Division Core data set and additional data set

Name and address

Contact person

Manufacturer and formulator of the biocidal product and the micro-organism(s) (names, addresses, including location of plant(s))

Trade name or proposed trade name

Manufacturer’s development code and number of the biocidal product, if appropriate

Formulation type and nature of the biocidal product

Where the biocidal product contains an active substance that has been manufactured in locations or according to processes or from starting materials other than those of the active substance evaluated for the purpose of approval pursuant to Article 9 of this Regulation, evidence has to be provided that technical equivalence has been established in accordance with Article 54 of this Regulation or has been established, following an evaluation having started before 1 September 2013, by a competent authority designated in accordance with Article 26 of Directive 98/8/EC

Biological properties of the micro-organism in the biocidal product

Colour (at 20 °C and 101,3 kPa)

Odour (at 20 °C and 101,3 kPa)

Acidity, alkalinity and pH value

Relative density

Effects of light

Effects of temperature and humidity

Reactivity towards the container

Other factors affecting stability

Wettability

Suspensibility and suspension stability

Wet sieve analysis and dry sieve test

Emulsifiability, re-emulsifiability, emulsion stability

Particle size distribution content of dust/fines, attrition and friability

Persistent foaming

Flowability/Pourability/Dustability

F6...

...

...

Physical compatibility

Chemical compatibility

Biological compatibility

Surface tension

Viscosity

Analytical method for determining the concentration of the micro-organism(s) and substances of concern in the biocidal product

Analytical methods for monitoring purposes including recovery rates and the limit of quantification and detection for the active substance, and for residues thereof, in/on food of plant and animal origin or feeding stuffs and other products where relevant (not necessary if neither the active substance nor the article treated with it does not come into contact with food-producing animals, food of plant and animal origin or feeding stuffs)

Function and mode of control

Representative pest organism(s) to be controlled and products, organisms or objects to be protected

Effects on representative target organisms

Likely concentration at which micro-organism will be used

Mode of action

The proposed label claims for the product

Efficacy data to support these claims, including any available standard protocols, laboratory tests, or field trials used including performance standards, where appropriate and relevant

Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies

Observations on undesirable or unintended side effects

Field of use envisaged

Product-type

Detailed description of intended use

User e.g. industrial, trained professional, professional or general public (non-professional)

Method of application and a description of this method

Application rate and if appropriate the final concentration of the biocidal product or the micro-organism active substance in a treated article or the system in which the product is to be used (e.g. in the application device or bait)

Any particular information relating to the geographical location or climatic variations including necessary waiting periods for re-entry or necessary withdrawal period or other precautions to protect human health, animal health and the environment

Proposed instructions for use

Information on human exposure associated with the proposed/expected uses and disposal

Information on environmental exposure associated with the proposed/expected uses and disposal

TOXICOLOGICAL PROFILE FOR HUMANS AND ANIMALS

Skin corrosion or irritation

Eye irritation

Skin sensitisation

Respiratory sensitisation

• Classification using the tiered approach to classification of mixtures for acute toxicity in Regulation (EC) No 1272/2008 is the default approach

Oral

Inhalation

Dermal

Additional acute toxicity studies

Information on dermal absorption if required

• non-active substance(s) (i.e. substance(s) of concern), or

• a mixture that a substance(s) of concern is a component of

  If insufficient data are available for a non-active substance(s) and cannot be inferred through read-across or other accepted non-testing approaches, targeted test(s) described in Annex II, shall be carried out for the substance(s) of concern or a mixture that a substance(s) of concern is a component of

For biocidal products that are intended to be authorised for use with other biocidal products, the risks to humans, animals and the environment arising from the use of these product combinations shall be assessed. As an alternative to acute toxicity studies, calculations can be used. In some cases, for example where there are no valid data available of the kind set out in column 3, this may require a limited number of acute toxicity studies to be carried using combinations of the products

Residues in or on treated articles, food and feedingstuffs

• Where there are valid data available on each of the components in the mixture and synergistic effects between any of the components are not expected, classification of the mixture can be made according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP)

• Where valid data on the components are not available or where synergistic effects may be expected then testing of components and/or the biocidal product itself may be necessary

Further studies chosen from among the endpoints referred to in Section 8 of Annex II ‘Micro-organisms’ for relevant components of the biocidal product or the biocidal product itself may be required if the data on the active substance cannot give sufficient information and if there are indications of risk due to specific properties of the biocidal product

Effects on any other specific non-target organisms (flora and fauna) believed to be at risk

If the biocidal product is in the form of bait or granules

Supervised trials to assess risks to non-target organisms under field conditions

Studies on acceptance by ingestion of the biocidal product by any non-target organisms thought to be at risk

Secondary ecological effect e.g. when a large proportion of a specific habitat type is treated

Foreseeable routes of entry into the environment on the basis of the use envisaged

Where relevant, all the information required in Section 9 of Annex II ‘Micro-organisms’ may be required for the product

For products that are used outside, with direct emission to soil, water or surfaces, the components in the product may influence the fate and behaviour (and ecotoxicity) of the active substance. Data are required unless it is scientifically justified that the fate of the components in the product is covered by the data provided for the active substance and other identified substances of concern

If the biocidal product is to be sprayed outside or if potential for large scale formation of dust is given then data on overspray behaviour may be required to assess risks to bees under field conditions

Recommended methods and precautions concerning: handling, storage, transport or fire

Measures in the case of an accident

Controlled incineration

Others

Packaging and compatibility of the biocidal product with proposed packaging materials

Procedures for cleaning application equipment where relevant

Monitoring plan to be used for the active micro-organism and other micro-organism(s) contained in the biocidal product including handling, storage, transport and use

Indication on the need for the biocidal product to carry the biohazard sign specified in Annex II to Directive 2000/54/EC

Precautionary statements including prevention, response, storage and disposal

Proposals for safety-data sheets should be provided, where appropriate

Packaging (type, materials, size, etc.), compatibility of the product with proposed packaging materials to be included

The key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed