidal Products at its meeting in view of its

inclusion in Annex I or IA to Directive 98/8/EC

CONTENTS

1. STATEMENT OF SUBJECT MATTER AND PURPOSE .................................................... 3

1.1. Procedure followed ....................................................................................................... 3

1.2. Purpose of the assessment report .................................................................................. 4

1.3. Overall conclusion in the context of Directive 98/8/EC .............................................. 4

2. OVERALL SUMMARY AND CONCLUSIONS .................................................................. 6

2.1. Presentation of the Active Substance ........................................................................... 6

2.1.1. Identity, Physico-Chemical Properties & Methods of Analysis ................... 6

2.1.2. Intended Uses and Efficacy ........................................................................... 8

2.1.3. Classification and Labelling .......................................................................... 9

2.2. Summary of the Risk Assessment ................................................................................ 9

2.2.1. Human Health Risk Assessment .................................................................... 9

2.2.2. . Environmental Risk Assessment ............................................................... 12

3. DECISION ............................................................................................................................. 15

3.1. Background to the Decision........................................................................................ 15

3.2. Elements to be taken into account by Member States when authorising

products 17

APPENDIX I: LIST OF ENDPOINTS .......................................................................................... 18

Chapter 1: Identity, Physical and Chemical Properties, Classification

and Labelling ............................................................................ 18

Chapter 2: Methods of Analysis .................................................................. 20

Chapter 3: Impact on Human Health ........................................................... 21

Chapter 4: Fate and Behaviour in the Environment .................................... 22

Chapter 5: Effects on Non-target Species .................................................... 24

Chapter 6: Other End Points ........................................................................ 25

APPENDIX II: LIST OF INTENDED USES ................................................................................ 26

TABLE: LIST OF INTENDED USES SUPPORTED BY THE SUBMITTED DATA ............... 26

APPENDIX III: LIST OF STUDIES ............................................................................................. 27


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1. STATEMENT OF SUBJECT MATTER AND PURPOSE

1.1. Procedure followed

This assessment report has been established as a result of the evaluation of corn cob as

product-type PT 14 ([Rodenticides]), carried out in the context of the work programme for

the review of existing active substances provided for in Article 16(2) of Directive 98/8/EC

concerning the placing of biocidal products on the market1, with a view to the possible

inclusion of this substance into Annex I or IA to the Directive.

Powdered corn cob (CAS no. [none]) was initially notified as an existing active substance,

by Natrocell Technologies Limited in product-type PT14. Ιn 2009, Zea Sciences Limited,

hereafter referred to as the applicant, confirmed to the European Commission, ownership

of the dossier.

Commission Regulation (EC) No 2032/2003 of 4 November 20032 lays down the detailed

rules for the evaluation of dossiers and for the decision-making process in order to include

or not an existing active substance into Annex I or IA to the Directive.

In accordance with the provisions of Article 5(2) of that Regulation, Greece was designated

as Rapporteur Member State to carry out the assessment on the basis of the dossier

submitted by the applicant. The deadline for submission of a complete dossier for

Powdered corn cob as an active substance in Product Type PT14 was 28/3/2004, in

accordance with Annex V of Regulation (EC) No 2032/2003.

On 28/3/2004, RMS competent authorities received a dossier from the applicant. The

Rapporteur Member State accepted the dossier as complete for the purpose of the

evaluation on 6/12/2004.

On 22/10/2009, the Rapporteur Member State submitted, in accordance with the provisions

of Article 10(5) and (7) of Regulation (EC) No 2032/2003, to the Commission and the

applicant a copy of the evaluation report, hereafter referred to as the competent authority

report. The Commission made the report available to all Member States by electronic

means on 21 September 2012. The competent authority report included a recommendation

for the inclusion of Powdered corn cob in Annex I and I / IA to the Directive for PT 14.

In accordance with Article 12 of Regulation (EC) No 2032/2003, the Commission made

the competent authority report publicly available by electronic means on 21 September

2012. This report did not include such information that was to be treated as confidential in

accordance with Article 19 of Directive 98/8/EC.

In order to review the competent authority report and the comments received on it,

consultations of technical experts from all Member States (peer review) were organised by

1 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the

placing biocidal products on the market. OJ L 123, 24.4.98, p.1

2 Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work

programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the

Council concerning the placing of biocidal products on the market and amending Regulation (EC) No

1896/2000. OJ L 307, 24.11.2003, p. 1


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the Commission. Revisions agreed upon were presented at technical and competent

authority meetings and the competent authority report was amended accordingly.

On the basis of the final competent authority report, the Commission proposed the

inclusion of Powdered corn cob in Annex I / IA to Directive 98/8/EC and consulted the

Standing Committee on Biocidal Product on

In accordance with Article 11(4) of Regulation (EC) No 2032/2003, the present assessment

report contains the conclusions of the Standing Committee on Biocidal Products, as

finalised during its meeting held on.

1.2. Purpose of the assessment report

This assessment report has been developed and finalised in support of the decision to

include Powdered corn cob in Annex I and I / IA to Directive 98/8/EC for product-type

PT14. The aim of the assessment report is to facilitate the authorisation [/registration] in

Member States of individual biocidal products in product-type PT14 that contain powdered

corn cob In their evaluation, Member States shall apply the provisions of Directive

98/8/EC, in particular the provisions of Article 5 as well as the common principles laid

down in Annex VI.

For the implementation of the common principles of Annex VI, the content and

conclusions of this assessment report, which is available at the Commission website3, shall

be taken into account.

However, where conclusions of this assessment report are based on data protected under

the provisions of Directive 98/8/EC, such conclusions may not be used to the benefit of

another applicant, unless access to these data has been granted.

1.3. Overall conclusion in the context of Directive 98/8/EC

The overall conclusion from the evaluation is that it may be expected that there are

products containing powdered corn cob for the product-type PT14, which will fulfil the

requirements laid down in Article 10(1) and (2) of Directive 98/8/EC. This conclusion is

however subject to:

i. compliance with the particular requirements in the following sections of this

assessment report,

ii. the implementation of the provisions of Article 5(1) of Directive 98/8/EC, and

iii. the common principles laid down in Annex VI to Directive 98/8/EC.

Furthermore, these conclusions were reached within the framework of the uses that were

proposed and supported by the applicant (see Appendix II). Extension of the use pattern

beyond those described will require an evaluation at product authorisation level in order to

3 http://ec.europa.eu/comm/environment/biocides/index.htm

http://ec.europa.eu/comm/environment/biocides/index.htm


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establish whether the proposed extensions of use will satisfy the requirements of Article

5(1) and of the common principles laid down in Annex VI to Directive 98/8/EC.


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2. OVERALL SUMMARY AND CONCLUSIONS

2.1. Presentation of the Active Substance

2.1.1. Identity, Physico-Chemical Properties & Methods of Analysis

2.1.1.1 Name, address of applicant of active substance

Applicant:

Name: Zea Sciences Limited

Address: The Barn Audley End Business Centre, Wendens Ambo, Saffron Walden, Essex

CB11 4JL UK

Telephone: +44 (0) 1673 885138

Fax number: +44 (0) 1673 885163

E-mail address: [email protected]

2.1.1.2 Identity of the active substance

Common name, synonym: Powdered Corn cob.

CAS-No.: None

EINECS-No.: None

CIPAC: None

IUPAC Name: None

CA Name: None

mailto:[email protected]


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Purity: 100% (Due to the nature of the active substance as

Powdered Corn Cob we can consider the central core of a

maize).

Molecular weight (g/mol): Powdered corn cob is a naturally occurring composite

material and thus does not have specific molecular

weight.

Molecular formula: Powdered corn cob is a naturally occurring composite

material and thus does not have a specific molecular

formula.

Structural formula: Powdered corn cob is a naturally occurring composite

material and thus does not have a specific structural

formula

2.1.1.3 Physico-chemical properties of the active substance

Stripped corn cobs are ground into powder to produce the active substance corn cob. It is a

solid tan coloured powder with negligible odour. A melting point of 1204-1325°C has been

reported for 100% natural corn cob fractions. Powdered Corn cobs do not have a boiling point.

Powdered Corn cob is a carbohydrate material, poorly soluble in water and all solvents.

Powdered Corn cobs are very stable and are non-flammable at normal temperatures. If ignited,

combustion products may include components typical of wood smoke.

2.1.1.4 Methods of analysis

Analysis of the active substance as manufactured

An analytical method is not identifiable.

Formulation analysis

An analytical method is not identifiable.


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Residue analysis

Powdered corn cobs decompose mainly to sugars which are readily incorporated into

intermediary metabolism in the environment. Thus there are no residues which pose a threat to

human or animal health or the environment.

2.1.2. Intended Uses and Efficacy

Powdered corn cob is the main ingredient in Eradirat and Eradimouse, which are used as

rodenticides for the eradication of unwanted rats (Rattus norvegicus) and mice (Mus musculus),

respectively.

Based on the available data, Eradirat and Eradimouse, when consumed by rats and mice,

rapidly cause a state of dehydration. This leads to significant perturbation of normal

physiological feedback pathways because dehydration is accompanied not by an increase in

water intake but rather by a reduction in it. Several mechanisms are postulated for the

proximate cause of the dehydration, the most likely of which is passage of fluid across the

intestinal epithelium caused by the extremely absorptive nature of Powdered Corn Cob bait.

Based on combined experimental measurements and clinical observations, it appears that the

consumption of the active substance Powdered Corn Cob causes acute dehydration, with

consequent hypovolemia (i.e. reduced blood volume), reduced blood pressure, tissue ischemia

(oxygen deprivation), and circulatory shock leading to death.As it is stated in the Manual of

Decisions (See 2.3.11. Cellulose product as a rodenticide), “this mode of action is covered by

the Biocidal Products Directive, and these active substances have to be notified and evaluated.

For these particular products, the possibilities for justifying waiving of data as provided for in

Article 8(5) of the Directive should also be examined”.

As far as the Humaneness of powdered corn cob products is concerned, it is reported that

animals feeding on Powdered Corn Cob baits remain apparently normal for several days until

they become ‘huddled and lethargic’ in the last few hours before dying. The main external

symptoms observed were lethargy, piloerection and, occasionally, tremors. None of the

symptoms appeared to be noticeably severe, although this is not necessarily indicative of an

humane end-point.

As far as the efficacy is concerned, the Applicant has provided 18 efficacy studies, comprised

of 10 field trials and 8 laboratory studies. Of the field trials, 8 have been conducted against

small populations of rodents, however one was conducted against populations of 12 rats and 40

mice, and the last was against an estimated population of 60-70 rats. In all of these studies,

there was no take of the census bait after treatment, indicating 100 % control of the rodent

population (efficacy in a rodenticide field study is assessed by comparing how much of a

census bait is eaten before and after treatment - the less that is eaten after treatment, the better

the control)

The Applicant has also provided 8 no-choice laboratory studies, 6 against rats and 2 against

mice, where the test animals were provided with excess bait as their only food source. In all 8

studies 100 % mortality was recorded at the end of the test.


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While there are issues with this data package (such as the low target numbers in the field

studies, and because there are only no-choice tests available in the laboratory studies), the

overall data package still demonstrates that the active substance is capable of having an effect

on the target organisms.

While the data package is definitely not suitable to support a product authorisation (as further

data, including laboratory palatability and confirmatory field data against larger rodent

populations will be required), the current data package is suitable to demonstrate the innate

activity of the active substance, as required to recommend inclusion of the active substance

onto Annex I for this Product Type in terms of efficacy.

In addition, in order to facilitate the work of Member States in granting or reviewing

authorisations, and to apply adequately the provisions of Article 5(1) of Directive 98/8/EC and

the common principles laid down in Annex VI of that Directive, the intended uses of the

substance, as identified during the evaluation process, are listed in Appendix II.

2.1.3. Classification and Labelling

Classification and labelling of the active substance

Based on the available data, no classification is currently used or proposed for powdered corn

cob concerning its physico-chemical, toxicological, environmental and ecotoxicological

properties in accordance with Annex I of Council Directive 67/548/EEC and the CLP

Regulation 1272/2008.

Classification of the products

No classification is proposed for the products EradiRat and EradiMouse concerning their

physico-chemical, toxicological, environmental and ecotoxicological properties in accordance

with Directive 1999/45/EC and the CLP Regulation 1272/2008.

2.2. Summary of the Risk Assessment

2.2.1. Human Health Risk Assessment

2.2.1.1. Hazard identification

Several published reports have been submitted concerning mammalian toxicology of the

active substance. Most of them concern Cellulon fibres (a cellulose produced by bacterial

fermentation process) or microcrystalline cellulose. There are, also, feeding studies using

powdered corn cob as part of the diet of different species (e.g. rats, pigs, sheeps, cockerels,

lamps, cows etc.). Additionally, an evaluation report of the Joint FAO/WHO Expert

Committee on Food Additives has been submitted concerning cellulose.

Cellulose is the predominant substance in powdered corn cob, contained at levels of 40-

45%. The applicant has argued that cellulose is commonly used in many products intended


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for human and animal consumption and has been more widely studied than powdered corn

cob. Besides, cellulose has been characterized as G.R.A.S. (generally recognized as safe) by

the US FDA. The cellulose studies have been accepted by the Competent Authority, only as

indicative of the toxicity of corn cob. The subchronic studies in rats indicate that at level of

about 50% cellulose in the diet (about the same percentage as in powdered corn cob),

It is noted that the results of the submitted studies indicate that powdered corn cob do not

cause adverse effects when administered in a variety of animals including rats. On the

contrary, powdered corn cob administration may even be beneficial to the animals, even the

rodents. This fact seems not in accordance with the rodenticidal action of corn cob but it is

easily to be explained since the doses administered in the toxicity studies are much lower

that the amount of corn cob consumed in the efficacy studies. Based on the efficacy data,

the lethal dose is estimated to be 200-300 g/kg b.w., whereas based on the results of the

acute toxicity study of the product Eradirat (94% corn cob w/w) the LD50 is estimated to be

>15.1 g/kg b.w.

2.2.1.2. Effects assessment

No conventional metabolism study was submitted. The waiving was accepted as

powdered corn cob is a natural product of low toxicity. Nine published reports investigating

the effects of powdered corn cob when fed to either rats, cockerels, ruffed grouse, chukar

partridge, bobwhite quail, sheep, lambs, pigs and ruminants have been submitted by the

applicant in order to address the ADME data. The submitted studies are considered

indicative of both the safe use of powdered corn cob as a feeding stuff and the low

digestibility of corn cob when fed to mammals.

As far as the acute oral toxicity of powdered corn cob is concerned, apart from the

FAO/WHO Report on microcrystalline cellulose, two published reports describing studies

conducted with either Cellulon fibres (a cellulose produced by bacterial fermentation

process) or microcrystalline cellulose have been submitted. Both substances were of low

acute toxicity when administered to rats or rabbits.

The skin and eye irritation of powdered corn cob was addressed by the submission of skin

and eye irritation studies conducted with Cellulon fiber, a cellulose produced by a bacterial

fermentation process and which most closely resembles powdered and microcrystalline

cellulose. The material tested caused no irritation effect when applied to rabbits.

Skin sensitization data were included in the Joint FAO/WHO Expert Committee on Food

Additives (1998) review of microcrystalline cellulose. The material tested exhibited no

sesnsitization potential.

The subchronic toxicity data included apart from the FAO/WHO Report on

microcrystalline cellulose, two published reports conducted with powdered corn cob: a 4-

week feeding study in hens and a 40-day feeding study in cattle. Besides, a subchronic

toxicity study conducted with Cellulon fibres was submitted from which it can be concluded

that administration of Cellulon fibre at dosages of 5 and 10% in the diet of rats for 13 weeks

did not induce any toxic effects.

The submitted studies are considered indicative of both the safe use of powdered corn

cob as a feeding stuff and the very low toxicity of powdered corn cob when fed to mammals.


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Based on the submitted short term toxicity data on powdered corn cob it is not possible to

establish a NOAEL/NOEL value, due to the absence of any toxic effects. Nevertheless, since

the test substance is a natural product of low toxicity the RMS considers that this is not a

significant deviation concerning the inclusion of the substance in the Annex I of Dir.

98/8/EC.

Apart from the genotoxicity data FAO/WHO Report on microcrystalline cellulose,

several published reports concerning in vitro tests conducted with either Cellulon fibres (a

cellulose produced by bacterial fermentation process), microcrystalline cellulose or powdered

corn cob have been submitted (Table 4.6). According to the results of these reports, the

tested substances demonstrate no genotoxic potential.

Carcinogenicity data were included in the Joint FAO/WHO Expert Committee on Food

Additives (1998) review of microcrystalline cellulose. The material tested exhibited no

carcinogenic potential.

The submitted reproductive toxicity data included the FAO/WHO Report on

microcrystalline cellulose and several published reports with dietary administration of

powdered corn cob in many species (female sheep, pigs, cows). Among the parameters

examined were weight at puberty and at first oestrus cycle, interval of puberty to first normal

oestrus cycle, weaning-to-oestrus intervals and individual and total litter birth weight. No

significant effect was noted on any of the reproductive parameters examined. These studies

are considered indicative of both the safe use of powdered corn cob as a feeding stuff and

the very low reproductive toxicity of powdered corn cob when fed to mammals.

Based on the submitted data on powdered corn cob it is not possible to establish a

reproductive NOAEL/NOEL value, due to the absence of any toxic effect. Nevertheless,

since the test substance is a natural product of low toxicity the RMS considers that this is not

a significant deviation concerning the inclusion of the substance in the Annex I of Dir.

98/8/EC.

In addition, in the FAO/WHO Report on microcrystalline cellulose, results of two

volunteer studies were reported. In both studies, no adverse effect to human was observed

after microcrystalline cellulose administration.

2.2.1.3. Exposure assessment

Test sites could be either inside buildings or outside depending on the location of the

rat or mouse infestation. Loose pellets of Eradirat or Eradimouse should be placed in bait

stations within the infested areas. The finished product is made of food-grade ingredients

and is totally safe to handle for both professional users and the general public. Special

protective equipment is not required, but users are advised to wear gloves when dispensing

material to protect them from rodent-borne diseases within the infested area. Therefore the

dermal exposure will be negligible. As the biocidal product is provided as a pelleted dust

free product, there will be no inhalation exposure to the active substance in the finished

product when handling it. Secondary exposure is possible in case of accidental ingestion of

the pelleted product. According to the reverse reference scenario and if the minimum

efficacious amount of 200 g/kg bw/d is considered, a 10 kg infant would have to ingest 2 kg

of product, equivalent to the contents of >13 bait stations loaded at 150 g/station according

to the ‘Eradirat’ product label. It is also noted that the HUMAN EXPOSURE TO

BIOCIDAL PRODUCT (TNsG, June 2007) indicates that it should be assumed that an


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infant ingests a maximum of 5 g of bait, which is 400 times less than the 2 kg total dose

considered in the reverse reference scenario.

2.2.1.4. Risk characterisation

Based on the submitted data on powdered corn cob, it is not possible to establish a

NOAEL/NOEL value, due to the absence of any toxic effect. The submitted studies of

cellulose have been accepted by the Competent Authority, only as indicative of the toxicity

of corn cob.

Based on the submitted data on cellulose, the subchronic studies in rats indicate that at

level of about 50% cellulose in the diet (about the same percentage as in powdered corn cob)

there are no toxicological effects. Therefore, it seems that the concentration of powdered

corn cob and its composition as a whole natural product is the source of the rodenticidal

effect. Since the rodenticidal action of powdered corn cob cannot be attributed solely to

cellulose, the cellulose studies cannot be used for the establishment of an Acceptable

Exposure Level (AEL).

Conclusively, the setting of and AEL is not possible. This fact is not considered a

significant deviation for the inclusion of the substance in the Annex I of BPD, since

powdered corn cob is a natural product of low toxicity. The same policy of the non

establishment of Reference Values has been followed also for many natural products of low

toxicity (e.g. sheep fat, hydrolyzed proteins, paraffin oils, fish oil, tall oils, etc) evaluated in

the frames of the Plant Protection Products Directive 91/414/EEC.

2.2.2. . Environmental Risk Assessment

2.2.2.1 Fate and distribution in the environment

Powdered corn cobs are composed of plant carbohydrate material, and are poorly soluble

in water and other solvents. They are very stable and do not become partitioned between

aqueous phases and organic surfaces of soils, sediments and sludge.

The most labile parameter of the quality of powdered corn cobs during storage is the

monosaccharide content. Monosaccharides start to break down much earlier than the

appearance of putrefaction. The appearance of moulds and change in the colour of the cobs is

seen once the process of putrefaction is already considerably underway. Powdered corn cobs

stored outdoors rapidly deteriorate, whereas there are no significant changes in the quality of

cobs stored indoors for up to 5 months.

2.2.2.2. Effects assessment

Eradirat and Eradimouse are intended to be used by professional pest control officers and

the general public to eradicate unwanted rats and mice. Eradirat and Eradimouse can be used

both inside buildings and outdoors. When used outside, it is recommended that the product is

protected from moisture and where possible placed in the nesting burrows of the rats and mice

or in their feeding stations. A total of up to 150g of product should be used per rat baiting

point (plus loss and spillage) and around 50g of product per mouse baiting point. Feeding


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stations should be replenished daily. It is estimated that rodents die from consuming more than

200-300g/kg bodyweight over a period of several days.










Cellulose was shown to have no hazardous effects on environmental organisms, indeed it,

and its breakdown products, can provide an important food source for various organisms.

Likewise, powdered corn cob is a natural plant material which decomposes mainly to sugars,

which are readily incorporated into intermediary metabolism in the environment and thus

present no hazard to environmental organisms.

2.2.2.2.1 Aquatic environment (fresh water & sediment)

See above.

2.2.2.2.2 Atmosphere

No data were submitted by the applicant. However, as powdered corn cob is a natural

plant material which decomposes to products which are readily incorporated into

metabolism, this route of exposure is not considered to pose any risks.

2.2.2.2.3 Terrestrial compartment

See above.

2.2.2.3. PBT assessment

Powdered corn cob cannot be regarded as fulfilling the PBT-criteria. Powdered corn cobs

are composed of plant material. They do not act as a chemical and become partitioned between

aqueous phases and organic surfaces of soils, sediments and sludge. If left outside cobs

decompose mainly to sugars which are readily incorporated into intermediary metabolism in

the environment. The most labile parameter of the quality of powdered com cobs during storage

is the monosaccharide content. Monosaccharides start to break down much earlier than the







Likewise, powdered com cob is a natural plant material which decomposes mainly to sugars,



The fate in water of dead plant material (containing cellulose) imported from the

surrounding drainage basin, where it is attacked by fungi and bacteria (some aquatic and some


14

which were originally present in the plant material) it will be decomposed, mainly to sugars

which are readily incorporated into intermediary metabolism in the environment. Where

various essential nutritional elements such as nitrogen, phosphorus, calcium, magnesium and

potassium are in a high enough concentration not to limit growth, the fungi flourish, increasing

the amount of protein in the detritus, which provides a suitable food source for invertebrates

and, in turn, predatory fish. The ability of cellulose in the aquatic environment to degrade is

indicative of a low risk to aquatic systems as it effects more as a feed rather than a toxicant. It

does not biaccumulate as it is one of the waste by-products of corn, a food crop grown world-

wide for both human and animal. The other ingredients in Eradirat and Eradimouse are

molasses and wheat flour (Eradirat only). They are both food stuffs and are also classified by

the US EPA as Minimal Risk Inerts.

2.2.2.4. Exposure assessment

Eradirat and Eradimouse are intended to be used by professional pest control officers and

the general public to eradicate unwanted rats and mice. Eradirat and Eradimouse can be used

both inside buildings and outdoors. When used outside, it is recommended that the product is

protected from moisture and where possible placed in the nesting burrows of the rats and mice

or in their feeding stations. A total of up to 150g of product should be used per rat baiting point

(plus loss and spillage) and around 50g of product per mouse baiting point. Feeding stations

should be replenished daily. It is estimated that rodents die from consuming more than 200-

300g/kg bodyweight over a period of several days.















Aquatic environment (fresh water & sediment)

See above.

Air

No data were submitted by the applicant. However, as powdered corn cob is a natural

plant material which decomposes to products which are readily incorporated into

metabolism, this route of exposure is not considered to pose any risks.

Terrestrial compartment


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See above.

2.2.2.5. Risk characterisation

Corn-on-the-cob is a food crop grown world-wide for both human and animal

consumption. One of the waste by-products, the stripped powdered corn cobs, is used for a

variety of purposes including animal bedding, fuel and animal feed. Powdered corn cobs

decompose mainly to sugars which are readily incorporated into intermediary metabolism in

the environment. Thus the active substance, powdered corn cob, clearly does not pose any

threat to the environment. In addition, the other ingredients are also human food substances

derived from plant products; molasses and wheat flour. They too do not pose any risk or hazard

to the environment.















Tests on terrestrial animals(included in the dossiers)such as dogs, cats, rabbits, ducks and

chickens all indicated that when ingested, no adverse effects are observed. The material is not

palatable to non-rodents.

Non-rodent species have consistently been found to not consume the same quantities of

the product as compared to commensal rodents on a g/Kg body weight basis. Indeed the

product is generally not palatable to non-rodents. The extensive non-target species testing,

extensive rodent control field trials as well as the inherent safety of the cellulose active

ingredient is justification for not specifically conducting field trials aimed at non species

effects. Field trials to date have not indicated any adverse effect on non-rodent species. In

addition, powdered corn cob products have been used extensively in industry for many years

without reported impact on animals(Physical properties. Chemical properties and the uses of

the Andersons' corn cob products, 2 nd edition, 1978, pages 215). Further tests on non-rodent

animals in field trials are unjustified from an efficacy as well as a humaneness perspective (see

efficacy and toxicology section).

3. DECISION

3.1. Background to the Decision


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The overall conclusion from the evaluation of powdered corn cob for use as a rodenticide

(PT14) for professional and non-professional users is that the substance fulfils the safety

requirements laid down in Article 10(1) of Directive 98/8/EC. It is expected that it will be

possible for MS to issue authorisations for products containing powdered corn cob in

accordance with the conditions laid down in article 5 (1) (b-d) of Directive 98/8/EC. Powdered

corn cob is therefore proposed for inclusion into Annex I and IA of that Directive.

The efficacy of powdered corn cob as a rodenticide against rat (Rattus norvegicus) and mouse

(Mus musculus) has been sufficiently demonstrated and the formulated products satisfy efficacy

evaluation requirements for Annex I listing of the active substance. As stated by the applicant,

further efficacy studies will be required, and will be presented at the stage of Product

Authorisation.

Powdered corn cob as a natural by-product of corn is of low toxicity to human health, based on

the results conducted either with corn cob or with cellulose which is the predominant ingredient

of corn cob (40-45%). Primary human exposure of corn cob is negligible since the products are

dust free pellets and no dermal exposure will occur since the use of gloves is recommended.

Secondary exposure may occur in case of accidental ingestion of the pellets but will cause no

adverse effects, since an infant should ingest an amount 2kg of bait which is 400 times higher

than the standard amount of 5gr bait assumed by the TNsG for human Exposure (June 2007) to

experience adverse effects. In any case it is recommended to keep the products away from

children.

The active substance is powdered corn cob. The data provided shows that neither the biocidal

products nor the active substance pose any risk to the environment.

Loose pellets of Eradirat or Eradimouse are placed in bait stations (or directly into burrows)

within the infested areas which can be either inside buildings or outside. Powdered corn cobs,

are poorly soluble (<10%) and naturally decompose mainly to sugars which are readily

incorporated into intermediary metabolism in the environment.

The Biocides Directive defines a low-risk biocidal product as: “A biocidal product which

contains as active substance(s) only one or more of those listed in Annex IA and which does

not contain any substance(s) of concern. Under the conditions of use, the biocidal product shall

pose only a low risk to humans, animals and the environment” (Article 2 (1) b)). Eradirat and

Eradimouse (active substance powdered corn cob) do not contain any substances of concern.

Furthermore, under the conditions of use, the biocidal active substance corn cob pose no risk to

humans, animals and the environment and thus should be included in Annex IA.

Powdered corn cobs, the by-product of the food crop corn-on-the-cob, have been used for many

years in a variety of products including animal feed and bedding, and fuel. The other

ingredients, molasses and wheat flour (Eradirat only), are human foodstuffs and thus are also

not hazardous materials.

3.2. Decision regarding Inclusion in Annex I


17

On the basis of the proposed and supported use, it is concluded that the proposed use of powdered

corn cob as a rodenticide fulfils the safety requirements laid down in Article 5(1) of Directive

98/8/EC. It is therefore proposed that powdered corn cob to be included into Annex I and IA of the

Directive 98/8/EC as an active substance in rodenticide products (product type 14), with the

following provisions :

* In Annex I :

When assessing the application for authorisation of a product in accordance with Article 5 and

Annex VI, Member States shall assess, where relevant for the particular product, those uses or

exposure scenarios and those risks to human populations and to environmental compartments

that have not been representatively addressed in the Union level risk assessment.’

* In Annex IA :

Member States shall ensure that registrations are subject to the following condition: — Only

for use in the form of pellets in dry locations.

3.3. Elements to be taken into account by Member States when authorising products

Further efficacy studies regarding the biocidal products containing corn cob powdered should

be submitted.


18

Appendix I: List of endpoints

Chapter 1: Identity, Physical and Chemical Properties, Classification and

Labelling

Active substance (ISO Common Name) Powdered Corn cob,

Product-type 14

Identity

Chemical name (IUPAC) None

Chemical name (CA) None

CAS No None

EC No None

Other substance No. None

Minimum purity of the active substance as

manufactured (g/kg or g/l)

1000g/kg (Due to the nature of the active substance as

Corn Cob we can consider the core of a maize.)

Identity of relevant impurities and additives

(substances of concern) in the active substance as

manufactured (g/kg)

No substances of concern

Molecular formula Powdered corn cob is a naturally occurring composite

material and thus does not have a molecular formula

Molecular mass Powdered corn cob is a naturally occurring composite

material and thus does not have molecular mass.

Structural formula

Powdered corn cob is a naturally occurring composite

material and thus does not have a structural formula.


19

Physical and chemical properties

Melting point (state purity) 100% natural corn cob fractions have a melting point of

1204-1325°C.

Boiling point (state purity) n.a.

Temperature of decomposition Due to the nature of the active substance it is expected to

be stable

Appearance (state purity) Solid tan powder

Relative density (state purity) 0.288 – 0.416g/cm3 (woody portion of the corn cob)

(Bulk density)

Surface tension n.a.

Vapour pressure (in Pa, state temperature) n.a.

Henry’s law constant (Pa m3 mol

-1) n.a.

Solubility in water (g/l or mg/l, state temperature) Due to the nature of the active substance it is expected to

have poor solubility in water

Solubility in organic solvents (in g/l or mg/l, state

temperature)

Due to the nature of the active substance it is expected to

have poor solubility in all solvents.

Stability in organic solvents used in biocidal

products including relevant breakdown products

Due to the nature of the active substance it is expected to

have poor solubility in all solvents

Partition coefficient (log POW) (state temperature) n.a.

Hydrolytic stability (DT50) (state pH and

temperature)

n.a.

Dissociation constant n.a.

UV/VIS absorption (max.) (if absorption > 290 nm

state at wavelength)

n.a.

Photostability (DT50) (aqueous, sunlight, state pH) n.a.

Quantum yield of direct phototransformation in

water at > 290 nm

n.a.

Flammability Non highly flammable.

Explosive properties No explosive properties based on the structure of the

compound and the percentage oxygen balance.


20

Classification and proposed labelling

with regard to physical/chemical data None

with regard to toxicological data None

with regard to fate and behaviour data None

with regard to ecotoxicological data None

Chapter 2: Methods of Analysis

Analytical methods for the active substance

Technical active substance (principle of method) An analytical method for identification is not identifiable.

Impurities in technical active substance (principle

of method)

-

Analytical methods for residues

Soil (principle of method and LOQ) Corn cobs decompose mainly to sugars which are readily

incorporated into intermediary metabolism in the

environment. Thus there are no residues which pose a

treat to human or animal health or the environment. .

Furthermore an analytical method is not identifiable.

Air (principle of method and LOQ)

Water (principle of method and LOQ)

Body fluids and tissues (principle of method and

LOQ)

Food/feed of plant origin (principle of method and

LOQ for methods for monitoring purposes)

Food/feed of animal origin (principle of method and

LOQ for methods for monitoring purposes)


21

Chapter 3: Impact on Human Health

Absorption, distribution, metabolism and excretion in mammals

Rate and extent of oral absorption: No data, not required

Rate and extent of dermal absorption: No data, not required

Distribution: No data, not required

Potential for accumulation: No data, not required

Rate and extent of excretion: No data, not required

Toxicologically significant metabolite(s) None

Acute toxicity

Rat LD50 oral >15g/kg b.w.

Rat LD50 dermal No data, not required

Rat LC50 inhalation No data, not required

Skin irritation Not irritating

Eye irritation Not irritating

Skin sensitization (test method used and result) Not sensitising

Repeated dose toxicity

Species/ target / critical effect None

Lowest relevant oral NOAEL / LOAEL Not established, not required

Lowest relevant dermal NOAEL / LOAEL No data, not required

Lowest relevant inhalation NOAEL / LOAEL No data, not required

Genotoxicity No genotoxic potential

Carcinogenicity

Species/type of tumour No carcinogenic potential

lowest dose with tumours Not relevant

Reproductive toxicity

Species/ Reproduction target / critical effect None

Lowest relevant reproductive NOAEL / LOAEL Not established, not required

Species/Developmental target / critical effect None

Developmental toxicity

Lowest relevant developmental NOAEL / LOAEL Not established, not required

Neurotoxicity / Delayed neurotoxicity


22

Species/ target/critical effect No data, not required

Lowest relevant developmental NOAEL / LOAEL. No data, not required

Other toxicological studies

............................................................................... No data, not required

Medical data

............................................................................... No data, not required

Reference values Value Study Assessment

factor

Non-professional user

ADI (acceptable daily intake, external long-term

reference dose) - - -

DWL (Drinking water limit - - -

AELs (Acceptable Exposure Limits. Internal

reference dose):

- - -

AEL short term - - -

AEL medium-term - - -

AEL long-term - - -

ARfD (acute reference dose) - - -

Reference value for inhalation (proposed OEL) - - -

Reference value for dermal absorption - - -

Acceptable exposure scenarios (including method of calculation)

Production of active substance: Not under the scope of the BPD

Professional and non professional users No unacceptable exposure is foreseen

Chapter 4: Fate and Behaviour in the Environment

Corn cobs decompose mainly to sugars which are readily incorporated into intermediary metabolism in the

environment. No further data were submitted by the applicant and thus no arithmetic end-points could be derived.

Route and rate of degradation in water

Hydrolysis of active substance and relevant

metabolites (DT50) (state pH and temperature)

pH______: No data available



Photolytic / photo-oxidative degradation of active

substance and resulting relevant metabolites

No data available


23

Readily biodegradable (yes/no) No data available

Biodegradation in seawater No data available

Non-extractable residues No data available

Distribution in water / sediment systems (active

substance)

No data available

Distribution in water / sediment systems

(metabolites)

No data available

Route and rate of degradation in soil

Mineralization (aerobic)

Laboratory studies (range or median, with number

of measurements, with regression coefficient) DT50lab (20C, aerobic): No data available

DT90lab (20C, aerobic): No data available

DT50lab (10C, aerobic): No data available

DT50lab (20C, anaerobic): No data available

degradation in the saturated zone: No data available

Field studies (state location, range or median with

number of measurements)

DT50f: No data available

DT90f: No data available

Anaerobic degradation No data available

Soil photolysis No data available

Non-extractable residues No data available

Relevant metabolites - name and/or code, % of

applied a.i. (range and maximum)

No data available

Soil accumulation and plateau concentration No data available

Adsorption/desorption

Ka , Kd

Kaoc , Kdoc

pH dependence (yes / no) (if yes type of

dependence)

No data available

Fate and behaviour in air

Direct photolysis in air No data available

Quantum yield of direct photolysis No data available

Photo-oxidative degradation in air Latitude: . No data available Season:

................. DT50 ..............

Volatilization No data available

Monitoring data, if available


24

Soil (indicate location and type of study) No data available

Surface water (indicate location and type of study) No data available

Ground water (indicate location and type of study) No data available

Air (indicate location and type of study) No data available

Chapter 5: Effects on Non-target Species

Toxicity data for aquatic species (most sensitive species of each group)

Species Time-scale Endpoint Toxicity

Fish

No data available

Invertebrates

No data available

Algae

No data available

Microorganisms

No data available

Effects on earthworms or other soil non-target organisms

Acute toxicity to …………………………………..

Not applicable

Reproductive toxicity to …………………………

Not applicable


25

Effects on soil micro-organisms

Nitrogen mineralization Not applicable

Carbon mineralization Not applicable

Effects on terrestrial vertebrates

Acute toxicity to mammals No data available

Acute toxicity to birds

No data available

Dietary toxicity to birds

No data available

Reproductive toxicity to birds

No data available

Effects on honeybees

Acute oral toxicity Not applicable

Acute contact toxicity Not applicable

Effects on other beneficial arthropods

Acute oral toxicity Not applicable

Acute contact toxicity Not applicable

Acute toxicity to …………………………………..

Not applicable

Bioconcentration

Bioconcentration factor (BCF) No data available

Depration time (DT50)

(DT90)

No data available

Level of metabolites (%) in organisms accounting

for > 10 % of residues

No data available

Chapter 6: Other End Points


26

Appendix II: List of Intended Uses

Table: List of Intended Uses supported by the submitted data

MG/PT Field of use envisaged Likely concentration at which

active substance will be used

MG03/Product type

14: Rodenticides for

rats and mice.

Eradirat and Eradimouse are intended for use by

professional pest control officers and the general

public to eradicate unwanted rats (Rattus

norvegicus) and mice (Mus musculus). Eradirat and

Eradimouse can be used both inside buildings and

outdoors. When used outside it is recommended that

the product is protected from moisture, and where

possible, placed down the nesting burrows of the rats

and mice or in their feeding stations.

Eradirat and Eradimouse were first marketed in the

EU (in the UK) in 2000. In 2000 approximately 40

tonnes of the product were imported into the EU, in

2001 approximately 64 tonnes were imported and in

both 2002 and 2003 approximately 120 tonnes of

product were imported. The products can now be

sold in the UK, Norway, Ireland, Italy and Germany.

A total of up to 150g of product

should be used per rat baiting point

(plus loss and spillage) and around

50g of product per mouse baiting

point. Feeding stations should be

replenished daily. It is estimated

that rodents die from consuming

more than 200-300g/kg bodyweight

over a period of several days.


27

Appendix III: List of studies

Data protection is claimed by the applicant in accordance with Article 12.1(c) (i) and (ii) of Council

Directive 98/8/EC for all study reports marked “Y” in the “Data Protection Claimed” column of the

table below. These claims are based on information from the applicant. It is assumed that the

relevant studies are not already protected in any other Member State of the European Union under

existing national rules relating to biocidal products. It was however not possible to confirm the

accuracy of this information.

Section

No/

Reference

No

Author (s) Year Title

Source (where different from

company)

Company, Report No

GLP (where relevant)/(Un)

Published

Data

protection

Claimed

Yes/No

Owner

A3/5

A3/12

A3/15

Andersons, The Cob

Division Processing

Group, Ohio, USA

(editor Foley, K)

1978 Physical properties, Chemical

properties and uses of The

Andersons’ corn cob products,

unpublished

Yes

Zea Sciences

Ltd

Α3/12 White, G.A 2011 Examination of Powdered Corn

Cob

GC Laboratories Ltd

Report No J18496

GLP

Yes Zea Sciences

Ltd

Β3/8 White, G.A 2011 Determination of particle size

of Powdered Corn Cob and

Eradirat pellets, and

determination of attrition and

friability characteristics of

Eradirat pellets.

GC Laboratories Ltd

Report No J18895

GLP

Yes Zea Sciences

Ltd

B5/01 Delmar Products Ltd

1995, Trial No 1

1995 The Orbis Molasses Pellet an

all natural and organic

rodenticide to control rats and

mice. Field test results and

appraisals

Trial No 1

Not GLP, Unpublished

Yes

Zea Sciences

Ltd


1995, Trial No 2





appraisals

Trial No 2


Yes

Zea Sciences

Ltd


1995, Trial No 3





appraisals

Trial No 3


Yes

Zea Sciences

Ltd


28


1995, Trial No 4





appraisals

Trial No 4


Yes

Zea Sciences

Ltd


1995, Trial No 5





appraisals

Trial No 5


Yes

Zea Sciences

Ltd


1995, Trial No 6





appraisals

Trial No 6


Yes Zea Sciences

Ltd


1995, Trial No 7





appraisals

Trial No 7


Yes

Zea Sciences

Ltd


1995, Trial No 8





appraisals

Trial No 8


Yes Zea Sciences

Ltd


1995, Trial No 9





appraisals

Trial No 9


Yes

Zea Sciences

Ltd


1995, Trial No 10





appraisals

Trial No 10


Yes

Zea Sciences

Ltd

B5/11 Morgan DR, Eason

CT 2002,

LC0203/053

2002 Efficacy of Eradirat against

Sprague-Dawley rats

Landcare Research Contract

Report LC0203/053, Study

number GLP 02/10/01

GLP, Unpublished

Yes

Zea Sciences

Ltd


29

B5/12 Kable JR

2002, GLP31745

2002 Effects of Eradirat on rats

when fed ad libitum

Celsius Laboratory Group,

Study ID number GLP31745

GLP, Unpublished

Yes

Zea Sciences

Ltd

B5/13 Hoyer K

2002, GLP31755

2002 Confirming effects of Eradirat

on rats when fed ad libitum



GLP, Unpublished

Yes

Zea Sciences

Ltd

B5/14 Morgan DR, Eason

CT 2003,

LC0203/061

2002 Efficacy of Eradirat against

Sprague-Dawley Laboratory

Rats and Assessment of Mode

of Action and Effects.


Report LC0203/061


Yes

Zea Sciences

Ltd

B5/16 Prescott, Dr C.V &

Buckle, Dr A

2006 Pilot field study investigating

the behaviour of Norway

Rats, Rattus norvegicus

(Berkenhout, 1769) on a mixed

farm in Wales when “Natrocell

Pro” rodenticide bait,

containing the active substance

powdered corn cob, was

applied.

Vertebrate Pests Unit, School

of Biological Sciences, The

University of Reading

Yes Zea Sciences

Ltd

Prescott, Dr C.V &

Buckle, Dr A

2006 Field efficacy evaluation of

“Natrocell Pro” rodenticide

bait, containing the active

substance powdered corn cob,

for the control of Norway Rats,

Rattus norvegicus (Berkenhout,

1769) infesting an agricultural

holding on the Anglo-Welsh

border.

Vertebrate Pests Unit, School

of Biological Sciences, The

University of Reading

Yes Zea Sciences

Ltd

B5/17 Morgan DR 2002,

LC0203/055

2002 Efficacy of Eradimouse against

Wild House Mice


Report LC0203/055


Yes

Zea Sciences

Ltd

B5/18 Hoyer K

2002, GLP31754

2002 Effects of Eradimouse on mice

when fed ad libitum



GLP, Unpublished

Yes

Zea Sciences

Ltd


30


LC0203/121

2003 Susceptibility of the chicken

(Gallus gallus) to Eradimouse.


Report LC0203/121

Study Number GLP03/01/03

GLP, Unpublished

Yes Zea Sciences

Ltd


LC0203/122

2003 Susceptibility of the duck

(Anas Platyrhynchos) to

Eradimouse.


Report LC0203/122


GLP, Unpublished

Yes Zea Sciences

Ltd


LC0203/117

2003 Susceptibility of the guinea pig

(Cavia porcellus) to

Eradimouse. Landcare

Research Contract Report

LC0203/117


GLP, Unpublished

Yes Zea Sciences

Ltd


LC0203/116

2003 Susceptibility of the European

rabbit (Oryctolagus cuniculus

cuniculus) to Eradirat.


Report LC0203/116


GLP, Unpublished

Yes Zea Sciences

Ltd


LC0203/115

2003 Susceptibility of the brushtail

possum (Trichosurus

vulpecula) to Eradirat.


Report LC0203/115


GLP, Unpublished

Yes Zea Sciences

Ltd


LC0203/120

2003 Susceptibility of the ferret

(Mustela furo) to Eradirat.


Report LC0203/120


GLP, Unpublished

Yes Zea Sciences

Ltd


LC0203/118

2003 Susceptibility of the cat (Felis

catus) to Eradirat.


Report LC0203/118


GLP, Unpublished

Yes Zea Sciences

Ltd


LC0203/119

2003 Susceptibility of the dog

(Canis familiaris) to Eradirat.


Report LC0203/119


GLP, Unpublished

Yes Zea Sciences

Ltd


31

B6/1 Rothstein EC 1994,

#9412329

1994 Acute oral toxicity study LD50

Leberco Testing Inc, Assay

#9412329

GLP, Unpublished

Yes

Zea Sciences

Ltd

i Section Number/Reference Number should refer to the section number in Doc III-A or III-B. If the study

is non-key, and hence not summarised in Doc III but mentioned in Doc II, it should be included in the

reference list alongside related references and its location in Doc II indicated in brackets. (If there is a

need to include a cross-reference to PPP references then an additional column can be inserted).

i Author’s Name should include the author’s surname before initial (s) to enable the column to be sorted

alphabetically. If the Human Rights Charter prevents author’s surnames on unpublished references being

included in non-confidential documents, then it will be necessary to consider including ‘Unpublished

[number/year & letter] ’ in Doc II, and both ‘ Unpublished [number/year & letter]’ and the ‘Authors

Name’ in the reference list’. This may necessitate the need for an additional column to state whether a

reference is unpublished which can then be sorted.

i Title, Source (where different from company), Company, Report No., GLP (where relevant),

(Un)Published should contain information relevant to each item (ideally on separate lines within the

table cell for clarity). If useful, the name of the electronic file containing the specific study/reference

could be added in brackets.

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